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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143137–143160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1986
MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE
K862251 · KNX
Bio-Flow, Inc.
Gastroenterology & Urology · 84d
Cleared Sep 04, 1986
MODEL RCV REFLUX CHECK VALVE
K862327 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 77d
Cleared Sep 04, 1986
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374 · GKL
Instrumentation Laboratory CO
Hematology · 72d
Cleared Sep 04, 1986
ACS WIRE SHAPER
K862567 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Sep 04, 1986
INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
K862591 · DTM
Medical, Inc.
Cardiovascular · 59d
Cleared Sep 04, 1986
INTERFACE ARTERIAL BLOOD FILTER, MODEL 44
K862609 · DTM
Medical, Inc.
Cardiovascular · 58d
Cleared Sep 04, 1986
CYTOTECH CIC ENZYME IMMUNOASSAY
K862649 · DAK
Cytotech, Inc.
Immunology · 55d
Cleared Sep 04, 1986
NOVACYTE-U
K862665 · KDT
Xsirius Medical, Inc.
Pathology · 52d
Cleared Sep 04, 1986
TINA-QUANT(R) IGA
K862763 · CZP
Boehringer Mannheim Corp.
Immunology · 44d
Cleared Sep 04, 1986
ASSERACHROM PF4 KIT
K862774 · LCO
American Bioproducts Co.
Hematology · 44d
Cleared Sep 04, 1986
HI-LO ELEVATOR FLAT TABLE
K862825 · IXQ
Garrels X-Ray Products, Inc.
Radiology · 41d
Cleared Sep 04, 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · DXY
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-890
K863084 · GKL
Coulter Electronics, Inc.
Hematology · 23d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-540
K863085 · GKL
Coulter Electronics, Inc.
Hematology · 23d
Cleared Sep 04, 1986
TOTAL HEMOGLOBIN
K863104 · KHG
J. D. Assoc.
Hematology · 21d
Cleared Sep 04, 1986
IL CELLECT 7
K863290 · GKL
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 04, 1986
IL CELLECT 8
K863291 · GKL
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 03, 1986
MICRO PORT
K862018 · LJT
Intermedics/Infusaid, Inc.
General Hospital · 104d
Cleared Sep 03, 1986
IL SYSTEM 810, ACL AND THE REAGENT SETS
K862301 · GJA
Instrumentation Laboratory CO
Hematology · 78d
Cleared Sep 03, 1986
SENSORY 6
K862338 · HPG
Brytech, Inc.
Ophthalmic · 75d
Cleared Sep 03, 1986
HOYER DIGITAL ELECTRONIC SCALE
K862477 · FRW
Ted Hoyer & Co., Inc.
General Hospital · 65d
Cleared Sep 03, 1986
MECHANICAL INFLATION DEVICE
K862547 · DXT
American Edwards Laboratories
Cardiovascular · 62d
Cleared Sep 03, 1986
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K862630 · GSA
Medical Diagnostic Technologies, Inc.
Microbiology · 55d
Cleared Sep 03, 1986
ENZYMATIC BLOOD GLUCOSE
K862721 · CGA
U. S. Diagnostics, Inc.
Chemistry · 48d