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
72457–72480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · DLJ
Microgenics Corp.
Toxicology · 90d
Cleared Feb 10, 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Feb 10, 2003
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER,...
K023800 · JOW
Aircast, Inc.
Cardiovascular · 88d
Cleared Feb 10, 2003
POLARIS DS
K024064 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 63d
Cleared Feb 10, 2003
ALLON 2001 VERSION 5
K024128 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 56d
Cleared Feb 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
K024153 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Feb 10, 2003
THOR DDII 830CL3 LASER SYSTEM
K030226 · NHN
Thor Intl.
Physical Medicine · 19d
Cleared Feb 10, 2003
NOBEL PERFECT IMPLANT SYSTEM
K030257 · DZE
Nobel Biocare Uas, Inc.
Dental · 17d
Cleared Feb 07, 2003
TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
K022696 · ITI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 178d
Cleared Feb 07, 2003
W & H LISA STEAM STERILIZER
K022816 · FLE
A-Dec, Inc.
General Hospital · 165d
Cleared Feb 07, 2003
NELLCOR INDGO MANUAL RESUSCITATOR
K023494 · BTM
Nellcor Puritan Bennett, Inc.
Anesthesiology · 112d
Cleared Feb 07, 2003
BD INTEGRA SYRINGE
K023752 · FMF
Bd
General Hospital · 91d
Cleared Feb 07, 2003
SOHNIKS
K023783 · HRX
Sohniks Endoscopy, Inc.
Orthopedic · 87d
Cleared Feb 07, 2003
AUTOMED 3000 INFUSION PUMP
K023863 · FRN
Help Technologies
General Hospital · 79d
Cleared Feb 07, 2003
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
K023868 · HAE
Dannoritzer Medical Instruments
Neurology · 79d
Cleared Feb 07, 2003
PREPARE CARTRIDGE
K023890 · MRZ
Appro Healthcare, Inc.
General Hospital · 78d
Cleared Feb 07, 2003
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
K024194 · NBW
Lifescan, Inc.
Chemistry · 49d
Cleared Feb 07, 2003
DIAMONDCOAT ULTRASONIC INSERTS
K030111 · ELC
Dentsply International
Dental · 25d
Cleared Feb 07, 2003
NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN...
K030126 · FLL
Norm Pacific Automation Corp.
General Hospital · 24d
Cleared Feb 07, 2003
SILICONE DUAL LUMEN RADPICC CATHETERS
K030255 · LJS
C.R. Bard, Inc.
General Hospital · 14d
Cleared Feb 06, 2003
FASSIRE-DUVAL TELESCOPIC IM SYSTEM
K020885 · HSB
Pega Medical, Inc.
Orthopedic · 325d
Cleared Feb 06, 2003
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
K021270 · GZJ
Biomedical Life Systems
Neurology · 290d
Cleared Feb 06, 2003
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
K021271 · GZJ
Biomedical Life Systems
Neurology · 290d
Cleared Feb 06, 2003
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K023593 · JZO
Quest Intl., Inc.
Immunology · 104d