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
73945–73968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2002
GAYHEART CORNEAL EXCISION DEVICE
K022843 · HRH
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
WIENER LAB. BILIRRUBINA TOTAL AA
K022962 · CIG
Wiener Laboratories Saic
Chemistry · 56d
Cleared Nov 01, 2002
LUCIUS 76
K023196 · EJT
Sb Lucius, Inc.
Dental · 37d
Cleared Nov 01, 2002
CERANUM 90
K023198 · EJT
Sb Lucius, Inc.
Dental · 37d
Cleared Nov 01, 2002
CONTROL PLASMA N
K023309 · GIZ
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
CONTROL PLASMA P
K023312 · GGC
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
ULTRASOUND SCANNER, TYPE 1101
K023457 · IYO
B & K Medical A/S
Radiology · 17d
Cleared Nov 01, 2002
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
K023538 · FLL
Medport, Inc.
General Hospital · 11d
Cleared Oct 31, 2002
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
K020689 · NJO
Midi, Inc.
Microbiology · 241d
Cleared Oct 31, 2002
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
K020749 · GZJ
Everyway Medical Instruments Co.,Ltd
Neurology · 238d
Cleared Oct 31, 2002
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
K020750 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 238d
Cleared Oct 31, 2002
PERMACOL
K021056 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 213d
Cleared Oct 31, 2002
MEDCOMP REPAIR KIT, MODEL ASPCRPK
K022570 · NFK
Medcomp
Gastroenterology & Urology · 90d
Cleared Oct 31, 2002
FLASH 1
K022583 · GEX
Emed, Inc.
General & Plastic Surgery · 87d
Cleared Oct 31, 2002
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
K022638 · GWM
Neurorecovery, Inc.
Neurology · 84d
Cleared Oct 31, 2002
KERADEC
K022663 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 83d
Cleared Oct 31, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML
K023273 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Oct 31, 2002
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
K023307 · JJX
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Oct 31, 2002
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
K023447 · DYB
St Jude Medical
Cardiovascular · 16d
Cleared Oct 31, 2002
OSSTAPLE, MAXILLOFACIAL
K023486 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 31, 2002
OSSTAPLE, CRANIOFACIAL
K023488 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 31, 2002
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
K023495 · DXN
Welch Allyn, Inc.
Cardiovascular · 13d
Cleared Oct 30, 2002
TRI-PLEX ADAPTER
K010401 · MOD
The Medical Device Group, Inc.
Anesthesiology · 625d
Cleared Oct 30, 2002
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE...
K022060 · GEX
Lumenis, Inc.
General & Plastic Surgery · 127d