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

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176,076 results
151993–152016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1984
CUSTOM NEURO TRAY
K842625
Deroyal Industries, Inc.
Neurology · 76d
Cleared Sep 20, 1984
GENERAL SURGERY TRAY
K842648 · LRO
Deroyal Industries, Inc.
General & Plastic Surgery · 38d
Cleared Sep 20, 1984
NU-THOR THORACOSTOMY KIT
K842666 · KGZ
Intl. Medical Devices , Ltd.
General & Plastic Surgery · 72d
Cleared Sep 20, 1984
SANG-A PETROLATUM GAUZE USP STERILE
K843035 · FRO
Tech-Cons Ltd., Intl.
General & Plastic Surgery · 49d
Cleared Sep 20, 1984
SENTRA
K843060 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 20, 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185 · FPA
Y
General Hospital · 38d
Cleared Sep 20, 1984
WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP
K843188 · JOL
Wells Johnson Co.
General Hospital · 38d
Cleared Sep 20, 1984
ECLIPSE HEART SUPPORT FOR CORONARY ARTER
K843216 · GAD
Biotrac Laboratories
General & Plastic Surgery · 36d
Cleared Sep 20, 1984
ARROW-JOHANS ECG ADAPTOR
K843263 · DQY
Arrow Intl., Inc.
Cardiovascular · 31d
Cleared Sep 20, 1984
SYSTEMATE T-BILI 67212
K843328 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE D-BILI 67213
K843329 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GOT 67208
K843333 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GPT 67209
K843334 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
RAICHEM CALCIUM REAGENT
K843353 · CIC
Reagents Applications, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
ACID PHOSPHATASE ASSAY KIT
K843380 · CKE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Sep 20, 1984
EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT
K843458 · DKZ
Syva Co.
Toxicology · 15d
Cleared Sep 19, 1984
TRACHEAL TUBE 16 GAUGE-1.65MM-
K832466 · BTO
Erie Medical
Anesthesiology · 421d
Cleared Sep 19, 1984
ACKRAD HYSTEROSALPINGOGRAPHY SET
K842231 · KNA
Ackrad Laboratories
Obstetrics & Gynecology · 106d
Cleared Sep 19, 1984
OB ULTRASOUND LINEAR SCANNER 630
K842261 · HEM
Ge Medical Systems Information...
Obstetrics & Gynecology · 104d
Cleared Sep 19, 1984
AUTOMATIC PATIENT CHAIR PM2000 & A
K842359
Planmeca USA, Inc.
Dental · 89d
Cleared Sep 19, 1984
MEDCOLATOR MODEL GX
K842712 · IPF
Medco Products, Co., Inc.
Physical Medicine · 69d
Cleared Sep 19, 1984
DISPOSABLE TISSUE EFFECT BIOSENSOR-T
K843157 · FLL
Pan Dynamics Medical Corp.
General Hospital · 40d
Cleared Sep 19, 1984
SONIC AID GREEN ULTRASOUND GEL
K843167 · IYO
Wpc Brands, Inc.
Radiology · 37d
Cleared Sep 19, 1984
LOW PRESSURE ALARM FOR OXYGEN CYLINDER
K843212 · BXH
Hospitak, Inc.
Anesthesiology · 35d