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
148897–148920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · FOS
Vygon Corp.
General Hospital · 70d
Cleared May 21, 1985
T-SWIPE -TONGUE CLEANER
K851006 · LCN
Kumar Ent.
Dental · 70d
Cleared May 21, 1985
MAYFIELD TABLE-ELECTRIC
K851021 · GDC
Ohio Medical Instrument Co., Inc.
General & Plastic Surgery · 70d
Cleared May 21, 1985
MOI-STIR ORAL SWABSTICK(S)
K851026 · LFD
Kingswood Laboratories, Inc.
Dental · 70d
Cleared May 21, 1985
CANON X-RAY FILM CHANGER CFC-U1
K851067 · KPX
Canon USA, Inc.
Radiology · 64d
Cleared May 21, 1985
VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH
K851086 · FTM
Ethicon, Inc.
General & Plastic Surgery · 64d
Cleared May 21, 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273 · DHB
Pharmacia, Inc.
Chemistry · 50d
Cleared May 21, 1985
MICROCOR ECG MONITOR
K851325 · DRT
Microcor, Inc.
Cardiovascular · 47d
Cleared May 21, 1985
HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION
K851367 · DZE
Orthomatrix, Inc.
Chemistry · 46d
Cleared May 21, 1985
TRANDUCER PROTECTOR
K851428 · FIB
Galvin Industries, Inc.
Gastroenterology & Urology · 41d
Cleared May 21, 1985
VISILUX 2 VISIBLE LIGHT CURING UNIT
K851459 · EBF
3M Company
Dental · 40d
Cleared May 21, 1985
SPECTRUM 150 DT
K851644 · IYX
Raytheon Medical Systems
Radiology · 32d
Cleared May 21, 1985
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
K851665 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared May 21, 1985
LARYNGOSCOPE
K851705 · CCW
Armstrong Ind., Inc.
Anesthesiology · 26d
Cleared May 21, 1985
GENERAL HOSPITAL INSTRUMENTS
K851852
Biological & Environmental Control...
General & Plastic Surgery · 25d
Cleared May 21, 1985
BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA
K851880 · GFA
J-Pac, LLC
General & Plastic Surgery · 22d
Cleared May 21, 1985
DOUBLE ACTION PIN CUTTER
K851896
Med-Tool, Inc.
General & Plastic Surgery · 21d
Cleared May 21, 1985
SURGICAL EYE PACK
K851906 · HMP
Xanmed Corp.
General & Plastic Surgery · 20d
Cleared May 20, 1985
ELVI 655 FLAME PHOTOMETER
K843375 · JJO
Logos Scientific, Inc.
Chemistry · 265d
Cleared May 20, 1985
ABBOTT HSV EIA
K843622 · LGC
Abbott Laboratories
Immunology · 248d
Cleared May 20, 1985
VIROGEN RUBELLA SLIDE TEST
K844435 · LQN
Armkel, LLC
Microbiology · 185d
Cleared May 20, 1985
NEUROLAB II
K844481 · GWS
Teca, Inc.
Neurology · 182d
Cleared May 20, 1985
MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
K845021 · HIF
Medline Industries, Inc.
Obstetrics & Gynecology · 144d
Cleared May 20, 1985
ORTHOPEDIC IMPLANT SCREWS
K850024 · HWC
Kirkstil Corp., Inc.
Orthopedic · 137d