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
88177–88200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1998
H-RAY
K982720 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 93d
Cleared Nov 05, 1998
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
K982821 · MUJ
Multimedia Medical Systems, Inc.
Radiology · 86d
Cleared Nov 05, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
K983151 · KXT
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Nov 05, 1998
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159 · DKB
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Nov 05, 1998
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K983287 · MKJ
Graphic Controls Corp.
Cardiovascular · 48d
Cleared Nov 05, 1998
VINYL EXAM GLOVES, POWDER FREE
K983494 · LYZ
Glormed Intl., Inc.
General Hospital · 31d
Cleared Nov 05, 1998
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM...
K983608 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 22d
Cleared Nov 05, 1998
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
K983612 · LYZ
Shanghai Jiatai Plastic Products Co.,...
General Hospital · 22d
Cleared Nov 04, 1998
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
K971616 · DQO
Data Sciences Intl., Inc.
Cardiovascular · 551d
Cleared Nov 04, 1998
BIO-2000
K973765 · EIA
Micrylium Laboratories
Dental · 398d
Cleared Nov 04, 1998
CANON X-RAY DIGITAL CAMERA CXDI-11
K981556 · MQB
Canon USA, Inc.
Radiology · 187d
Cleared Nov 04, 1998
SPIFE URINE IFE
K982639 · DAO
Helena Laboratories
Immunology · 98d
Cleared Nov 04, 1998
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
K982760 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Nov 04, 1998
QUANTA LITE H. PYLORI IGG ELISA
K982790 · LYR
Inova Diagnostics, Inc.
Microbiology · 86d
Cleared Nov 04, 1998
AUTO-LYTE PCP EIA, MODEL #1254U
K982801 · LCM
OraSure Technologies, Inc.
Toxicology · 86d
Cleared Nov 04, 1998
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · FRN
Sims Deltec, Inc.
General Hospital · 84d
Cleared Nov 04, 1998
DIGIRAD 2020TC SPECT IMAGING SYSTEM
K982855 · KPS
Digirad Corp.
Radiology · 90d
Cleared Nov 04, 1998
HELAX-IMCON, VERSION 1.0
K982857 · KPQ
Helax AB
Radiology · 83d
Cleared Nov 04, 1998
SILHOUETTE VR
K982955 · KPR
GE Medical Systems
Radiology · 72d
Cleared Nov 04, 1998
QUANTA LITE RF IGG ELISA
K983083 · DHR
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Nov 04, 1998
QUANTA LITE RF IGA ELISA
K983084 · DHR
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Nov 04, 1998
IGM
K983132 · DFT
Abbott Laboratories
Immunology · 57d
Cleared Nov 04, 1998
CT BIOPSYVIEW
K983140 · JAK
Philips Medical Systems North...
Radiology · 57d
Cleared Nov 04, 1998
TRF
K983167 · DDG
Abbott Laboratories
Immunology · 55d