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
154777–154800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1983
CLIRANS MODEL TAF 15 HOLLOW FIBER
K833503 · KOC
Terumo Medical Corp.
Gastroenterology & Urology · 64d
Cleared Dec 08, 1983
TOXI CHEM SERUM ALCOHOL CONTROL
K833514 · DKC
Fisher Diagnostics
Toxicology · 58d
Cleared Dec 08, 1983
CT SCANNING ACCESSORIES
K833531 · JAA
Lds Hospital
Radiology · 64d
Cleared Dec 08, 1983
MODIFICATION OF EMIT AND AMIKACIN ASSAY
K833546 · LDN
Syva Co.
Toxicology · 55d
Cleared Dec 08, 1983
RTP-5100-5200-5300 & 5400
K833560 · JAD
Adac Laboratories
Radiology · 51d
Cleared Dec 08, 1983
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY
K833623 · KLR
Syva Co.
Toxicology · 55d
Cleared Dec 08, 1983
BRONCHITRAC DF DUAL RESP/CATHETER
K833633 · BSY
Ackrad Laboratories
Anesthesiology · 52d
Cleared Dec 08, 1983
RESCUE VALVE
K833748 · CBP
Respironics, Inc.
Anesthesiology · 43d
Cleared Dec 08, 1983
BEHIND-THE-EAR HEARING AIDS T-87 &
K833775 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 42d
Cleared Dec 08, 1983
OTICON, E26P
K833803 · ESD
Oticon Corp.
Ear, Nose, Throat · 37d
Cleared Dec 08, 1983
DUAL LUMEN SUBCLAVIAN CANNULA
K833848 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 34d
Cleared Dec 08, 1983
COAGULASE PLASMA, HORSE & RABBIT EDTA
K833858 · JTL
Otisville Biotech, Inc.
Microbiology · 31d
Cleared Dec 08, 1983
MUELLER HINTON AGAR
K833861 · JTZ
American Biomedical Corp.
Microbiology · 31d
Cleared Dec 08, 1983
BACTROL GRAM SLIDE
K833901 · JTO
Difco Laboratories, Inc.
Pathology · 24d
Cleared Dec 08, 1983
BRETHANCER, DRUG DELIVERY SYS-INHAL
K833922 · CAF
Ciba-Geigy Corp.
Anesthesiology · 24d
Cleared Dec 08, 1983
CATALOG 6400 OXYGEN CONCENTRATOR
K833938 · CAW
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 23d
Cleared Dec 06, 1983
DIF-STET
K832882 · DQD
Intersect Systems, Inc.
Cardiovascular · 102d
Cleared Dec 06, 1983
MINI-PECG
K832883 · DPS
Intersect Systems, Inc.
Cardiovascular · 102d
Cleared Dec 05, 1983
WISDOM AIRWAY
K833482 · CAE
Wisdom Corp.
Anesthesiology · 59d
Cleared Dec 03, 1983
DERMATOLOGY HANDPIECE-OPHTH LASER
K833274 · HQF
Synemed, Inc.
Ophthalmic · 73d
Cleared Dec 02, 1983
MACLEAN-FOGG, TISSUE CASSETTES
K833857 · IDZ
Polymer Technology Corp.
Pathology · 25d
Cleared Dec 01, 1983
PATIENT MONITOR CM 135
K831164 · DRT
Honeywell, Inc.
Cardiovascular · 234d
Cleared Dec 01, 1983
BIOSENSOR ASC SYSTEM
K831676 · DSI
Biosensor Corp.
Cardiovascular · 192d
Cleared Dec 01, 1983
G-2000
K832227 · DPS
Eaton Medical Group
Cardiovascular · 146d