Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
159025–159048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1982
CBM, CORE BUILD-UP MATERIAL
K823732 · EBD
Scientific Pharmaceuticals, Inc.
Dental · 18d
Cleared Dec 28, 1982
PORCELAIN ARTIFICIAL TEETH
K823744 · ELL
Dentsply Intl.
Dental · 15d
Cleared Dec 27, 1982
SINGLE VISION POWER LENS
K822429
Polycore Optical Pte , Ltd.
Ophthalmic · 137d
Cleared Dec 27, 1982
KRYPTOX-ROUND SEGMENT BIFOCAL
K822430
Polycore Optical Pte , Ltd.
Ophthalmic · 137d
Cleared Dec 27, 1982
SUNGLASS & SAFETY PLANO LENS
K822431
Polycore Optical Pte , Ltd.
Ophthalmic · 137d
Cleared Dec 27, 1982
VISIOPAL 75
K822541
Polycore Optical Pte , Ltd.
Ophthalmic · 126d
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