SMI

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

NDC#

• Oxygen

  Smith's Home Medical Equipment, Inc.

  Oxygen

• COLLAGENASE SANTYL

  SMITH & NEPHEW, INC

  COLLAGENASE SANTYL

• OXYGEN

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

  OXYGEN

• I.V. Prep Antiseptic Wipe

  Smith & Nephew, Medical Ltd

  ISOPROPYL ALCOHOL

• Secura Moisturizing Cleanser

  Smith & Nephew Medical Ltd

  BENZETHONIUM CHLORIDE

• Secura Protective

  Smith & Nephew Medical Ltd

  ZINC OXIDE

• Secura Protective

  Smith & Nephew Medical Ltd

  ZINC OXIDE

• Secura Protective

  Smith & Nephew Medical Ltd

  petrolatum

• Secura Protective

  Smith & Nephew Medical Ltd

  petrolatum

• Secura Dimethicone Protectant

  Smith & Nephew Medical Ltd

  DIMETHICONE

• Secura Extra Protective

  Smith & Nephew Medical Ltd

  ZINC OXIDE

• Secura Extra Protective Cream

  Smith & Nephew Medical Ltd

  ZINC OXIDE

• Secura Antifungal

  Smith & Nephew Medical Ltd

  MICONAZOLE NITRATE

• Secura Antifungal

  Smith & Nephew Medical Ltd

  MICONAZOLE NITRATE

• Dermal Wound Cleanser

  Smith & Nephew Medical Ltd.

  BENZETHONIUM CHLORIDE

• Dermal Wound Cleanser

  Smith & Nephew Medical Ltd.

  BENZETHONIUM CHLORIDE

• Joint Ease

  Smith Amish, LLC

  MENTHOL

• ARTHRITIS

  Smith Amish, LLC

  MENTHOL

• 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...

• R3 Delta Ceramic Hip System

  2021-12-20

  Smith & Nephew, Inc.

• R3 DELTA CERAMIC HIP SYSTEM

  2021-12-08

  Smith & Nephew, Inc.

• R3 DELTA CERAMIC HIP SYSTEM

  2021-11-09

  Smith & Nephew, Inc.

• R3 Delta Ceramic Acetabular System

  2021-06-30

  Smith & Nephew, Inc.

• R3 Delta Ceramic Hip System

  2021-06-30

  Smith & Nephew, Inc.

• R3 Delta Ceramic Acetabular System

  2021-06-29

  Smith & Nephew, Inc.

• R3 Biolox delta Ceramic Acetabular System

  2020-08-21

  Smith & Nephew, Inc.

• R3 delta Ceramic Acetabular System

  2019-06-07

  Smith & Nephew, Inc.

• R3 delta Ceramic Acetabular System

  2019-02-19

  Smith & Nephew, Inc.

• R3 delta Ceramic Acetabular System

  2018-12-07

  Smith & Nephew, Inc.

• REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)

  2018-03-20

  Smith & Nephew, Inc.

• Birmingham Hip Resurfacing (BHR) System

  2018-03-02

  SMITH&NEPHEW ORTHOPAEDICS

• BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

  2018-02-22

  SMITH&NEPHEW ORTHOPAEDICS

• R3 DELTA Ceramic Hip System

  2017-12-20

  Smith & Nephew, Inc.

• REFLECTION Ceramic Acetabular Hip System

  2017-12-20

  Smith & Nephew, Inc.

• Birmingham Hip Resurfacing System

  2017-12-20

  SMITH&NEPHEW ORTHOPAEDICS

• R3 Delta Ceramic Acetabular System

  2017-11-30

  Smith & Nephew, Inc.

• RCHS Ceramic Liners and Shells

  2017-08-17

  Smith & Nephew, Inc.

• R3 DELTA Ceramic Hip System

  2017-06-02

  Smith & Nephew, Inc.

• REFLECTION Ceramic Acetabular Hip System (RCHS)

  2017-06-02

  Smith & Nephew, Inc.

• REFLECTION CERAMIC ACETABULAR SYSTEM

  2017-01-12

  Smith & Nephew, Inc.

• R3 DELTA CERAMIC HIP SYSTEM

  2016-12-21

  Smith & Nephew, Inc.

• REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)

  2016-12-21

  Smith & Nephew, Inc.

• BIRMINGHAM HIP SYSTEM (BHR)

  2016-12-21

  SMITH&NEPHEW ORTHOPAEDICS

• REFLECTION CERAMIC ACETABULAR SYSTEM

  2016-12-08

  Smith & Nephew, Inc.

• REFLECTION CERAMIC ACETABULAR SYSTEM

  2016-11-09

  Smith & Nephew, Inc.

147 records. Showing 1-40. Next

PMN#

• AETOS Shoulder System Meta Humeral Prosthesis Size 0

  2025-10-29

  Smith & Nephew, Inc.

• RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

  2025-09-11

  Smith & Nephew Medical, Ltd.

• TRIGEN Stable Lock Nut & Washer

  2025-06-12

  Smith & Nephew, Inc.

• LEGION Total Knee System

  2025-04-02

  Smith & Nephew, Inc.

• EVOS Pelvic and Acetabular System

  2025-02-19

  Smith & Nephew

• BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

  2024-12-17

  Smith & Nephew Medical Limited

• TRIGEN META-TAN Trochanteric Antegrade Nail

  2024-12-09

  Smith & Nephew, Inc.

• REGENETEN? Bioinductive Implant

  2024-11-26

  Smith & Nephew Inc., Endoscopy Div.

• AETOS Shoulder System Stemless Humeral Prosthesis

  2024-11-20

  Smith & Nephew, Inc.

• JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

  2024-10-30

  Smith & Nephew, Inc.

• Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

  2024-10-21

  Smith & Nephew, Inc.

• OR3O Dual Mobility System

  2024-10-07

  Smith & Nephew, Inc.

• TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

  2024-09-20

  Smith & Nephew, Inc.

• EVOS Patella Plates

  2024-09-03

  Smith & Nephew

• TRIGEN INTERTAN 10S Nail System

  2024-08-22

  Smith & Nephew, Inc.

• CATALYSTEM Femoral Stems

  2024-06-27

  Smith & Nephew, Inc.

• Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless

  2024-06-20

  Smith & Nephew, Inc.

• Hypodermic Needle-Pro® EDGE? Safety Device with Low Dead Space Syringe

  2024-05-31

  Smiths Medical Asd, Inc.

• Renasys Edge

  2024-05-24

  Smith & Nephew Medical, Ltd.

• CORIOGRAPH Knee Pre-Op Plan

  2024-03-18

  Smith & Nephew, Inc.

• ACCORD Cable System

  2024-03-13

  Smith & Nephew, Inc.

• Footprint Mini PK, 3.5mm Suture Anchor

  2024-01-17

  Smith & Nephew

• Cannulated Screw System

  2023-12-21

  Smith & Nephew, Inc.

• OR3O Dual Mobility Liners

  2023-10-27

  Smith & Nephew, Inc.

• Smileyscope System (Therapy Mode)

  2023-09-25

  Smileyscope Holding, Inc.

• Q-FIX ULTRA All-Suture Anchor

  2023-09-08

  Smith & Nephew

• ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesiv

  2023-08-18

  Smith & Nephew Medical Limited

• Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)

  2023-08-09

  Smith & Nephew, Inc.

• HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)

  2023-08-04

  Smith & Nephew, Inc.

• TANDEM Hip System

  2023-07-19

  Smith & Nephew, Inc.

• TRIGEN META-NAIL Nail System

  2023-06-14

  Smith & Nephew, Inc.

• AETOS Shoulder System

  2023-06-07

  Smith & Nephew, Inc.

• Smith & Nephew ACCORD? Cable System

  2023-05-30

  Smith & Nephew

• VERSAJET Hydrosurgery System (III)

  2023-05-16

  Smith & Nephew Medical Limited

• Regeneten Bioinductive Implant

  2023-05-11

  Smith and Nephew, Inc.

• Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ Sy

  2023-05-04

  Smith & Nephew, Inc.

• Cemented Tibia Baseplate no Taper with JRNY Lock

  2023-03-30

  Smith & Nephew, Inc.

• ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device

  2023-02-17

  Smith & Nephew, Inc.

• RENASYS?-WF White Foam NPWT Dressing Small; RENASYS?-WF White Foam NPWT Dressing Large

  2023-02-10

  Smith and Nephew Medical Limited

• AETOS Shoulder System

  2023-01-03

  Smith & Nephew, Inc.

200 records. Showing 1-40. Next

Applications#

• 103691

  SMITH AND NEPHEW

• 101995

  SMITH AND NEPHEW

• 089434

  SMITH AND NEPHEW

• 089251

  SMITH AND NEPHEW

• 089043

  SMITH AND NEPHEW

• 088960

  SMITH AND NEPHEW

• 088767

  SMITH AND NEPHEW

• 088766

  SMITH AND NEPHEW

• 088749

  SMITH AND NEPHEW

• 088581

  SMITH AND NEPHEW

• 088580

  SMITH AND NEPHEW

• 088531

  SMITH AND NEPHEW

• 088530

  SMITH AND NEPHEW

• 088521

  SMITH AND NEPHEW

• 088519

  SMITH AND NEPHEW

• 088518

  SMITH AND NEPHEW

• 088460

  SMITH AND NEPHEW

• 088458

  SMITH AND NEPHEW

• 088429

  SMITH AND NEPHEW

• 088239

  SMITH AND NEPHEW

• 087959

  SMITH AND NEPHEW

• 087958

  SMITH AND NEPHEW

• 087906

  SMITH AND NEPHEW

• 087904

  SMITH AND NEPHEW

• 087592

  SMITH AND NEPHEW

• 083900

  SMITH KLINE & FRENCH

• 071750

  SMITH AND NEPHEW

• 071682

  SMITH AND NEPHEW

• 071681

  SMITH AND NEPHEW

• 071671

  SMITH AND NEPHEW

• 070841

  SMITH AND NEPHEW

• 070802

  SMITH AND NEPHEW

• 070697

  SMITH AND NEPHEW

• 070696

  SMITH AND NEPHEW

• 070634

  SMITH AND NEPHEW

• 070633

  SMITH AND NEPHEW

• 070623

  SMITH AND NEPHEW

• 070622

  SMITH AND NEPHEW

• 070137

  SMITH AND NEPHEW

• 070135

  SMITH AND NEPHEW

52 records. Showing 1-40. Next