FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,136 results for "smith"
793–816 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Nov 06, 1996
FLEXSURE OBT
K961062 · KHE
Smithkline Diagnostics, Inc.
Hematology · 233d
Cleared Nov 04, 1996
ELECTROSURGICAL PROBE
K963901 · GEI
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 38d
Cleared Oct 25, 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 77d
Cleared Oct 21, 1996
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
K962931 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 84d
Cleared Oct 18, 1996
SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
K963570 · FMJ
Smiths Industries Medical Systems, Inc.
General Hospital · 43d
Cleared Oct 02, 1996
ULTIUM SPINAL PLATING SYSTEM
K962784 · MNH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 77d
Cleared Sep 23, 1996
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
K962462 · IPF
Smith and Nephew Donjoy, Inc.
Physical Medicine · 90d
Cleared Sep 17, 1996
REFLECTION ACETABULAR REINFORCEMENT RINGS
K962541 · JDJ
Smith & Nephew Richards, Inc.
Orthopedic · 81d
Cleared Aug 30, 1996
ROBISON & SMITH SURGICAL PACKS
K955586 · FYA
Robison & Smith, Inc.
General Hospital · 267d
Cleared Aug 19, 1996
ILIZAROV EXTERNAL FIXATION SYSTEM
K962808 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 32d
Cleared Aug 14, 1996
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
K962789 · GEY
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 28d
Cleared Aug 02, 1996
GENESIS II CONSTRAINED SYSTEM
K962137 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 60d
Cleared Jul 16, 1996
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · EFQ
Smith & Nephew United, Inc.
General & Plastic Surgery · 69d
Cleared Jul 16, 1996
ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
K961649 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 77d
Cleared Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT...
K960183 · LYR
Smithkline Diagnostics, Inc.
Microbiology · 143d
Cleared May 08, 1996
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830 · LKP
Orgentec
Immunology · 201d
Cleared May 02, 1996
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP....
K960429 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 92d
Cleared Apr 08, 1996
COFIED MODULAR SHOULDER SYSTEM
K955767 · KWS
Smith & Nephew Richards, Inc.
Orthopedic · 109d
Cleared Apr 05, 1996
SMITH S-100 TIME & TEMPERATURE CONTROL
K955825 · EGY
Smith Companies Dental Products
Radiology · 101d
Cleared Mar 27, 1996
REFLECTION DUAL DIMENSION SHELL
K960094 · MBL
Smith & Nephew Richards, Inc.
Orthopedic · 76d
Cleared Mar 11, 1996
ROGOZINSKI THORACOLUMBAR SPINAL ROD
K954696 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Mar 08, 1996
MODEL 1100 COLD THERAPY DEVICE
K955057 · ILO
Smith and Nephew Donjoy, Inc.
Physical Medicine · 123d
Cleared Feb 26, 1996
VENTILATION TUBES
K960477 · ETD
Smith & Nephew, Inc.
Ear, Nose, Throat · 25d
Cleared Feb 08, 1996
LIMITED REUSE ARTHROSCOPIC BLADES
K955914 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 55d