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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
153313–153336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1984
HOSPAL MODEL H1210
K840814 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 45d
Cleared Apr 02, 1984
MEDICAL LASER ENDOCOAGULATOR 5K
K840854 · HQF
Hgm, Inc.
Ophthalmic · 38d
Cleared Apr 01, 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · DRX
Graphic Controls Corp.
Cardiovascular · 107d
Cleared Apr 01, 1984
IMMPULSE TBC ASSAY REAGENTS
K840853 · KHQ
Paragon Diagnostics, Inc.
Chemistry · 37d
Cleared Mar 30, 1984
INTRAVENOUS NEEDLE
K832904 · FMI
Yolan R. Guttman
General Hospital · 214d
Cleared Mar 30, 1984
BSD-200
K833158 · FLL
Bsd Medical Corp.
General Hospital · 196d
Cleared Mar 30, 1984
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
K833304 · DZM
Smith & Nephew, Mpl Division
Dental · 189d
Cleared Mar 30, 1984
PRE-LOADED C-R TUBES FOR SYRINGE
K833725 · EBF
Centrix, Inc.
Dental · 158d
Cleared Mar 30, 1984
CANAL HEARING AID
K833773 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 155d
Cleared Mar 30, 1984
VASCULAR ACCESS CATH. REPAIR KIT
K833915 · LJS
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 137d
Cleared Mar 30, 1984
WESCOR 5500 VAPOR PRESSURE OSMOMETER
K834214 · JJM
Wescor, Inc.
Chemistry · 116d
Cleared Mar 30, 1984
NIGHT TRAINER
K834311 · KPN
Maddak, Inc.
Gastroenterology & Urology · 126d
Cleared Mar 30, 1984
KEATES IRRIGATION/ASPIRATION/VITREOUS
K834437 · HQE
Frigitronics of Connecticut, Inc.
Ophthalmic · 102d
Cleared Mar 30, 1984
POCKETIP 4414
K834545 · EFS
Vipont Laboratories, Inc.
Dental · 94d
Cleared Mar 30, 1984
MENSTRUAL PADS
K834564 · HHL
Probel-U.S., Inc.
Obstetrics & Gynecology · 93d
Cleared Mar 30, 1984
VENTILATORY FREQUENCY MONITOR
K834569 · BZO
Cryo Corp.
Anesthesiology · 92d
Cleared Mar 30, 1984
CHEMODENT CERAMIC METAL
K840014 · EJS
Chemodent Metal Co.
Dental · 86d
Cleared Mar 30, 1984
COLTENE BRILLIANT LUX
K840084 · EBF
Bauer, Cheng & Associates, Inc.
Dental · 80d
Cleared Mar 30, 1984
THYROXINE EMIA
K840241 · KLI
Collaborative Research, Inc.
Chemistry · 70d
Cleared Mar 30, 1984
MCS TOTAL PROTEIN REAGENT
K840290 · CEK
Medilab Corp.
Chemistry · 66d
Cleared Mar 30, 1984
MCS ALBUMIN REAGENT
K840291 · CIX
Medilab Corp.
Chemistry · 66d
Cleared Mar 30, 1984
RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
K840301 · CGI
New England Nuclear
Chemistry · 66d
Cleared Mar 30, 1984
DURAZYME CHOLESTEROL
K840368 · CHH
American Monitor Corp.
Chemistry · 63d
Cleared Mar 30, 1984
CORNINGS MAGIC FERRITIN RADIOIMMUNO-
K840460 · JMG
Corning Medical & Scientific
Chemistry · 57d