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
89017–89040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1998
POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981878 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Aug 11, 1998
POWDERED NITRILE EXAMINATION GLOVES
K981879 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Aug 11, 1998
SELECTOR DIAGNOSTIC CATHETER
K982077 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 60d
Cleared Aug 11, 1998
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE
K982274 · LZA
Asia Pacific Latex Sdn Bhd
General Hospital · 43d
Cleared Aug 11, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K982286 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 42d
Cleared Aug 11, 1998
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
K982398 · JDC
Biomet, Inc.
Orthopedic · 32d
Cleared Aug 11, 1998
SCC-23 SAFETY CLAMP AND CUTTER
K982464 · KNA
Women First Healthcare, Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 11, 1998
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · OCT
Deroyal Industries, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 11, 1998
LATEX EXAMINATION GLOVES POWDER FREE
K982579 · LYY
Shiva Medicare , Ltd.
General Hospital · 18d
Cleared Aug 11, 1998
POWDER FREE SURGEONS GLOVE
K982586 · KGO
Shiva Medicare , Ltd.
General Hospital · 18d
Cleared Aug 10, 1998
IMMUNOWELL VCA IGM TEST
K973939 · LJN
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
IMMUNOWELL EBV VCA IGG TEST
K973940 · LSE
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
IMMUNOWELL EBNA IGG TEST
K973941 · LLM
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
DIGITAL DOC
K981663 · EIA
Digital Doc, LLC
Dental · 91d
Cleared Aug 10, 1998
PRINCE MEDICAL CEMENT PLUG
K981855 · JDI
Prince Medical, Inc.
Orthopedic · 76d
Cleared Aug 10, 1998
ESTENIA
K982164 · EBF
Kuraray America, Inc.
Dental · 52d
Cleared Aug 10, 1998
ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
K982201 · EBF
Foremost Dental Mfg., Inc.
Dental · 49d
Cleared Aug 10, 1998
HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
K982313 · FZP
Weck Closure Systems
General & Plastic Surgery · 40d
Cleared Aug 10, 1998
CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
K982415 · DRF
Cordis Webster, Inc.
Cardiovascular · 28d
Cleared Aug 10, 1998
AECD ARRHYTHMIA DETECTION SOFTWARE
K982710 · MKJ
Cardiac Science, Inc.
Cardiovascular · 6d
Cleared Aug 09, 1998
3M DENT II SYSTEM
K981647 · EBF
3M Company
Dental · 90d
Cleared Aug 07, 1998
CONTOR TABLE SURFACE
K973705 · DWJ
Hill-Rom, Inc.
Cardiovascular · 312d
Cleared Aug 07, 1998
INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE...
K974588 · IYN
Rimed , Ltd.
Radiology · 241d
Cleared Aug 07, 1998
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
K980016 · MOP
Genzyme Surgical Product (Genzyme...
Cardiovascular · 217d