FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94225–94248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1997
LINK CERCLAGE WIRE SYSTEM
K970084 · JDQ
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · JDW
Synthes (Usa)
Orthopedic · 59d
Cleared Mar 13, 1997
PERSONAL CATHETER
K970704 · GBM
Rochester Medical Corp.
Gastroenterology & Urology · 15d
Cleared Mar 12, 1997
CONTRAST MEDIA SET
K955179 · IZI
B.Braun Medical, Inc.
Radiology · 485d
Cleared Mar 12, 1997
MS-2000
K961144 · DXN
Touritu Engineering Co., Inc.
Cardiovascular · 356d
Cleared Mar 12, 1997
PROTIME MICROCOAGULATION SYSTEM
K961835 · GJS
International Technidyne Corp.
Hematology · 303d
Cleared Mar 12, 1997
HEARTPORT NEEDLE TROCAR
K965051 · DRC
Heartport, Inc.
Cardiovascular · 84d
Cleared Mar 12, 1997
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K965161 · LMD
Sectra-Imtec AB
Radiology · 79d
Cleared Mar 12, 1997
RFG-3CF
K965182 · GXD
Radionics, Inc.
Neurology · 78d
Cleared Mar 12, 1997
WIDEX MODEL SENSO DIGITAL (C9)
K965254 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 72d
Cleared Mar 12, 1997
TARGOGRID
K970037 · LNH
Daum GmbH
Radiology · 65d
Cleared Mar 12, 1997
INTEGRATED VISUALIZATION SYSTEM
K970598 · FCW
Urohealth, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 11, 1997
SLEEP SYSTEM FOR CLINICS & RESEARCH
K955841 · MNR
Compumedics Ptd , Ltd.
Anesthesiology · 445d
Cleared Mar 11, 1997
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
K961707 · BSY
Sorenson Critical Care
Anesthesiology · 313d
Cleared Mar 11, 1997
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
K962605 · FRG
Surgicot, Inc.
General Hospital · 252d
Cleared Mar 11, 1997
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K963001 · LPL
Permeable Technologies, Inc.
Ophthalmic · 221d
Cleared Mar 11, 1997
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
K963273 · KPS
Smv America
Radiology · 203d
Cleared Mar 11, 1997
VESSEL DILATOR
K963388 · DRE
Maxxim Medical
Cardiovascular · 195d
Cleared Mar 11, 1997
QUANTITATIVE SENTINEL SYSTEM
K963608 · HGM
Quantitative Medicine, Inc.
Obstetrics & Gynecology · 182d
Cleared Mar 11, 1997
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND...
K963787 · DRX
Conmedcorp
Cardiovascular · 172d
Cleared Mar 11, 1997
SMARTGUIDE
K963894 · FCG
Ferguson Medical
Gastroenterology & Urology · 165d
Cleared Mar 11, 1997
CYTOPLAST GBR
K964342 · LYC
Osteogenics Co.
Dental · 131d
Cleared Mar 11, 1997
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
K964474 · KGO
Allegiance Healthcare Corp.
General Hospital · 124d
Cleared Mar 11, 1997
FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM
K964636 · GEI
Valleylab, Inc.
General & Plastic Surgery · 112d