Medical Device Manufacturer · US , Mchenry , IL

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

529 submissions · 516 cleared · Since 1980
529
Total
516
Cleared
0
Denied
85 devices
26-50 of 85
Cleared Feb 22, 2008
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
K073466 · GEI
General & Plastic Surgery · 74d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · LPH
General & Plastic Surgery · 162d
Cleared Sep 18, 2007
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · GAT
General & Plastic Surgery · 29d
Cleared Aug 03, 2007
ALLEVYN AG DRESSING
K063835 · FRO
General & Plastic Surgery · 220d
Cleared Feb 22, 2007
560 HIGH DEFINITION CAMERA SYSTEM
K070266 · GCJ
General & Plastic Surgery · 24d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066 · LZO
General & Plastic Surgery · 88d
Cleared Apr 13, 2006
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
K060777 · GCJ
General & Plastic Surgery · 22d
Cleared Nov 23, 2005
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · GCJ
General & Plastic Surgery · 299d
Cleared Oct 21, 2005
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · GAT
General & Plastic Surgery · 25d
Cleared May 25, 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
K050898 · GEI
General & Plastic Surgery · 44d
Cleared Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · FRO
General & Plastic Surgery · 104d
Cleared Jul 27, 2004
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
K041328 · GEI
General & Plastic Surgery · 69d
Cleared Jun 07, 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · GAT
General & Plastic Surgery · 28d
Cleared Jun 04, 2004
DURABRAID SUTURE
K040789 · GAT
General & Plastic Surgery · 67d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · GEI
General & Plastic Surgery · 64d
Cleared Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · GCJ
General & Plastic Surgery · 28d
Cleared Jun 20, 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675 · GEI
General & Plastic Surgery · 21d
Cleared May 23, 2003
SAPHYRE BIPOLAR ABLATION PROBES
K031371 · GEI
General & Plastic Surgery · 23d
Cleared May 22, 2003
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
K031379 · GCJ
General & Plastic Surgery · 21d
Cleared Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
K023053 · GCJ
General & Plastic Surgery · 20d
Cleared Mar 12, 2002
RBM
K020480 · KGS
General & Plastic Surgery · 27d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · GEI
General & Plastic Surgery · 193d
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · GCJ
General & Plastic Surgery · 90d
Cleared Apr 10, 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · GCJ
General & Plastic Surgery · 49d
Cleared Oct 23, 2000
MR-III
K002261 · GAS
General & Plastic Surgery · 90d

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