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
93769–93792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1997
OPTIMA PLUS E DENTAL CHAIR
K971063 · KLC
King Dental Corp.
Dental · 71d
Cleared Jun 03, 1997
BIOACCESS MARROW HARVEST SYSTEM
K971114 · GDM
Bioaccess, Inc.
General & Plastic Surgery · 69d
Cleared Jun 03, 1997
AUTO SUTURE* ILM** KIT
K971201 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 63d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS CAL 5 PLUS
K971283 · JIX
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 03, 1997
OPALDAM
K971284 · EIG
Ultradent Products, Inc.
Dental · 57d
Cleared Jun 03, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS...
K971411 · EMX
Bentec Medical, Inc.
Ear, Nose, Throat · 48d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
K971506 · DMT
Beckman Instruments, Inc.
Toxicology · 39d
Cleared Jun 03, 1997
COMPOGLASS F
K971513 · EBF
Ivoclar North America, Inc.
Dental · 36d
Cleared Jun 03, 1997
NOVATIP FAMILY OF LASER HANDPIECE TIPS
K971539 · GEX
Xanova Corp.
General & Plastic Surgery · 36d
Cleared Jun 03, 1997
STERILE FLEXOFILE FILES AND INSTRUMENTS
K971606 · EFA
Dentsply Intl.
Dental · 33d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF...
K971788 · DHR
Beckman Instruments, Inc.
Immunology · 20d
Cleared Jun 03, 1997
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET
K971911 · FEN
Medamicus, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 02, 1997
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · FMI
Vygon Corp.
General Hospital · 270d
Cleared Jun 02, 1997
OPTICAL TRACKING SYSTEM (OTS)
K964801 · HAW
Radionics Software Applications, Inc.
Neurology · 185d
Cleared Jun 02, 1997
PERIPHERALLY INSERTED CENTRAL CATHETER
K964929 · LJS
B.Braun Medical, Inc.
General Hospital · 175d
Cleared Jun 02, 1997
QUANTA LITE IGA GLIADIN ELISA
K964986 · MST
Inova Diagnostics, Inc.
Immunology · 171d
Cleared Jun 02, 1997
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
K970446 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 117d
Cleared Jun 02, 1997
CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
K970767 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 02, 1997
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE
K970792 · HIS
Titan Condoms
Obstetrics & Gynecology · 90d
Cleared Jun 02, 1997
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
K970942 · GWQ
Physiometrix, Inc.
Neurology · 80d
Cleared Jun 02, 1997
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER
K971085 · LJS
B.Braun Medical, Inc.
General Hospital · 69d
Cleared Jun 02, 1997
SILICONE PUTTY EAR PLUGS
K971517 · EWD
Bentec Medical, Inc.
Ear, Nose, Throat · 38d
Cleared Jun 02, 1997
ELECSYS FERRITIN
K971833 · JMG
Boehringer Mannheim Corp.
Immunology · 14d
Cleared May 30, 1997
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
K951927 · BSO
Csen , Ltd.
Anesthesiology · 767d