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
79993–80016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2001
HOMMED SENTRY III PATIENT MONITOR SYSTEM
K004044 · DQA
Hommed, LLC
Anesthesiology · 63d
Cleared Mar 02, 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
K010330 · DSP
Arrow Intl., Inc.
Cardiovascular · 28d
Cleared Mar 02, 2001
M2376A DEVICELINK SYSTEM
K010453 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Mar 01, 2001
PROFOX SOFTWARE, MODEL 920M-41
K001708 · DQA
Respironics Georgia, Inc.
Anesthesiology · 269d
Cleared Mar 01, 2001
LASER 4SPSC340
K003059 · INI
Pride Mobility Products Corp.
Physical Medicine · 150d
Cleared Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
K003328 · GIZ
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · GGC
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · DQK
Boston Scientific Corp
Cardiovascular · 125d
Cleared Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
K003411 · JIT
Roche Diagnostics Corp.
Chemistry · 119d
Cleared Mar 01, 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
K003705 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 90d
Cleared Mar 01, 2001
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL...
K003715 · GEX
Cooltouch Corp.
General & Plastic Surgery · 90d
Cleared Mar 01, 2001
INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE...
K003717 · GEI
Tekno Medical Optik-Chirurgie GmbH & Co.
General & Plastic Surgery · 87d
Cleared Mar 01, 2001
240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS
K003725 · IYO
Pie Medical
Radiology · 87d
Cleared Mar 01, 2001
TAKE 1
K003808 · ELW
Sybron Dental Specialties, Inc.
Dental · 83d
Cleared Mar 01, 2001
TI-REPLICA HIP STEM
K003875 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Mar 01, 2001
PALOMAR SPALIGHT PULSED LIGHT SYSTEM
K003886 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 73d
Cleared Mar 01, 2001
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL...
K003893 · HRX
Oratec Interventions, Inc.
Orthopedic · 73d
Cleared Mar 01, 2001
ENA EIA KIT RANGE
K010146 · LLL
The Binding Site, Ltd.
Immunology · 43d
Cleared Mar 01, 2001
ENA EIA KIT
K010147 · LLL
The Binding Site, Ltd.
Immunology · 43d
Cleared Mar 01, 2001
BD ECLIPSE HYPODERMIC NEEDLE
K010188 · FMI
Bd Medical Systems
General Hospital · 38d
Cleared Mar 01, 2001
CONTOUR PROFILE LASER
K010285 · GEX
Sciton, Inc
General & Plastic Surgery · 29d
Cleared Mar 01, 2001
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K010320 · LYC
Depuyacromed
Dental · 27d
Cleared Mar 01, 2001
LOGIQ 500
K010329 · IYN
General Electric Co.
Radiology · 27d
Cleared Mar 01, 2001
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
K010382 · CCL
Sensidyne, Inc.
Anesthesiology · 21d