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
158185–158208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1982
POLYCORE
K822542
Polycore Optical Pte , Ltd.
Ophthalmic · 126d
Cleared Dec 27, 1982
MULTI IMAGE CAMERA
K828620
Lenzar Medical Corp.
Radiology · 80d
Cleared Dec 26, 1982
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
K823402 · CDQ
Emd Chemicals, Inc.
Chemistry · 41d
Cleared Dec 22, 1982
TITAN GEL LDH ISOENZYME KIT
K821983 · CEX
Helena Laboratories
Chemistry · 169d
Cleared Dec 22, 1982
EXTRACORPOREAL BLOOD GAS SYSTEM
K822000 · DTY
Cardiovascular Devices, Inc.
Cardiovascular · 168d
Cleared Dec 22, 1982
DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
K823271 · BZO
Intec Medical, Inc.
Anesthesiology · 50d
Cleared Dec 22, 1982
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 49d
Cleared Dec 22, 1982
RIASET PROLACTIN RIA KIT
K823304 · CFT
Immulok, Inc.
Chemistry · 47d
Cleared Dec 22, 1982
IN VITRO GAMMACOAT B-HCG RADIO. TEST
K823313 · JHI
Clinical Assays, Inc.
Chemistry · 47d
Cleared Dec 22, 1982
TRIGLYCERIDES REAGENT SET TAG-GK
K823341 · CDT
Sterling Biochemical, Inc.
Chemistry · 44d
Cleared Dec 22, 1982
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
K823354 · CHH
Emd Chemicals, Inc.
Chemistry · 47d
Cleared Dec 22, 1982
DURAPULSE
K823371 · DXY
Cpm International, Inc.
Cardiovascular · 40d
Cleared Dec 22, 1982
125-I FSH RADIOIMMUNOASSAY KIT
K823379 · CGJ
Clinetics Corp.
Chemistry · 40d
Cleared Dec 22, 1982
125-I LH RADIOIMMUNOASSAY KIT
K823380 · CEP
Clinetics Corp.
Chemistry · 40d
Cleared Dec 22, 1982
SOPHEIA GENTAMICIN EIA KIT
K823387 · LCD
Diagnostic Products Corp.
Chemistry · 37d
Cleared Dec 22, 1982
VOLUMERIC CONTROLLER
K823404 · LDR
Quest Medical, Inc.
General Hospital · 37d
Cleared Dec 22, 1982
GUARDIAN 110, VOL. CONTROL DELIV. SYS
K823406 · FRN
Avi, Inc.
General Hospital · 37d
Cleared Dec 22, 1982
PHILLY BOLT ADULT PROCEDURE KIT
K823459 · GWN
Philadelphia Medical Specialties
Neurology · 34d
Cleared Dec 22, 1982
BE #16 - MANIFOLD
K823481 · BZO
Instrumentation Industries, Inc.
Anesthesiology · 29d
Cleared Dec 22, 1982
THERMAL DILUTION CATHETER
K823484 · DYG
Instrumentation Laboratory CO
Cardiovascular · 29d
Cleared Dec 22, 1982
GLISLENS
K823528 · HPX
Bio-Products, Inc.
Ophthalmic · 22d
Cleared Dec 22, 1982
H 12 07
K823589 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 16d
Cleared Dec 22, 1982
PLASTIC BUILT-UP HANDLE EATING UTENSILS
K823594 · ILC
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
HEAD SUPPORT FOR WHEELCHAIR
K823595 · KNO
Fred Sammons, Inc.
Physical Medicine · 16d