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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
144457–144480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1986
PRECINORM IM AND PRECIPATH IM
K860970 · JJY
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Apr 03, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K860998 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Apr 03, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Apr 03, 1986
ISOLIFE DISPENSING SYSTEM
K861051 · KNT
Navaco Laboratories
Gastroenterology & Urology · 15d
Cleared Apr 02, 1986
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
K853216 · HHK
Gyneco, Inc.
Obstetrics & Gynecology · 244d
Cleared Apr 02, 1986
ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE
K860246 · PUP
Buckman Co., Inc.
General Hospital · 68d
Cleared Apr 02, 1986
STABLELINE
K860298 · KRI
Cardio Metrics, Inc.
Cardiovascular · 64d
Cleared Apr 02, 1986
RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES
K860699 · DQY
Intracath, Inc.
Cardiovascular · 36d
Cleared Apr 02, 1986
ULTRAPROX, INTERPROXIMAL TOOTHBRUSH
K860779 · JET
William J. Forni, D.D.S.
Dental · 30d
Cleared Apr 02, 1986
PLASTIC MOUTH BARRIER HCV-E
K860780 · CAE
Westmark Enterprises, Inc.
Anesthesiology · 30d
Cleared Apr 02, 1986
TRACHEOBRONCHIAL SUCTION CATHETER
K860802 · BSY
Sheridan Catheter Corp.
Anesthesiology · 29d
Cleared Apr 02, 1986
VISTA INTERFACE SYSSTEM
K860844 · BZC
Vacumetrics, Inc.
Anesthesiology · 27d
Cleared Apr 02, 1986
DISPOSABLE HEATED WIRE LOOPS 48 AND 72
K860941 · BZE
Intec Medical, Inc.
Anesthesiology · 21d
Cleared Apr 02, 1986
CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
K861019 · EAK
Phase One Disign Co.
Radiology · 15d
Cleared Apr 02, 1986
BIOPSY ADAPTER H4222W
K861050 · GDF
General Electric Co.
General & Plastic Surgery · 14d
Cleared Apr 02, 1986
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 12d
Cleared Apr 01, 1986
HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS
K855150 · LKX
Hpk International, Inc.
Gastroenterology & Urology · 96d
Cleared Apr 01, 1986
MODULAR PRESS FIT (MPF) STEM
K855200 · JDI
Depuy, Inc.
Orthopedic · 95d
Cleared Apr 01, 1986
CONICAL COLLAR HIP PROSTHESIS POROUS COATED
K860002 · JDI
Kirschner Medical Corp.
Orthopedic · 89d
Cleared Apr 01, 1986
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
K860455 · BZQ
Oxford Medilog, Inc.
Anesthesiology · 55d
Cleared Apr 01, 1986
UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)
K860535 · CAT
Andover Medical, Inc.
Anesthesiology · 48d
Cleared Apr 01, 1986
ESOPHAGEAL STETHOSCOPE
K860558 · BZW
Sharn, Inc.
Anesthesiology · 46d
Cleared Apr 01, 1986
MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06
K860761 · LMC
Lenzar Optics Corp.
Radiology · 32d
Cleared Apr 01, 1986
SIREGRAPH D
K860913 · IXR
Siemens Medical Solutions USA, Inc.
Radiology · 21d