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
142489–142512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1986
AEROSOL-T
K863318 · BZA
Southmedic, Inc.
Anesthesiology · 16d
Cleared Sep 11, 1986
CODE-A-WELL SERIES 1-600, 1-625
K863374 · JTC
Plastic Injectors, Inc.
Microbiology · 8d
Cleared Sep 09, 1986
MAXI-USE O2 DEVICE
K861325 · NFB
B & F Medical Products, Inc.
Anesthesiology · 153d
Cleared Sep 09, 1986
AGAR 9K TENS
K861894 · GZJ
Solcoor, Inc.
Neurology · 116d
Cleared Sep 09, 1986
UNI-TENS
K861895 · GZJ
Solcoor, Inc.
Neurology · 116d
Cleared Sep 09, 1986
UNI-TENS XL TENS
K861896 · GZJ
Solcoor, Inc.
Neurology · 116d
Cleared Sep 09, 1986
DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM
K862304 · FKQ
Cd Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Sep 09, 1986
HCI Y-CONNECTOR
K862484 · KOD
Hospital Concepts, Inc.
Gastroenterology & Urology · 71d
Cleared Sep 09, 1986
SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
K862539 · FAD
Mentor Corp.
Gastroenterology & Urology · 69d
Cleared Sep 09, 1986
AMYLASE LTS
K862640 · CJA
Electro-Nucleonics Laboratories, Inc.
Chemistry · 61d
Cleared Sep 09, 1986
HEMOFILTRATION SYSTEM 10
K862716 · FII
Gambro, Inc.
Gastroenterology & Urology · 54d
Cleared Sep 09, 1986
VERSA STIM
K862718 · GXY
Conmedcorp
Neurology · 54d
Cleared Sep 09, 1986
RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
K862909 · BTO
Intl. Medical Devices , Ltd.
Anesthesiology · 40d
Cleared Sep 09, 1986
ALP S.C.E.
K863051 · CJE
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
ALPHA AMYLASE
K863052 · CJA
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
BILIFAST
K863055 · CIG
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CLOROFAST
K863061 · CHJ
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CHOLESTEROL-E FAST (TOTAL)
K863063 · CHH
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
PHOSPHOLIPIDS-E
K863071 · CEQ
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
FOSFOROMETER
K863072 · CEO
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
TOTAL LIPIDS
K863073 · CFD
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
TOTAL PROTEINS
K863074 · CEK
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
UREAFAST
K863076 · CDL
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CREATININE-E
K863078 · JFY
J. D. Assoc.
Chemistry · 28d