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
164281–164304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1981
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367 · DLZ
Kallestad Laboratories, Inc.
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC PROGESTERONE
K811369 · JLS
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC HPL
K811370 · JMF
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC ESTRIOL
K811371 · CGI
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
AMES SERA-PAK GLUCOSE REAGENT
K811392 · CGA
Miles Laboratories, Inc.
Chemistry · 11d
Cleared May 29, 1981
EARLY PREGNANCY DETECTION
K811398 · JHI
Immuchem Corp.
Chemistry · 11d
Cleared May 28, 1981
STANDARD METHODS AGAR
K811321 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
POTATO DEXTROSE AGAR
K811322 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
NUTRIENT BROTH
K811323 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
PHENYLETHANOL AGAR
K811324 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SABOURAUD DEXTROSE AGAR
K811325 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SABOURAUD LIQUID, BROTH MODIFIED
K811326 · JSD
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SALMONELLA SHIGELLA AGAR
K811327 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
SCHAEDLER AGAR
K811328 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 16d
Cleared May 28, 1981
HUMERAL FRACTURE CAST BRACE
K811343 · IQI
Deseret Medical, Inc.
Physical Medicine · 16d
Cleared May 27, 1981
SIRECUST 358
K803208 · DSI
Siemens Corp.
Cardiovascular · 160d
Cleared May 27, 1981
NITROGLYCERINE IV SET
K810317 · FPA
Abbott Laboratories
General Hospital · 110d
Cleared May 27, 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677 · DXY
Medtronic, Inc.
Cardiovascular · 75d
Cleared May 27, 1981
GASTRIN RADIOIMMUNOASSAY TEST
K810722 · CGC
Clinical Assays, Inc.
Chemistry · 71d
Cleared May 27, 1981
DENTMED V-PACKS
K810801 · EFQ
Univ. of Bristol Dental School
General & Plastic Surgery · 65d
Cleared May 27, 1981
AR-1 PHYSIOLOGICAL PRODESSOR
K810880 · HCC
Atlas Researches , Ltd.
Neurology · 57d
Cleared May 27, 1981
EMG 3510/EMG 3510D MYOFEEDBACK MONITORS
K810881 · HCC
Atlas Researches , Ltd.
Neurology · 57d
Cleared May 27, 1981
ASR-3520 SKIN RESPONSE MONITOR
K810882 · HCC
Atlas Researches , Ltd.
Neurology · 57d
Cleared May 27, 1981
HUCKSTEP INTRAMEDULLARY NAIL
K811017 · KTT
Downs Surgical , Ltd.
Orthopedic · 42d