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
172609–172632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1978
RABBIT ANTIBODY/THYROID STIMUL. HORMONE
K780059 · JLW
Pcl-Ria, Inc.
Chemistry · 34d
Cleared Feb 13, 1978
CPK REAGENT SET
K780070 · CGS
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
HBDH REAGENT SET
K780073 · JMK
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
LDH-L REAGENT SET
K780074
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
CANNULA, ARTERY, RENAL
K780079 · DQR
Dravon Medical, Inc.
Cardiovascular · 28d
Cleared Feb 13, 1978
GLUCOSE REAGENT FOR GLUCOSE ANALYZER
K780093 · CGA
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
IRON BINDING CAPACITY CHEMISTRY
K780094 · JMO
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
ULTRAZYME PLUS ALP
K780095 · CJE
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
ULTRAZYME PLUS GPT
K780102 · CKA
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
ULTRAZYME PLUS GOT
K780103 · CIT
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
ULTRAZYME PLUS HBD
K780104 · JMK
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
CARDIAC PULSE GENERATOR, MODEL 160B
K780113 · DXY
Telectronics, Inc.
Cardiovascular · 25d
Cleared Feb 13, 1978
NEONATAL SCREENING AUDIOMETER
K780150 · EWO
Telediagnostic Systems, Inc.
Ear, Nose, Throat · 14d
Cleared Feb 13, 1978
RADIATION TREATMENT PLANNING SYSTEM
K780157 · JAD
Capintec, Inc.
Radiology · 14d
Cleared Feb 13, 1978
ANASWAB
K780159 · JTX
Scott Laboratories, Inc.
Microbiology · 14d
Cleared Feb 13, 1978
MASK, SURGICAL
K780169 · FXX
Convertors
General Hospital · 11d
Cleared Feb 13, 1978
TEST SYS. FOR NDNA ANTIBODY DETERM.
K780178 · DHN
Zeus Scientific, Inc.
Immunology · 10d
Cleared Feb 13, 1978
TOBRAMYCIN 125I RIA KIT
K780182 · DID
New England Nuclear
Microbiology · 10d
Cleared Feb 13, 1978
WHEELCHAIRS, MECHANICAL
K780183 · IOR
Orthopedic Equipment Co., Inc.
Physical Medicine · 10d
Cleared Feb 13, 1978
WHEELCHAIR ACCESSORIES
K780184 · IMX
Orthopedic Equipment Co., Inc.
Physical Medicine · 10d
Cleared Feb 07, 1978
THYROID STIMULATING HORMONE
K780015 · JLW
Pcl-Ria, Inc.
Immunology · 35d
Cleared Feb 07, 1978
THYRO-INDICATOR T-3 125I
K780018 · CDP
Clinical Immuno-Diagnostics
Immunology · 35d
Cleared Feb 07, 1978
ALP REAGENT SET
K780068 · CJE
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Feb 07, 1978
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080 · CFE
Corning Medical & Scientific
Chemistry · 22d