Smith

FDA Filings

This page includes the latest FDA filings for Smith . Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Smith & Nephew, Inc.
HEALICOIL Knotless Suture Anchors2020-03-18
Smith & Nephew, Inc.
LEGION Inserts With JRNY Lock2020-03-13
Smith & Nephew, Inc.
CONQUEST FN2020-02-28
Smith & Nephew
INTELLIO Tablet Application2020-02-27
Smith & Nephew Medical Ltd.
IODOFLEX2019-12-20
Smith & Nephew Medical Ltd.
IODOSORB2019-12-20
Smith & Nephew Medical Limited
PICO 14 Single Use Negative Pressure Wound Therapy System2019-12-05
Smith & Nephew, Inc.
OR3O Dual Mobility System2019-10-31
Smith & Nephew, Inc.
REDAPT Blade Augments2019-10-25
Smiths Medical
Acapella Choice Blue Vibratory PEP Device2019-10-24
Smith & Nephew, Inc.
Smith & Nephew DYONICS 25 Fluid Management System2019-09-04
Smith And Nephew, Inc.
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head2019-08-23
Smith & Nephew, Inc.
JOURNEY II Unicompartmental Knee System2019-07-25
Smith & Nephew
Smith & Nephew Tablet Application2019-05-21
Smith & Nephew Medical Limited
RENASYS Touch; RENASYS Y-Connector2019-03-21
Smith And Nephew, Inc.
Double ENDOBUTTON Fixation Device2019-03-12
Smith & Nephew, Inc
EVOS Small Fragment Upper Extremity Plates Line Additions2019-03-11
Smith & Nephew Inc
Journey II Unicompartmental Knee System2019-02-11
Smith & Nephew Medical Limited
PICO 7Y Single Use Negative Pressure Wound Therapy System2019-01-18
Smith & Nephew Medical Limited
RENASYS Y-Connector; RENASYS TOUCH2019-01-10
Smith & Nephew, Inc.
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks2018-11-28
Smith & Nephew, Inc.
R3 Anteverted Liners2018-11-19
Smith & Nephew, Inc.
REDAPT Modular Acetabular Shell2018-11-16
Smith And Nephew, Inc.
MICRORAPTOR Knotless Suture Anchor2018-09-28
Smith & Nephew, Inc.
REDAPT Porous Acetabular Shell2018-09-24
Smith & Nephew Medical Limited
PICO 7 Single Use Negative Pressure Wound Therapy System2018-08-21
Smith & Nephew, Inc.
EVOS Wrist Fracture Plating System2018-08-09
Smiths Medical ASD, Inc.
Level 1 Convective Warmer2018-07-26
Smiths Medical ASD, Inc.
Portex® Lancet Point Spinal Needles With NRFit™ Connectors, Portex® Pencil Point Spinal Needles With NRFit™ Connectors2018-06-14
Smiths Medical ASD, Inc.
Portex NRFit Epidural Needles2018-06-12

Latest Premarket Applications

PMAManufacturerDevice NameDate
Smith & Nephew, Inc.
R3 delta Ceramic Acetabular System2019-06-07
Smith & Nephew, Inc.
R3 delta Ceramic Acetabular System2019-02-19
Smith & Nephew, Inc.
R3 delta Ceramic Acetabular System2018-12-07
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)2018-03-20
SMITH&NEPHEW ORTHOPAEDICS
Birmingham Hip Resurfacing (BHR) System2018-03-02
SMITH&NEPHEW ORTHOPAEDICS
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM2018-02-22
Smith & Nephew, Inc.
R3 DELTA Ceramic Hip System2017-12-20
Smith & Nephew, Inc.
REFLECTION Ceramic Acetabular Hip System2017-12-20
SMITH&NEPHEW ORTHOPAEDICS
Birmingham Hip Resurfacing System2017-12-20
Smith & Nephew, Inc.
R3 Delta Ceramic Acetabular System2017-11-30
Smith & Nephew, Inc.
RCHS Ceramic Liners and Shells2017-08-17
Smith & Nephew, Inc.
REFLECTION Ceramic Acetabular Hip System (RCHS)2017-06-02
Smith & Nephew, Inc.
R3 DELTA Ceramic Hip System2017-06-02
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR SYSTEM2017-01-12
SMITH&NEPHEW ORTHOPAEDICS
BIRMINGHAM HIP SYSTEM (BHR)2016-12-21
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)2016-12-21
Smith & Nephew, Inc.
R3 DELTA CERAMIC HIP SYSTEM2016-12-21
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR SYSTEM2016-12-08
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR SYSTEM2016-11-09
Smith & Nephew, Inc.
R3 DELTA CERAMIC HIP SYSTEM2016-10-17
Smith & Nephew, Inc.
REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS)2016-10-04
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR HIP SYSTEM2016-07-22
Smith & Nephew, Inc.
ANTHOLOGY FEMORAL STEMS2016-06-08
SMITH&NEPHEW ORTHOPAEDICS
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM2016-01-28
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)2016-01-28
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR HIPS SYSTEM (RCHS)2015-12-17
SMITH&NEPHEW ORTHOPAEDICS
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM2015-12-11
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)2015-09-25
SMITH&NEPHEW ORTHOPAEDICS
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM2015-08-10
Smith & Nephew, Inc.
R3 ACETABULAR SHELLS2014-10-17

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
TULA
Smith & Nephew, Inc.2020-04-01
InterTAN
Smith & Nephew, Inc.2020-04-01
InterTAN
Smith & Nephew, Inc.2020-04-01
Legion
Smith & Nephew, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-04-01
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
Bivona
Smiths Medical ASD, Inc.2020-03-31
INTELLIO LINK Dyonics Power II
Smith & Nephew, Inc.2020-03-30
INTEllIO LINK WEREWOLF
Smith & Nephew, Inc.2020-03-30

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