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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79489–79512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 01, 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 8d
Cleared Feb 28, 2001
MAC ACUPUNCTURE NEEDLE
K002827 · MQX
Haenglim Seowon Corp.
General Hospital · 170d
Cleared Feb 28, 2001
VASCULAR ARCHITECTS PERISCOPE DEVICE
K003719 · DWX
Vascular Architects, Inc.
Cardiovascular · 86d
Cleared Feb 28, 2001
ALI 3D TOOL MODULE FOR MEDICAL IMAGES
K003762 · LLZ
A.L.I. Technologies, Inc.
Radiology · 84d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 82d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · DKZ
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · LTJ
Dade Behring, Inc.
Immunology · 68d
Cleared Feb 28, 2001
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
K010077 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Feb 28, 2001
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K010109 · MUW
Paragon Vision Sciences
Ophthalmic · 47d