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
55993–56016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2008
NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
K082033 · GEX
Global USA Distribution, LLC
General & Plastic Surgery · 14d
Cleared Jul 30, 2008
LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR)
K071759 · GEI
Live Tissue Connect, Inc.
General & Plastic Surgery · 398d
Cleared Jul 30, 2008
FABIUS MRI
K072884 · BSZ
Draeger Medical AG & Co. KG
Anesthesiology · 295d
Cleared Jul 30, 2008
JOINT STIM, MODEL 1000
K073386 · NYN
Pain Management Technologies
Neurology · 240d
Cleared Jul 30, 2008
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J)...
K080668 · DTK
C.R. Bard, Inc.
Cardiovascular · 142d
Cleared Jul 30, 2008
GENADYNE A4 POWERED SUCTION PUMP
K080745 · BTA
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 135d
Cleared Jul 30, 2008
ANCHORAGE SCOPE, MODEL 000003
K080780 · FBO
Epitek, Inc.
Gastroenterology & Urology · 133d
Cleared Jul 30, 2008
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
K080832 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 127d
Cleared Jul 30, 2008
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
K080896 · OIW
Pathwork Diagnostics, Inc.
Pathology · 121d
Cleared Jul 30, 2008
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
K080995 · NSU
Affymetrix, Inc.
Chemistry · 114d
Cleared Jul 30, 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
K081113 · FOZ
Cook, Inc.
General Hospital · 103d
Cleared Jul 30, 2008
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
K081244 · KTT
Biomet Trauma
Orthopedic · 90d
Cleared Jul 30, 2008
THD SLIDE
K081429 · JAF
Thd Spa
Radiology · 70d
Cleared Jul 30, 2008
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K081466 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 64d
Cleared Jul 30, 2008
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
K081698 · FTA
Image Stream Medical, Inc.
General & Plastic Surgery · 43d
Cleared Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836 · KPR
Carestream Health, Inc.
Radiology · 30d
Cleared Jul 30, 2008
SPSMEDICAL SPORVIEW PA CULTURE SET
K081879 · MRB
Spsmedical Supply Corp.
General Hospital · 28d
Cleared Jul 29, 2008
LIFEPAK 20E
K073089 · MKJ
Physio-Control, Inc.
Cardiovascular · 271d
Cleared Jul 29, 2008
MAESTRO WRIST FRACTURE IMPLANT
K080426 · JWJ
Biomet Manufacturing Corp
Orthopedic · 160d
Cleared Jul 29, 2008
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
K080939 · KMW
W&H Dentalwerk Buermoos GmbH
Dental · 117d
Cleared Jul 29, 2008
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
K081112 · MUJ
Isodose Control B.V.
Radiology · 102d
Cleared Jul 29, 2008
REPROCESSED MASIMO PULSE OXIMETER SENSORS
K081238 · NLF
Ascent Healthcare Solutions
Anesthesiology · 89d
Cleared Jul 29, 2008
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP),...
K081294 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Jul 29, 2008
SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML...
K081524 · FMF
Spectra Medical Devices, Inc.
General Hospital · 57d