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
92833–92856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1997
POTTY PAL AND FOREVER-DRY
K971855 · KPN
Digital Applications, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 18, 1997
EARCHECK
K971859 · ETY
Mdi Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared Aug 18, 1997
MEDISYSTEMS DIALYSIS PRIMING SETS
K971860 · KOC
Medisystems Corp.
Gastroenterology & Urology · 90d
Cleared Aug 18, 1997
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
K971874 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Aug 18, 1997
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM
K972029 · DZE
Bicon, Inc.
Dental · 77d
Cleared Aug 18, 1997
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
K972322 · JEY
Walter Lorenz Surgical, Inc.
Dental · 59d
Cleared Aug 18, 1997
V-DELTA 450
K972683 · EJS
Metalor Dental USA Corp.
Dental · 32d
Cleared Aug 15, 1997
MEDISYSTEMS PERITONEAL DIALYSIS SETS
K963668 · KDJ
Medisystems Corp.
Gastroenterology & Urology · 336d
Cleared Aug 15, 1997
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) &...
K964594 · KNF
Circon Corp.
Obstetrics & Gynecology · 273d
Cleared Aug 15, 1997
POWDER FREE LATEX EXAMINATION GLOVES
K970115 · LYY
Pt Mbf Buana Multicorpora
General Hospital · 214d
Cleared Aug 15, 1997
PRINTER INTERFACE
K970305 · DXH
Micromedical, Inc.
Cardiovascular · 200d
Cleared Aug 15, 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 198d
Cleared Aug 15, 1997
E-READER
K970436 · GZO
Natural Herbal Products, Inc.
Neurology · 191d
Cleared Aug 15, 1997
ENTERAL NUTRITION 1000 ML/500ML
K970849 · KNT
Medical Infusion Technologies, Inc.
Gastroenterology & Urology · 161d
Cleared Aug 15, 1997
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · KPQ
Varian Medical Systems, Inc.
Radiology · 88d
Cleared Aug 15, 1997
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
K971845 · ESD
Sound Hearing Instruments, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 15, 1997
TDK MEDICAL GRADE CD-R
K971848 · LMB
Tdk Electronics Corporation of America
Radiology · 88d
Cleared Aug 15, 1997
AIR CONDUCTION HAEARING AIDS
K971852 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 87d
Cleared Aug 15, 1997
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937 · OCY
Terumo Medical Corp.
Gastroenterology & Urology · 80d
Cleared Aug 15, 1997
PASCO MIC AND MIC/ID PANELS
K971951 · JWY
Pasco Laboratories, Inc.
Microbiology · 79d
Cleared Aug 15, 1997
OXLIFE EXCELL OXYGEN CONCENTRATORS
K971964 · CAW
Oxlife, Inc.
Anesthesiology · 79d
Cleared Aug 15, 1997
FULL BODY RESTRAINT SYSTEM
K972046 · FMQ
Gillen Industries
General Hospital · 74d
Cleared Aug 15, 1997
LORIPRO, LORIPRO II
K972058 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 74d
Cleared Aug 15, 1997
LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
K972104 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 72d