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
155593–155616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1983
BRONCHO FIBERSCOPE FB-19C
K832492 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 55d
Cleared Sep 20, 1983
SODIUM TEST KIT
K832552 · CEI
Mallinckrodt Critical Care
Chemistry · 50d
Cleared Sep 20, 1983
POTASSIUM TEST KIT
K832553 · CEJ
Mallinckrodt Critical Care
Chemistry · 50d
Cleared Sep 20, 1983
PRE-BYPASS FILTER #EC-PBF SERIES
K832594 · KRJ
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Sep 20, 1983
EARLY IN HOME PREGNANCY TEST
K832599 · JHJ
Warner-Lambert Co.
Chemistry · 49d
Cleared Sep 20, 1983
INTUBATION KIT
K832629 · BTR
Calbio, Inc.
Anesthesiology · 47d
Cleared Sep 20, 1983
BIOSPAL 3000 S
K832645 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 46d
Cleared Sep 20, 1983
ACCLAIM
K832648 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 46d
Cleared Sep 20, 1983
BIOSPAL 1200S
K832659 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 43d
Cleared Sep 20, 1983
WHEELCHAIR-VARIOUS MODELS
K832685 · IOR
Health America
Physical Medicine · 49d
Cleared Sep 20, 1983
RISER STANDUP WHEELCHAIR
K832696 · IPL
Imex Medical Systems, Inc.
Physical Medicine · 41d
Cleared Sep 20, 1983
DUAL DIAL VENTURI STYLE MASK
K832725 · BYF
Airlife, Inc.
Anesthesiology · 39d
Cleared Sep 20, 1983
MOBIE
K832727 · INI
Everest & Jennings, Inc.
Physical Medicine · 39d
Cleared Sep 20, 1983
FEMORAL FRACTURE ORTHOSIS
K832740
Orthomedics
Orthopedic · 36d
Cleared Sep 20, 1983
JASON CERVICAL ORTHOSIS
K832741 · IQF
Orthomedics
Physical Medicine · 36d
Cleared Sep 20, 1983
EXTENSION CONTROL KNEE ORTHOSIS
K832742 · ITM
Orthomedics
Physical Medicine · 36d
Cleared Sep 20, 1983
OC3 FLYER
K832745 · ITI
Intl. Medical Equipment Corp.
Physical Medicine · 36d
Cleared Sep 20, 1983
S & W SW52E W/POWER BACK LIFT
K832768 · LGX
S & W Enterprises, Inc.
General Hospital · 35d
Cleared Sep 20, 1983
STEAM PAK MOIST HEAT
K832803 · IMA
Electro-Med Health Industries, Inc.
Physical Medicine · 33d
Cleared Sep 20, 1983
SESAM TABLE
K832804 · INQ
Electro-Med Health Industries, Inc.
Physical Medicine · 33d
Cleared Sep 20, 1983
SHILEY 3L CARDF PLUS
K832811 · DTP
Shiley, Inc.
Cardiovascular · 33d
Cleared Sep 19, 1983
CATHETER CARE TRAY
K832389 · KOD
Inmed Corp.
Gastroenterology & Urology · 62d
Cleared Sep 19, 1983
UROTRACK PLUS
K832526 · KNX
Vital Metrics, Inc.
Gastroenterology & Urology · 52d
Cleared Sep 16, 1983
AMBULATORY MARK XI DRUG INFUSION DEV-
K830657 · FRN
Windsor Medical, Inc.
General Hospital · 198d