Medical Device Manufacturer · US , Mchenry , IL

Smith & Nephew, Inc. - FDA 510(k) Cleared Devices

530 submissions · 517 cleared · Since 1980
530
Total
517
Cleared
0
Denied
530 devices
401-425 of 530
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · JWH
Orthopedic · 61d
Cleared Aug 19, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · HAW
Neurology · 24d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Orthopedic · 364d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Orthopedic · 21d
Cleared Apr 17, 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · FRN
General Hospital · 23d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · HWC
Orthopedic · 68d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012778 · JWH
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012787 · LPH
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE...
K012788 · KWS
Orthopedic · 207d
Cleared Mar 12, 2002
RBM
K020480 · KGS
General & Plastic Surgery · 27d
Cleared Feb 08, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · HAW
Neurology · 161d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · GEI
General & Plastic Surgery · 193d
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · HIH
Obstetrics & Gynecology · 57d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Orthopedic · 15d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Orthopedic · 140d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · LPH
Orthopedic · 29d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · LYK
Cardiovascular · 86d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · MAI
Orthopedic · 129d
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · GCJ
General & Plastic Surgery · 90d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · MAI
Orthopedic · 58d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596 · IPF
Physical Medicine · 197d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · MQV
Orthopedic · 88d
Cleared Apr 10, 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · GCJ
General & Plastic Surgery · 49d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · HWC
Orthopedic · 224d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572 · HRX
Orthopedic · 87d

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