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
88441–88464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1998
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
K982688 · MIB
Spectrum Designs, Inc.
General & Plastic Surgery · 71d
Cleared Oct 13, 1998
DRUG CALIBRATOR II
K982871 · DKB
Dade Behring, Inc.
Toxicology · 60d
Cleared Oct 13, 1998
BTF THIN FILM WOUND DRESSING
K982939 · MGP
Bioderm, Inc.
General & Plastic Surgery · 53d
Cleared Oct 13, 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982 · HRS
Biomet, Inc.
Orthopedic · 48d
Cleared Oct 13, 1998
INNOVASIVE TIBIAL FASTENER
K983056 · MBI
Innovasive Devices, Inc.
Orthopedic · 42d
Cleared Oct 13, 1998
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
K983175 · LYY
Ultrawin Sdn Bhd
General Hospital · 33d
Cleared Oct 09, 1998
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
K981323 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 179d
Cleared Oct 09, 1998
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
K981591 · FAD
International Regulatory Consultants
Gastroenterology & Urology · 158d
Cleared Oct 09, 1998
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY
K981597 · IYE
Radionics, Inc.
Radiology · 158d
Cleared Oct 09, 1998
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
K982412 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 88d
Cleared Oct 09, 1998
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
K982428 · HET
Innervision, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 09, 1998
CCA-220
K982441 · EWO
Benson Medical Instruments Co.
Ear, Nose, Throat · 87d
Cleared Oct 09, 1998
DISPOSABLE VINYL EXAM GLOVES, POWDERED
K982687 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 67d
Cleared Oct 09, 1998
MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K982691 · LYY
Perusahaan Intan Emas Sdn. Bhd.
General Hospital · 67d
Cleared Oct 09, 1998
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814 · DXT
Medrad, Inc.
Cardiovascular · 59d
Cleared Oct 09, 1998
STERNOMEGA COMPOMER CEMENT
K982895 · EMA
Sterngold/Implamed
Dental · 53d
Cleared Oct 09, 1998
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS -...
K983162 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 29d
Cleared Oct 09, 1998
CENTAURI
K983211 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 25d
Cleared Oct 09, 1998
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
K983327 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Oct 09, 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387 · DIF
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared Oct 09, 1998
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
K983492 · JJY
Boehringer Mannheim Corp.
Chemistry · 4d
Cleared Oct 08, 1998
ULTRACAM
K973410 · EIA
W. Edward Johansen
Dental · 394d
Cleared Oct 08, 1998
MILLENNIUM
K980585 · EFB
Biolase Technology, Inc.
Dental · 233d
Cleared Oct 08, 1998
AIA-PACK TPOAB ASSAY
K981521 · JZO
Tosoh Medics, Inc.
Immunology · 163d