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
70921–70944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2003
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
K031948 · DXZ
Pm Devices, Inc.
Cardiovascular · 84d
Cleared Sep 16, 2003
VINTAGE AL
K032165 · EIH
Shofu Dental Corp.
Dental · 63d
Cleared Sep 16, 2003
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS...
K032529 · HRX
Hydrocision, Inc.
Orthopedic · 32d
Cleared Sep 16, 2003
MODIFICATION TO CONTOUR SE MICROSPHERES
K032542 · HCG
Boston Scientific Corp
Neurology · 29d
Cleared Sep 16, 2003
SHORT INTRODUCER SHEATH
K032569 · DYB
Rex Medical
Cardiovascular · 27d
Cleared Sep 16, 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 22d
Cleared Sep 16, 2003
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
K032674 · LGZ
Belmont Instrument Corp.
General Hospital · 18d
Cleared Sep 16, 2003
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · MWI
Nihon Kohden America, Inc.
Cardiovascular · 11d
Cleared Sep 15, 2003
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK...
K023837 · LAF
Princeton BioMeditech Corp.
Toxicology · 301d
Cleared Sep 15, 2003
SALINUM, ORCLAIR
K024148 · LFD
Sinclair Pharmaceuticals, Ltd.
Dental · 273d
Cleared Sep 15, 2003
3I DENTAL IMPLANTS
K030614 · DZE
Implant Innovations, Inc.
Dental · 201d
Cleared Sep 15, 2003
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · HAW
Biomet, Inc.
Neurology · 140d
Cleared Sep 15, 2003
FLUORIDE VARNISH
K031932 · LBH
Dentsply Intl.
Dental · 84d
Cleared Sep 15, 2003
ASAP ARTHROSCOPE MODELS
K031972 · HRX
Asap Endoscopic Products GmbH
Orthopedic · 81d
Cleared Sep 15, 2003
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
K031983 · NFB
Inovo, Inc.
Anesthesiology · 81d
Cleared Sep 15, 2003
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
K032054 · HAW
Radionics, A Division of Tyco...
Neurology · 75d
Cleared Sep 15, 2003
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
K032212 · HRX
Kyphon, Inc.
Orthopedic · 56d
Cleared Sep 15, 2003
PRISMA M60/M100 SETS
K032431 · KDI
Gambro, Inc.
Gastroenterology & Urology · 40d
Cleared Sep 15, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
K032518 · JWY
Bd Diagnostic Systems
Microbiology · 32d
Cleared Sep 15, 2003
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
K032566 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 25d
Cleared Sep 12, 2003
HANDYDOP
K030466 · KNG
Elcat, GmbH
Radiology · 212d
Cleared Sep 12, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522 · LPN
Ciba Vision Corporation
Ophthalmic · 205d
Cleared Sep 12, 2003
THERMOSKIN CONDUCTIVE PADS
K030564 · GXY
United Pacific, Inc.
Neurology · 203d
Cleared Sep 12, 2003
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
K030961 · LHD
Microlife Corp.
Obstetrics & Gynecology · 169d