FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,107 results for "smith"
697–720 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Mar 01, 1999
PRE-THREADED ENDOBUTTON
K984550 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 69d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834 · LPH
Smith & Nephew, Inc.
Orthopedic · 117d
Cleared Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · HWC
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Dec 10, 1998
ALGISITE M
K983210 · KMF
Smith & Nephew, Inc.
General & Plastic Surgery · 87d
Cleared Dec 04, 1998
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942 · JDS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 10, 1998
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149 · HET
Smith & Nephew, Inc.
Obstetrics & Gynecology · 84d
Cleared Jul 31, 1998
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET...
K981713 · MGP
Smith & Nephew, Inc.
General & Plastic Surgery · 77d
Cleared Jul 17, 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · LZO
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · JDS
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jun 30, 1998
HAMMERSMITH ENDOCAVITARY COILS
K981410 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 71d
Cleared Jun 25, 1998
RADIO-PLAST
K981115 · LHN
Smith & Nephew, Inc.
Radiology · 90d
Cleared Jun 22, 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · MGQ
Smith & Nephew, Inc.
General & Plastic Surgery · 83d
Cleared May 20, 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156 · HRX
Smith & Nephew, Inc.
Orthopedic · 50d
Cleared May 20, 1998
RCI FIXATION SCREWS
K980841 · HWC
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared May 19, 1998
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 91d
Cleared May 07, 1998
CONTROLLED TEMPERATURE CABINET SYSTEM
K973747 · LDQ
Smith
General & Plastic Surgery · 218d
Cleared Apr 01, 1998
ENDOBUTTON CONTINUOUS LOOP
K980155 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Mar 10, 1998
TEMPO AND TEMP H20
K973748 · LGZ
Smith
General Hospital · 160d
Cleared Mar 09, 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · FRN
Smith & Nephew, Inc.
General Hospital · 59d
Cleared Jan 23, 1998
SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS...
K974767 · GCJ
Endoscopy Division
General & Plastic Surgery · 32d
Cleared Jan 20, 1998
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
K972385 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 208d
Cleared Jan 12, 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 34d
Cleared Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW...
K972979 · FBO
Smith & Nephew, Inc.
Gastroenterology & Urology · 122d
Cleared Nov 25, 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · KMF
Smith & Nephew, Inc.
General & Plastic Surgery · 90d