FDA.reportPublic FDA data

SMI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
SMILECAD5N2026-01-01104-1 Myeongnyun-ro Dongnae-gu Busan KR 47814
10202791020279SMITH & NEPHEW, INC.1N2026-01-011450 BROOKS RD. MEMPHIS TN US 38116
10671353002529679SMILE MAKERS, INC.1Y2026-01-01294 John Martin Road SPARTANBURG SC US 29303
12196021219602SMITH & NEPHEW INC.1N2026-01-01ENDOSCOPY 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD. MANSFIELD MA US 02048
15276161527616SMITHERS MEDICAL PRODUCTS, INC.1N2026-01-014850 HOSSLER DRIVE NW North Canton OH US 44720
16432641643264SMITH & NEPHEW INC.1Y2026-01-01ENDOSCOPY 76 S. MERIDIAN AVE. OKLAHOMA CITY OK US 73107
21835762183576SMI DIV. OF SOHN MFG., INC.1N2026-01-01544 Sohn Dr ELKHART LAKE WI US 53020
30228083022808SMITH SPORT OPTICS, INC.1Y2026-01-01Freeport Center, Building F-13 Clearfield UT US 84016
96133693002807893SMITH & NEPHEW ORTHOPAEDICS AG1N2026-01-01SCHACHENALLEE 29 DAMMWEG 39 AARAU Aargau CH CH-5001
30036040533003604053SMITH & NEPHEW INC.1N2026-01-01ENDOSCOPY 150 Minuteman Rd ANDOVER MA US 01810
30039666403003966640SMILE EYES INC1Y2026-01-01385 Pearsall Ave 6 Cedarhurst NY US 11516
30055516263005551626SMITH & NEPHEW, INC.1N2026-01-016409 E Holmes Rd Memphis TN US 38141
30057304063005730406SMITHWORKS, INC.1N2026-01-0113626 FM 2710 Lindale TX US 75771
30061580883006158088SMISSON-CARTLEDGE BIOMEDICAL LLC1N2026-01-01487 Cherry Street Third Street Tower Macon GA US 31201
30073667903007282753Smith & Nephew, Inc.1Y2026-01-013303 E Holmes Rd Memphis TN US 38118
30076061163007606116Smith Associates Imports1Y2026-01-011468 Harwell Ave Crofton MD US 21114
30087440623008744062Smith & Nephew, Inc.1N2026-01-017135 Goodlett Farms Pkwy Cordova TN US 38016
30100347803010034780Smith & Nephew, Inc.1Y2026-01-012225 Cedars Rd Ste A Lawrenceville GA US 30043
30106054773010605477SMIRTHWAITE LTD1N2026-01-0116 Wentworth Road Heathfield Newton Abbot Devon GB TQ212 6TL
30145278993014527899SMI COLD THERAPY LLC. DBA SOLUTION MATRIX1N2026-01-0160 Commerce Rd Rocky Mount VA US 24151
30155150183015515018Smit Patel1N2026-01-01802 S Coppell Road Coppell, Texas Coppell TX US 75019
30186888973018688897SMILE SOLUTIONS DENTAL LABORATORY INC1Y2026-01-016000 PARK OF COMMERCE BLVD STE B Boca Raton FL US 33487
30199441633019944163SMILECONCEPT DENTAL LAB1N2026-01-01A dong 17 Floor 1711ho Hyundai Knowledge Industry Center 70, Du Seoul KR 08584
30304080623030408062SMILEY DENTAL LABS SOLUTIONS1Y2026-01-01170 Nw 70th St Apt 204 Boca Raton FL US 33487
30385039323038503932Smith & Nephew, Inc.1N2026-01-014340 Swinnea Rd Memphis TN US 38118

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
551345256376P150030R3 DELTA CERAMIC HIP SYSTEMMRA2016-10-17
1257551345256376P150030R3 DELTA CERAMIC HIP SYSTEMMRA2016-10-17
551377026204P030022REFLECTION CERAMIC ACETABULAR SYSTEMMRA2004-12-17
1257551377026204P030022REFLECTION CERAMIC ACETABULAR SYSTEMMRA2004-12-17
551607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
980011607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
1257551607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
3401451607622273K994350NEER III TOTAL SHOULDER SYSTEMKWS2000-05-23
1491311255819360K994202ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEMHWC2000-02-25
1491351255819360K994202ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEMHWC2000-02-25
551005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
980011005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
1257551005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
1491341005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
3401451005360707K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]JDW2000-02-18
1482251041139062K994126MODULAR-PLUS REVISION STEMLWJ2000-05-04
1491342038381725K994084SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIESFFS2000-01-20
1491352038381725K994084SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIESFFS2000-01-20
1491351012512262K993967ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002GEI1999-12-17
1491341458512983K993854ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIESGEI1999-12-06
1491341153261348K993535METAPAK MULTI-PURPOSE INSTRUMENT TRAYFRG2001-12-07
1491351153261348K993535METAPAK MULTI-PURPOSE INSTRUMENT TRAYFRG2001-12-07
551974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
980011974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
1257551974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
3401451974574317K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
3401451143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
551143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
980011143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
1257551143492620K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)HRS1999-12-09
1491311905238536K992945RCI FIXATION SCREWS (WITH ASSORTED SIZES)HWC1999-11-18
1491351905238536K992945RCI FIXATION SCREWS (WITH ASSORTED SIZES)HWC1999-11-18
1491311298661010K992938ROTORBLADE SUTURE ANCHORMAI1999-09-23
1491312062320165K992396BIORCI SCREWHWC2000-01-12
1491352062320165K992396BIORCI SCREWHWC2000-01-12
551785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
980011785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
1257551785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
3401451785751982K992220RADIAL HEAD PROSTHESISKWI2000-02-25
1491341857467400K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESHRX1999-08-06
551808812632K991538OPERA CUPFLANGED ACETABULAR COMPONENTSJDI1999-06-03
980011808812632K991538OPERA CUPFLANGED ACETABULAR COMPONENTSJDI1999-06-03
1257551808812632K991538OPERA CUPFLANGED ACETABULAR COMPONENTSJDI1999-06-03
551818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
980011818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
1257551818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
3401451818210685K991485SYNERGY POROUS SIZE 8 HIP STEMLPH1999-07-12
1514781373223876K991383HYDROCISION DEBDRIDEMENT SYSTEMFQH2000-03-31
1491341138249055K991323SMITH & NEPHEW SUBCUTANEOUS ILLUMINATORFFS1999-07-06
1491341289235775K991218ORATEC BIPOLAR ABLATION PROBESGEI1999-09-13
1491351289235775K991218ORATEC BIPOLAR ABLATION PROBESGEI1999-09-13
551989901421K991162BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO2000-01-28
980011989901421K991162BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO2000-01-28
1257551989901421K991162BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO2000-01-28
1491342029230715K991140ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIESGEI1999-10-25
1491352029230715K991140ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIESGEI1999-10-25
551803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
980011803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
1257551803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
3401451803429688K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTSLPH1999-10-22
1491341327337833K990859DEFLECTABLE TAC ELECTROTHERMAL PROBEGEI1999-06-14
1491351327337833K990859DEFLECTABLE TAC ELECTROTHERMAL PROBEGEI1999-06-14
1491341375770021K990723DYONICS VARICOSE VEIN ABLATION BLADEGEI1999-10-05
1491351375770021K990723DYONICS VARICOSE VEIN ABLATION BLADEGEI1999-10-05
551270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
980011270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
1257551270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
3401451270696644K990666HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLMEH1999-08-06
1491311327625978K990414SMITH & NEPHEW HANDPORT SYSTEMGCJ1999-04-14
551100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
980011100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
1257551100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
3401451100766499K990369SYNERGY CEMENTED HIP STEMJDI1999-03-12
1491311266598328K984320BIOABSORBABLE INTERFERENCE SCREWSHWC1999-01-28
551926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
980011926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
1257551926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
3401451926793132K983942INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAPJDS1998-12-04
3401451298239724K983834ECHELON HIP STEMLPH1999-02-24
551298239724K983834ECHELON HIP STEMLPH1999-02-24
980011298239724K983834ECHELON HIP STEMLPH1999-02-24
1257551298239724K983834ECHELON HIP STEMLPH1999-02-24
1491311943704214K982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONJDI1998-11-20
1491341965919102K982149SMITH & NEPHEW DYONICS MICROLAPAROSCOPEHET1998-09-10
551741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
980011741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
1257551741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
3401451741822189K981847BIOLOX ALUMINA CERAMIC FEMORAL HEADLZO1998-07-17
1514781966265438K981713CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0MGP1998-07-31
3401451390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
551390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
980011390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
1257551390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
1491341390826652K981529TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWJDS1998-07-09
1491311342182902K981156DYONICS INTELIJET INFLOW/OUTFLOW CANNULAHRX1998-05-20
1491352032968251K980604SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIESGCJ1998-05-19
1491311740962577K980155ENDOBUTTON CONTINUOUS LOOPGAT1998-04-01
1491351740962577K980155ENDOBUTTON CONTINUOUS LOOPGAT1998-04-01
1491311568176385K980092SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULASFRN1998-03-09
1514781558257663K973228STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)KMF1997-11-25
1491311616162045K972599ACUFEX SCREW CANNULAHWC1997-09-19
1491351616162045K972599ACUFEX SCREW CANNULAHWC1997-09-19
1491341824693926K972471DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIESGCJ1997-10-24
1491311024767135K972326PEBA ANCHOR/SUTURE COMBINATIONMBI1998-02-06
1491351024767135K972326PEBA ANCHOR/SUTURE COMBINATIONMBI1998-02-06
551646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
980011646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
1257551646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
3401451646671095K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSLZO1997-07-16
1491351032304183K971253VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTSHRX1997-06-13
1491311708433823K970949SMITH & NEPHEW MIS INSTRUMENTSGCJ1997-04-23
551234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
980011234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
1257551234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
3401451234497942K970751HEIDELBERG EXTERNAL FIXATORJDW1997-04-16
3401451252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
551252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
980011252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09
1257551252115402K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMKTT1997-05-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH2142025-04-02
HRS1402025-02-19
LPH1282024-10-07
MBI942025-06-25
HWC862014-05-15
JDI802024-10-21
KTT772021-07-29
LZO702025-03-28
HRX702020-07-20
HSX562024-10-30
MEH542017-05-01
OLO512026-03-26
HSB502024-12-09
GEI492023-12-11
MBH412021-10-01
MBL402020-10-06
JDW392022-12-08
GAT392021-02-01
JDS382025-06-12
GCJ312022-10-20
KWS282026-04-06
MAI272020-03-18
KWZ252017-06-19
HAW212008-07-18
NPJ192009-12-15
JDO182022-09-29
OMP162016-08-04
KCT162013-03-11
JDQ112024-03-13
HTN102019-03-12
KRO92015-07-28
LZY82023-07-19
LOD82015-03-05
HSD82012-09-07
KWY82003-01-23
KWL81994-04-25
JDR72008-11-03
ODA62022-09-06
HWQ61993-05-05
FQH52011-08-01

NDC#

Oxygen

Smith's Home Medical Equipment, Inc.

Oxygen

OXYGEN

Smith's Drugs fo Forest City, Inc. dba Smith Drugs

OXYGEN

FOOT

Smith Amish, LLC

MENTHOL

ECZEMA

Smith Amish, LLC

COLLOIDAL OATMEAL

PMA#

R3™ DELTA CERAMIC ACETABULAR SYSTEM

2022-11-18

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS028 Date Received10/25/2022 Decision Date11/18/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 DELTA CERAMIC ACETABULAR SYSTEM

2022-09-29

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS027 Date Received08/31/2022 Decision Date09/29/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Acetabular System

2022-09-21

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS026 Date Received08/23/2022 Decision Date09/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Acetabular System

2022-09-13

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS025 Date Received08/16/2022 Decision Date09/13/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Hip System

2022-09-01

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS024 Date Received08/05/2022 Decision Date09/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3TM Delta Ceramic Acetabular System

2022-08-08

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS023 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

Reflection Ceramic Hip System

2022-08-08

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS049 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

Reflection Ceramic Acetabular Hip System

2022-07-05

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS048 Date Received06/06/2022 Decision Date07/05/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

Reflection Ceramic Hip System

2022-06-21

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS047 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

R3 Delta Ceramic Acetabular System

2022-06-21

Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS022 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Man...

Birmingham Hip Resurfacing (BHR) System

2022-05-19

SMITH&NEPHEW ORTHOPAEDICS7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP040033 Supplement NumberS036 Date Received04/22/2022 Decision Date05/19/2022 Product Code NXT  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Proc...

R3 Delta Ceramic Hip System, Reflection Ceramic Hip System

2022-05-17

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS021 Date Received04/29/2022 Decision Date05/17/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3™ Delta Ceramic Acetabular System

2022-05-03

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS020 Date Received04/06/2022 Decision Date05/03/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

R3 Delta Ceramic Hip System

2022-04-01

Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS019 Date Received03/07/2022 Decision Date04/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process C...

147 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

Applications#

52 records. Showing 1-40. Next