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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93217–93240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL NASAL IMPLANTS
K971481 · FZE
Allied Biomedical Corp.
General & Plastic Surgery · 86d
Cleared Jul 18, 1997
REST MATTRESS
K971568 · FNM
Rest Mattress
General Hospital · 80d
Cleared Jul 18, 1997
CORDIS OPTA 5 PTA BALLOON CATHETER
K971579 · LIT
Cordis Corp.
Cardiovascular · 88d
Cleared Jul 18, 1997
HEMISPHERE CEMENTED CUP
K971581 · JDI
Ortho Development Corp.
Orthopedic · 79d
Cleared Jul 18, 1997
STERICHEK CHLORINE REAGENT STRIPS
K971598 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 18, 1997
SHARPLAN CO2 SURGICAL LASER SYSTEM
K971743 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 67d
Cleared Jul 18, 1997
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM
K971783 · HTY
Synthes (Usa)
Orthopedic · 65d
Cleared Jul 18, 1997
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · HSB
Biomet, Inc.
Orthopedic · 63d
Cleared Jul 18, 1997
BREATH ACE BREATHFRESHENER
K972131 · LCN
Beyond 21st Century, Inc.
Dental · 42d
Cleared Jul 17, 1997
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
K961719 · HRS
Howmedica Leibinger, Inc.
Orthopedic · 441d
Cleared Jul 17, 1997
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
K965123 · INI
Burke, Inc.
Physical Medicine · 244d
Cleared Jul 17, 1997
MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)
K970471 · LFL
Mentor Corp.
General & Plastic Surgery · 160d
Cleared Jul 17, 1997
P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)
K971189 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 107d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224 · GJT
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225 · GJT
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 17, 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418 · MOI
Chiron Diagnostics Corp.
Chemistry · 92d
Cleared Jul 17, 1997
SOMNOPLASTY SYSTEM
K971450 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jul 17, 1997
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755 · JEC
Howmedica Corp.
Orthopedic · 66d
Cleared Jul 17, 1997
CREATINE KINASE (CK)
K972155 · CGS
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 17, 1997
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K972297 · JFJ
Trace America, Inc.
Chemistry · 28d
Cleared Jul 16, 1997
NEEDLE-FREE VALVED CONNECTOR AND CAP
K964439 · FPA
Bmw Medical, Inc.
General Hospital · 252d
Cleared Jul 16, 1997
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
K964821 · DQA
Ventrex, Inc.
Anesthesiology · 226d
Cleared Jul 16, 1997
OXIMETER PRE-AMP CABLE
K965172 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 204d
Cleared Jul 16, 1997
SCT 3000 HEATED HUMIDIFIER
K970478 · BTT
Marquest Medical Products, Inc.
Anesthesiology · 159d