Bayer HealthCare, LLC

Matched from indexed company URL: Bay Corporation

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2243252	2243252	Bayer HealthCare, LLC	1	N	2026-01-01	36 Columbia Rd Morristown NJ US 07960
2248903	3000206585	BAYER HEALTHCARE LLC, CONSUMER CARE	1	Y	2026-01-01	36 Columbia Rd MORRISTOWN NJ US 07960
2520313	2520313	Bayer Medical Care Inc.	1	N	2026-01-01	1 Bayer Drive INDIANOLA PA US 15051
3004056159	3004056159	Bayer Medical Care Inc.	1	N	2026-01-01	625 Alpha Dr Pittsburgh PA US 15238
3004773823	3004773823	Bayshore Dental Studio LLC	1	Y	2026-01-01	501 E Jackson St TAMPA FL US 33602
3005810333	3005810333	BAY SHORE MEDICAL EQUIPMENT, LLC	1	Y	2026-01-01	61 Deer Lane Manorville NY US 11949
3006791331	3006791331	Bayer Medical Care Inc.	1	N	2026-01-01	150 Victory Road Saxonburg PA US 16056
3006948155	3009865005	Bayan Saleh	1	N	2026-01-01	600 Atlantis Rd Melbourne FL US 32904
3008341245	3008341245	BAY CORPORATION	1	N	2026-01-01	867 Canterbury Rd Westlake OH US 44145
3010684903	3010684903	BAYLAND TECHNOLOGIES, INC.	1	Y	2026-01-01	4500 W. 34th Street Ste. K Houston TX US 77092
3010876315	3010876315	BAYOU STATE CROWN & BRIDGE LAB	1	N	2026-01-01	10921 S. Havenpark Ct Baton Rouge LA US 70815
3011334555	3011334555	Bayer Medical SRL	1	N	2026-01-01	Block B Lot 1 Metro Park Barreal de Heredia CR 6-3060
3012469182	3012469182	Bayer Medical Care B.V.	1	N	2026-01-01	Avenue Ceramique 27 Maastricht Limburg NL 6221 KV
3014317462	3014317462	Bay Materials, LLC	1	Y	2026-01-01	48450 Lakeview Blvd Fremont CA US 94538
3015128453	3015128453	BAY MEDICAL	1	Y	2026-01-01	460 Valley Drive Brisbane CA US 94005
3017517827	3017517827	BAYLAB USA	1	N	2026-01-01	2230 LBJ FREEWAY Suite 100 Dallas TX US 75234
3020689212	3020689212	Baylis Medical Technologies Inc.	1	Y	2026-01-01	11320 State Route 9 Champlain NY US 12919
3020968442	3020968442	BAYLIS MEDICAL TECHNOLOGIES INC.	1	N	2026-01-01	2645 Matheson Blvd E Mississauga Ontario CA L4W5S4
0	0	BAY SALES, LLC	5	Y	2020-04-25	113 Fillmore St Bristol PA US 19007
1910953	1910953	BAYER HEALTHCARE LLC	1	N	2020-04-25	12707 SHAWNEE MISSION PKWY Shawnee Mission KS US 66216
3003604186	3003604186	BAY STATE SPECIALTY COMPANY	1	Y	2020-04-25	101 Charles Eldridge Drive Lakeville MA US 02347
3003692456	3003692456	BAY ADVANCED TECHNOLOGIES, LLC	1	N	2020-04-25	8100 CENTRAL AVE Newark CA US 94560
3004572127	3004572127	BAYLIS MEDICAL COMPANY INC.	1	Y	2020-04-25	1320 ROUTE 9 CHAMPLAIN NY US 12919
3006333128	3006333128	BAYERISCHE MOTOREN WERKE AG	1	N	2020-04-25	Petuelring 130 Munchen Bayern DE 80809
3009536037	3009536037	BAYA TECHNOLOGIES LTD.	1	N	2020-04-25	Ben Zion Galis 9 Petach Tikva HaMerkaz IL 4927909

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
B1285106085H50	HOSE ASSEMBLY, STD - O2 Low Pressure Hose Assembly	440-835-2212	sales@baycorp.com
B1285107285H50	HOSE ASSEMBLY, STD - O2 Low Pressure Hose Assembly	440-835-2212	sales@baycorp.com

baycorp.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
130338	1277407081	P080003	SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	OTE	2011-02-11
188736	1802181199	P020014	ESSURE SYSTEM	HHS	2002-11-04
130338	1950956967	K992731	E.CAM COMPUTER	KPS	1999-11-10
130338	1612869077	K992135	SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM	LNH	1999-09-08
296315	1157505093	K990284	BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE	DXF	2001-02-01
38251	1344283833	K984418	UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET	DXT	1999-03-11
223370	1656518479	K982877	MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE	LYY	1998-11-30
38251	1200476669	K982814	MEDRAD VISTRON CT INJECTOR SYSTEM	DXT	1998-10-09
130338	2034493743	K982795	PHILIPS BUCKY VISION	MQB	1998-11-24
130338	2008391344	K982787	ASTEION CT SCANNER, TSX-021A	JAK	1998-10-21
38251	1538179113	K980417	MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V	LNH	1998-05-04
130338	1230803553	K980176	HISPEED QX/I CT SCANNER SYSTEM	JAK	1998-04-13
130338	1951462250	K971684	MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)	LNH	1997-08-05
130338	1505251186	K963093	SIREMOBIL COMPACT	OXO	1996-09-03
130338	1309145019	K962738	MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS	KPS	1996-10-10
223370	1253201889	K953590	COMFIT	LYY	1996-06-27
7743	1781752200	K944983	MEDRAD COUNTERPOISE SYSTEM	JAK	1994-11-29
38251	1781752200	K944983	MEDRAD COUNTERPOISE SYSTEM	JAK	1994-11-29
38251	1453694574	K935668	MEDRAD SPECTRIS MR INJECTOR	DXT	1995-09-25
38251	1756560956	K934086	MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE	DXT	1995-06-15
38251	1429888083	K924116	MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD	DXT	1993-01-21
130338	1844539091	K913732	MAMMOGRAPHIC X-RAY SYSTEM	IZH	1992-02-03
130338	1755080539	K910115	PHILIPS BV-29 IMAGING SYSTEM	OXO	1991-02-20
7743	1329681580	K903390	MEDRAD MARK V-PLUS INJECTOR	DXT	1990-09-26
38251	1329681580	K903390	MEDRAD MARK V-PLUS INJECTOR	DXT	1990-09-26
130338	1335829148	K902983	SIEMEN'S SIREMOBILE II C-ARM	JAA	1990-11-06
7743	1276790125	K870243	BURNETT TMJ APPLIANCE	EAG	1987-02-24
38251	1276790125	K870243	BURNETT TMJ APPLIANCE	EAG	1987-02-24
38251	1455622968	K831188	CONNECTOR TUBE	DOY	1983-05-09
7743	1386746254	K822536	MARK V	DXT	1982-09-28
38251	1386746254	K822536	MARK V	DXT	1982-09-28
38251	1402979606	K810924	MEDRAD HIGH PRESSURE CONECTING TUBE	DWE	1981-04-17
130338	1826455336	K802047	AMX-III	IZL	1980-10-23
38251	1316381139	K800823	QUICK FILL	DXT	1980-04-29
7743	1099162770	K252891	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)	DXT	2026-02-13
38251	1099162770	K252891	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)	DXT	2026-02-13
296315	1811811242	K251158	PowerWire® 14 Radiofrequency Guidewire Kit	PDU	2025-09-11
345602	1154903956	K250893	Ball Joint Guide Array (66295)	HAW	2025-09-04
38251	1387724812	K241849	MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)	IZQ	2024-11-05
296315	2070779572	K232562	PowerWire Radiofrequency Guidewire Kit	PDU	2024-02-28
296315	1486569988	K230571	RFP-100A Connector Cable (Single Use)	DSA	2023-05-30
280825	2036624710	K212302	BAYLAB 3-Ply Surgical Mask (BEACON I)	FXX	2021-12-07
38251	1648970145	K200280	MEDRAD Imaging Bulk Package Transfer Spike	PQH	2020-07-30
223370	1898466221	K200019	Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)	LZA	2020-04-06
223370	1557016365	K193581	Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster	LZA	2020-03-20
7743	2033185571	K182276	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit	DXT	2018-11-01
38251	2033185571	K182276	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit	DXT	2018-11-01
7743	2024714756	K182273	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	DXT	2018-11-01
38251	2024714756	K182273	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	DXT	2018-11-01
72356	2024714756	K182273	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	DXT	2018-11-01
223370	1400658741	K182241	Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs	LZA	2019-03-11
180315	1361713258	K180079	Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation	BZQ	2018-05-07
38251	1595211460	K173913	MEDRAD® Imaging Bulk Package Transfer Set	PQH	2018-05-04
7743	1161549562	K173773	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	DXT	2018-08-17
38251	1161549562	K173773	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	DXT	2018-08-17
72356	1161549562	K173773	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	DXT	2018-08-17
180315	1340694962	K171836	EarlySense Bed Sensing Unit	BZQ	2018-01-04
180315	1480312534	K152911	EarlySense Insight Sytem	BZQ	2016-05-06
59665	1304371515	K152852	ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)	NUH	2015-12-22
296315	1763865561	K151951	Destino Reach	DYB	2015-09-22
7743	1899207769	K143538	MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit	DXT	2015-08-14
38251	1899207769	K143538	MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit	DXT	2015-08-14
296315	1738855402	K140406	DESTINO TWIST, STEERABLE GUIDING SHEATH	DYB	2014-04-17
180315	1809578431	K133661	CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM	BZQ	2014-06-13
7743	2013662414	K132928	MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE	DXT	2014-01-23
38251	2013662414	K132928	MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE	DXT	2014-01-23
130338	1410046629	K132376	DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T	LNH	2013-11-15
296315	1358736166	K132374	BAYLIS MEDICAL RF PERFORATION PROBE V2.0	GEI	2013-08-30
130338	1593227349	K131937	VOLUSON I/E	IYN	2013-09-24
38251	1100513449	K131517	MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING	FPK	2013-08-02
180315	2045571211	K131379	EARLYSENSE	BZQ	2013-12-18
130338	1586415267	K130842	ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES	IZI	2013-05-21
180315	1136598694	K130171	FLIGHT 60 VENTILATOR	CBK	2014-04-08
130338	1034599877	K122286	MAMMOMAL INSPIRATION	MUE	2013-02-22
130338	1891129542	K122234	OEC 9900 ELITE	OWB	2012-08-16
130338	1369075411	K120613	OEC 9900 ELITE	OXO	2012-04-06
296315	1144825111	K120459	STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO	DYB	2012-06-29
7743	1173632912	K113133	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE	DXT	2011-12-15
38251	1173632912	K113133	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE	DXT	2011-12-15
130338	1221117743	K112213	VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2011-09-01
7743	1684613119	K112086	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE	DXT	2011-10-14
38251	1684613119	K112086	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE	DXT	2011-10-14
130338	1934108122	K111646	ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR	MUE	2011-12-08
296315	1943015122	K101615	POWERWIRE RADIOFREQUENCY GUIDEWIRE	PDU	2010-07-28
7743	1275937558	K100798	MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C	FRN	2010-06-23
38251	1275937558	K100798	MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C	FRN	2010-06-23
130338	1263295671	K092140	GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND	IYO	2009-08-21
38251	1455367923	K083723	A6 LUER ACCESS DEVICE	FPA	2009-06-05
7743	1007638468	K082905	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC	DXT	2009-01-12
38251	1007638468	K082905	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC	DXT	2009-01-12
72356	1007638468	K082905	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC	DXT	2009-01-12
130338	1786862609	K082816	GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM	JAK	2008-10-08
130338	1329551727	K082761	GE LIGHTSPEED 7.2 CT SCANNER SYSTEM	JAK	2008-10-08
7743	1462561168	K082458	P3T ABDOMEN	JAK	2008-10-17
38251	1462561168	K082458	P3T ABDOMEN	JAK	2008-10-17
130338	1253576963	K081496	OPTIMA PET/CT 560	KPS	2008-06-12
7743	1576350984	K080297	MEDRAD INTEGO PET INFUSION SYSTEM	FRN	2008-06-17
38251	1576350984	K080297	MEDRAD INTEGO PET INFUSION SYSTEM	FRN	2008-06-17
38251	1973235202	K073051	MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY	FRN	2008-05-30
7743	1037544538	K072886	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T	DXT	2007-12-21
38251	1037544538	K072886	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T	DXT	2007-12-21
223370	1753398506	K070008	POWDERED VINYL PATIENT EXAMINATION GLOVES	LYZ	2007-02-08
130338	1566237926	K063559	ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5	LNH	2007-01-04
7743	1558272264	K063090	MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY	IZQ	2007-03-27
38251	1558272264	K063090	MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY	IZQ	2007-03-27
130338	1605439135	K060993	GE LOGIQ P5 AND A5	IYN	2006-05-03
59665	1460791089	K052259	DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406	GEH	2005-12-14
38251	1881646712	K051499	INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET	FPA	2005-06-22
7743	1784581612	K050456	MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM	DXT	2005-06-17
38251	1784581612	K050456	MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM	DXT	2005-06-17
130338	1453199958	K050380	XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A	IYN	2005-02-23
7743	1076822353	K042784	MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM	DXT	2004-12-10
38251	1076822353	K042784	MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM	DXT	2004-12-10
188736	1463413124	K042784	MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM	DXT	2004-12-10
7743	1308265950	K042569	8600 VITAL SIGNS MONITOR	MWI	2004-09-29
38251	1308265950	K042569	8600 VITAL SIGNS MONITOR	MWI	2004-09-29
130338	1461640223	K042368	PRACTIX CONVENIO	IZL	2004-10-04
130338	1884226940	K042023	FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER	MQB	2004-08-25
130338	1780355514	K041949	ALLURA XPER FD10	IZI	2004-07-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DXT	47	2026-02-13
JAK	13	2008-10-17
LNH	10	2013-11-15
BZQ	5	2018-05-07
IYN	5	2013-09-24
FRN	5	2010-06-23
OXO	4	2012-04-06
KPS	4	2008-06-12
IZL	4	2004-10-04
PDU	3	2025-09-11
IZQ	3	2024-11-05
LZA	3	2020-04-06
DYB	3	2015-09-22
FPK	3	2013-08-02
OWB	3	2012-08-16
MQB	3	2004-08-25
PQH	2	2020-07-30
GEI	2	2013-08-30
IZI	2	2013-05-21
MUE	2	2013-02-22
FPA	2	2009-06-05
GEH	2	2005-12-14
MWI	2	2004-09-29
HHS	2	2002-11-04
LYY	2	1998-11-30
EAG	2	1987-02-24
HAW	1	2025-09-04
DSA	1	2023-05-30
FXX	1	2021-12-07
NUH	1	2015-12-22
CBK	1	2014-04-08
OTE	1	2011-02-11
IYO	1	2009-08-21
LYZ	1	2007-02-08
HBB	1	2004-09-07
LMC	1	2004-01-09
DQX	1	2002-03-07
DXF	1	2001-02-01
IZH	1	1992-02-03
JAA	1	1990-11-06

NDC#

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)