ORTHO

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
		ORTHOPEDIC DRIVEN IMAGING, LLC	5	N	2026-01-01	4424 Nw 13th St Ste B6 Gainesville FL US 32609
1052235	1052235	ORTHO-CYCLE CO.	1	N	2026-01-01	2026 Scott St HOLLYWOOD FL US 33020
1058152	1000222089	ORTHOMERICA PRODUCTS, INC.	1	Y	2026-01-01	6333 N Orange Blossom Trl ORLANDO FL US 32810
1064129	3002684506	Orthopedic Designs North America, Inc.	1	N	2026-01-01	5912 Breckenridge Parkway Suite F Tampa FL US 33610
1121924	1121924	ORTHODONTIC SUPPLY & EQUIPMENT CO., INC.	1	Y	2026-01-01	7851 Airpark Rd Ste 202 GAITHERSBURG MD US 20879
1319681	1000136573	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	100 Indigo Creek Dr Rochester NY US 14626
1319808	1000305841	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	1000 LEE RD. Rochester NY US 14606
1319809	1000305840	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	513 Technology Blvd. ROCHESTER NY US 14626
1528450	1000122536	Ortho-Clinical Diagnostics, Inc.	1	N	2026-01-01	2005 East State Street, Suite 100 ATHENS OH US 45701
1722511	1000143502	ORTHO DEVELOPMENT CORP.	1	N	2026-01-01	12187 SOUTH BUSINESS PARK DR. DRAPER UT US 84020
1937100	1937100	Ortho Solutions LC	1	N	2026-01-01	8050 Hawk Ridge Trail Lake Saint Louis MO US 63367
2029096	1000160800	ORTHO KINETICS CORP.	1	N	2026-01-01	2588 Progress St Ste 13 VISTA CA US 92081
2032830	3004167986	ORTHOPEDIC SCIENCES, INC	1	N	2026-01-01	6600 College Blvd Ste 138 Overland Park KS US 66211
2081322	2081322	ORTHO ORGANIZERS, INC.	1	Y	2026-01-01	800 King George Blvd, Suite 100 Savannah GA US 31419
2183449	2183449	ORTHOFIX US LLC	1	Y	2026-01-01	3451 Plano Parkway Lewisville TX US 75056
2246970	2246970	ORTHOFEET, INC.	1	N	2026-01-01	10 Maple Street Norwood NJ US 07648
2250051	2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	1001 US Highway 202 RARITAN NJ US 08869
2518634	2518634	ORTHOPLI CORP.	1	N	2026-01-01	10061 SANDMEYER LN. PHILADELPHIA PA US 19116
2649784	2649784	ORTHO-TAIN, INC.	1	N	2026-01-01	CARR 861, K.M. 5.0, BARRIO PINAS Toa Alta PR US 00953
3019455	3019455	ORTHO-MED, INC.	1	Y	2026-01-01	14875 SW 72nd Ave Tigard OR US 97224
9680825	3002807827	ORTHOFIX SRL	1	N	2026-01-01	VIA DELLE NAZIONI 9 BUSSOLENGO Verona IT 37012
9710113	3003348399	ORTHODONTIC MANUFACTURER SIA SRL	1	N	2026-01-01	ZONA INDUSTRIALE VIA VANDRA ROCCA D EVANDRO Caserta IT 81040
3000308930	3000308930	Ortho-Clinical Diagnostics European Support Center	1	N	2026-01-01	1500 Boulevard Sebastien Brant B.P. 30335 Illkirch, CEDEX Bas-Rhin FR 67411
3000327445	3000327445	ORTHOPEDIATRICS CANADA ULC	1	N	2026-01-01	1111 Chomedey Highway (A13) Laval Quebec CA H7W 5J8
3002642396	3002642396	Ortho Clinical Diagnostics	1	N	2026-01-01	1 International Business Park, The Synergy #01-11/12 Singapore South West SG 609917

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
118939	1521193336	P850007	PHYSIO-STIM(TM) I & II MODEL 6000 & 7000	LOF	1986-02-21
118939	2036814692	P210035	AccelStimTM Bone Growth Stimulator	LOF	2022-05-03
118939	1018371565	P170036	M6-C Artificial Cervical Disc	MJO	2019-02-06
312213	1385088354	P100001	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS	SEI	2011-07-20
312288	1385088354	P100001	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS	SEI	2011-07-20
312290	1385088354	P100001	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS	SEI	2011-07-20
312670	1385088354	P100001	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS	SEI	2011-07-20
312213	1433667431	P090028	VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS	LOM	2011-05-11
312288	1433667431	P090028	VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS	LOM	2011-05-11
312290	1433667431	P090028	VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS	LOM	2011-05-11
312670	1433667431	P090028	VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS	LOM	2011-05-11
118939	1316985199	P030034	CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM	LOF	2004-12-23
312213	1909123349	P030026	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR	SEI	2004-03-04
312288	1909123349	P030026	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR	SEI	2004-03-04
312290	1909123349	P030026	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR	SEI	2004-03-04
312670	1909123349	P030026	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR	SEI	2004-03-04
312213	1039148954	P030024	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR	SEI	2004-03-04
312288	1039148954	P030024	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR	SEI	2004-03-04
312290	1039148954	P030024	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR	SEI	2004-03-04
312670	1039148954	P030024	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR	SEI	2004-03-04
312213	1876315254	P010021	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR	MZO	2001-08-30
312288	1876315254	P010021	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR	MZO	2001-08-30
312290	1876315254	P010021	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR	MZO	2001-08-30
312670	1876315254	P010021	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR	MZO	2001-08-30
312213	1385779327	P000044	VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR	LOM	2001-04-27
312288	1385779327	P000044	VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR	LOM	2001-04-27
312290	1385779327	P000044	VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR	LOM	2001-04-27
312670	1385779327	P000044	VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR	LOM	2001-04-27
312213	2070006446	P000014	VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS	SEI	2000-09-29
312288	2070006446	P000014	VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS	SEI	2000-09-29
312290	2070006446	P000014	VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS	SEI	2000-09-29
312670	2070006446	P000014	VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS	SEI	2000-09-29
50430	1127110763	K994370	ORTHO DEVELOPMENT BALANCED KNEE SYSTEM	JWH	2000-03-24
118939	1276477117	K994217	BLACKSTONE SPINAL FIXATION SYSTEM	MNH	2000-02-28
312213	1343396273	K994145	VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS	JIS	1999-12-22
312290	1343396273	K994145	VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS	JIS	1999-12-22
312670	1343396273	K994145	VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS	JIS	1999-12-22
50430	1563859401	K990986	CONTOUR SPINAL SYSTEM	KWP	1999-10-14
113251	1611208739	K984331	ODI ULTIMATE COMPRESSION HIP SCREW	HWC	1999-01-20
118939	1033786031	K983814	GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM	JDO	1999-01-14
49956	1576467495	K983814	GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM	JDO	1999-01-14
312213	1545196239	K983690	VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK	MOI	1999-02-02
312288	1545196239	K983690	VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK	MOI	1999-02-02
312290	1545196239	K983690	VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK	MOI	1999-02-02
312670	1545196239	K983690	VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK	MOI	1999-02-02
312290	1956116669	K983674	VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS	JMM	1999-01-29
312213	1721546618	K983513	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1998-11-03
312288	1721546618	K983513	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1998-11-03
312290	1721546618	K983513	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1998-11-03
312670	1721546618	K983513	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1998-11-03
312213	1757233346	K983507	VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY	JJY	1998-11-04
312288	1757233346	K983507	VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY	JJY	1998-11-04
312290	1757233346	K983507	VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY	JJY	1998-11-04
312670	1757233346	K983507	VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY	JJY	1998-11-04
50430	1436958723	K982389	ODC B2 BIPOLAR CUP	KWY	1998-10-07
312671	1776148958	K981373	ALKPHASE-B ASSAY KIT	CIN	1998-05-27
312671	1777891829	K981364	PYRILINKS-D ASSAY KIT	JMM	1998-08-13
14620	1897368235	K980864	POWER COINS GLOW IN THE DARK LIGATURES	ECI	1998-04-20
14620	2066992520	K980436	CLASS III REVERSE PULL FACEMASK	DZB	1998-04-27
14620	1107229424	K980245	NITOM LOCKING FACEBOW	DZB	1998-04-21
5364	1302654093	K980195	FACEBOW	DZB	1998-03-11
14620	1753857539	K980195	FACEBOW	DZB	1998-03-11
5364	1536529311	K980151	RELEASABLE FORCE MODULE	DZB	1998-04-06
14620	1604255330	K980151	RELEASABLE FORCE MODULE	DZB	1998-04-06
118939	1264173219	K974885	BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM	KWQ	1998-06-17
312213	1194774061	K974644	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJX	1998-01-13
312288	1194774061	K974644	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJX	1998-01-13
312290	1194774061	K974644	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJX	1998-01-13
312670	1194774061	K974644	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJX	1998-01-13
49956	1350399495	K974186	ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING	JDW	1998-03-18
118939	1578409811	K974186	ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING	JDW	1998-03-18
312671	2019739078	K974111	QUIDEL CH50 EQ EIA	DAE	1998-07-29
118939	1307133538	K973944	ORTHOFIX FEMORAL NAILING SYTEM	HSB	1997-12-19
49956	1331720571	K973944	ORTHOFIX FEMORAL NAILING SYTEM	HSB	1997-12-19
5364	1136253979	K973776	REFLECTIONS	DYW	1997-11-21
312213	1796900905	K973517	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1997-09-25
312288	1796900905	K973517	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1997-09-25
312290	1796900905	K973517	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1997-09-25
312670	1796900905	K973517	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	1997-09-25
312290	1596089087	K973331	VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)	DBF	1997-10-22
118939	1454373460	K972768	BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM	HRX	1997-09-25
50430	1135165855	K971435	HEADLOC CERAMIC FEMORAL HEADS	LZO	1997-07-09
50430	1230379591	K971426	HEADLOC CERAMIC HEAD	LZO	1997-07-09
50430	1808030916	K970675	HEADLOC CERAMIC HEAD	LZO	1997-08-22
312213	1522269507	K970643	VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)	CHP	1997-03-18
312288	1522269507	K970643	VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)	CHP	1997-03-18
312290	1522269507	K970643	VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)	CHP	1997-03-18
312670	1522269507	K970643	VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)	CHP	1997-03-18
312213	1836532856	K965142	VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)	CEC	1997-03-18
312288	1836532856	K965142	VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)	CEC	1997-03-18
312290	1836532856	K965142	VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)	CEC	1997-03-18
312670	1836532856	K965142	VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)	CEC	1997-03-18
312290	1845499011	K964982	VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)	CEP	1997-02-20
312213	1483979437	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	1997-02-18
312288	1483979437	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	1997-02-18
312290	1483979437	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	1997-02-18
312452	1483979437	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	1997-02-18
312600	1483979437	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	1997-02-18
312670	1483979437	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	1997-02-18
312213	1417738613	K964721	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)	KLI	1996-12-18
312288	1417738613	K964721	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)	KLI	1996-12-18
312290	1417738613	K964721	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)	KLI	1996-12-18
312670	1417738613	K964721	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)	KLI	1996-12-18
312213	1183794043	K964720	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)	CGJ	1997-02-04
312288	1183794043	K964720	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)	CGJ	1997-02-04
312290	1183794043	K964720	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)	CGJ	1997-02-04
312670	1183794043	K964720	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)	CGJ	1997-02-04
312213	1409395610	K962919	VITROS IMMUNODIAGNOSTIC SYSTEM	KHO	1996-10-18
312288	1409395610	K962919	VITROS IMMUNODIAGNOSTIC SYSTEM	KHO	1996-10-18
312290	1409395610	K962919	VITROS IMMUNODIAGNOSTIC SYSTEM	KHO	1996-10-18
312670	1409395610	K962919	VITROS IMMUNODIAGNOSTIC SYSTEM	KHO	1996-10-18
50430	1468223597	K962448	PRIMALOC CEMENTED HIP SYSTEM	KWY	1996-09-19
5364	1607155727	K961754	SAFETY RELEASE MODULE	DZB	1996-07-10
24660	1935388956	K961754	SAFETY RELEASE MODULE	DZB	1996-07-10
118939	1687159133	K961725	OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION	JDX	1996-08-01
49956	1926829554	K961027	ORTHOFIX TIBIAL NAILING SYSTEM	HSB	1996-05-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HRS	49	2021-04-20
HSB	47	2026-05-19
KWQ	35	2022-02-11
NKB	32	2021-07-14
LOM	24	2011-07-20
MAX	20	2024-05-28
JJX	20	2004-09-27
KWP	19	2014-01-30
KTT	18	2024-12-03
OAN	16	2024-03-15
ODP	16	2021-08-31
JIT	16	2017-05-16
JWH	15	2024-10-25
MNI	15	2008-03-13
DCK	14	2017-07-14
LPH	13	2024-10-11
MQP	13	2007-01-25
HWC	12	2022-04-13
NKG	12	2021-07-30
DZB	12	2000-06-09
JJY	12	1998-11-04
LBS	11	2012-09-07
CIG	10	2019-04-26
JLW	10	2008-12-22
JMO	10	2006-06-15
KLS	10	2004-11-30
OBT	9	2022-10-24
CIX	9	2019-06-07
DHA	8	2024-05-08
NIG	8	2023-08-09
QVP	8	2023-05-05
LRK	8	2022-05-31
NBC	8	2021-10-04
LOL	8	2006-09-15
CEW	7	2023-09-05
DHX	7	2023-08-23
OUR	7	2021-03-25
CDN	7	2019-03-14
MNH	7	2006-09-26
JIS	7	2003-08-13

PMA#

VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

2023-01-24

ORTHO-CLINICAL DIAGNOSTICS100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP100001 Supplement NumberS017 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reas...

VITROS Anti-HBc IgM

2023-01-24

Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP030026 Supplement NumberS037 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplemen...

VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

2023-01-24

Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP090028 Supplement NumberS018 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplemen...

PhysioStim®, SpinalStim®

2022-06-14

Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP850007 Supplement NumberS046 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/com...

CervicalStim®

2022-06-14

Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP030034 Supplement NumberS017 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/com...

200 records. Showing 1-40. Next

MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

2024-12-05

Orthocon, Inc.

VersaTap? Suture Anchor (ADP050); VersaPEEK? Suture Anchor (APP002); MicroTi? Suture Anchor (ATP003-M); VersaLat? Ti Suture Anchor (ADP021-TI); VersaLat? Suture Anchor (ADP021-PK)

2024-08-29

Ortho-Design (Pty), Ltd.

Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System;

2024-06-20

Orthofix Medical, Inc.

200 records. Showing 1-40. Next

80 records. Showing 1-40. Next

ORTHO

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