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
164569–164592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1981
CARDIOPULMONARY BYPASS OXYGENATOR
K810505 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 58d
Cleared Apr 23, 1981
DISPOSABLE 2-STAGE CANNULA
K810515 · DWF
Texas Medical Products, Inc.
Cardiovascular · 57d
Cleared Apr 23, 1981
CHEM-DIALYTE CONCENTRATES
K810527 · KPO
Luchem Pharmaceuticals, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 23, 1981
DIRECT WRITING VECTORCARDIOGRAPH
K810529 · DYC
Elmed, Inc.
Cardiovascular · 56d
Cleared Apr 23, 1981
DISPOSABLE STOPCOCK
K810532 · DTZ
Texas Medical Products, Inc.
Cardiovascular · 56d
Cleared Apr 23, 1981
PACEMAKER LEAD ADAPTER
K810551 · DTD
Pacesetter Systems
Cardiovascular · 52d
Cleared Apr 23, 1981
TUBE FEEDING SET
K810573 · KNT
Harvard Laboratories
Gastroenterology & Urology · 51d
Cleared Apr 23, 1981
COBE DISPOSABLE PRESSURE TRANSDUCER
K810637 · DRS
Cobe Laboratories, Inc.
Cardiovascular · 44d
Cleared Apr 23, 1981
HO-B-LITE VI UNIT
K810668 · KGL
National Biological Corp.
General & Plastic Surgery · 42d
Cleared Apr 23, 1981
THE SUNFACTORY
K810688 · FTC
Wesgold Marketing, Inc.
Radiology · 41d
Cleared Apr 23, 1981
CURITY 100% SILICONE SAFETY INDICATOR
K810690 · KOD
The Kendal Co.
Gastroenterology & Urology · 41d
Cleared Apr 23, 1981
X-RAY IMAGE INTENSIFIER PRODUCTS
K810716 · JAA
Instrumentation Camera, Inc.
Radiology · 37d
Cleared Apr 23, 1981
PROCESS CHANGE
K810721 · FPA
Medlon, Inc.
General Hospital · 37d
Cleared Apr 23, 1981
EXETER OPERATING LOUPE
K810817 · HOH
Exeter Instruments, Inc.
Ophthalmic · 30d
Cleared Apr 23, 1981
DECALCIFIER II
K810836 · KDX
Surgipath
Pathology · 28d
Cleared Apr 23, 1981
CYTOBUCKET MODEL 1024
K810848 · IFB
Cytochem, Inc.
Pathology · 27d
Cleared Apr 23, 1981
SPECTRUM ANALYZER 8000
K810851 · DXG
Radionics Medical, Inc.
Cardiovascular · 24d
Cleared Apr 23, 1981
STAR
K810873 · JWM
Intl. General Electric Co.
Radiology · 23d
Cleared Apr 23, 1981
FETAL CALF SERUM
K810874 · KIS
Tissue Culture Biologicals
Microbiology · 23d
Cleared Apr 23, 1981
OMED SILICONE INSTRUMENT COVERS
K810883 · KDC
Omega-Med Intl., Inc.
General & Plastic Surgery · 22d
Cleared Apr 23, 1981
ADEL MEDICAL BIRTHING BED, #LD-500
K810886 · HDD
Adel Medical , Ltd.
Obstetrics & Gynecology · 22d
Cleared Apr 23, 1981
BOUNDARY TUBING HOLDERS
K810888 · FZX
The Buckeye Cellulose Corp.
General & Plastic Surgery · 21d
Cleared Apr 23, 1981
COLTENE ORALLY
K810907 · EJJ
Coltene, Inc.
Dental · 20d
Cleared Apr 23, 1981
ALLOY COMPOSITE POLISH
K810912 · EJR
Moyco Industries, Inc.
Dental · 17d