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
52993–53016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2009
MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
K083644 · OLO
Mako Surgical Corp.
Orthopedic · 192d
Cleared Jun 19, 2009
SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500,...
K083753 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 184d
Cleared Jun 19, 2009
DSS STABILIZATION SYSTEM
K090099 · NKB
Paradigm Spine, LLC
Orthopedic · 155d
Cleared Jun 19, 2009
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
K090621 · DXT
Flowcardia, Inc.
Cardiovascular · 102d
Cleared Jun 19, 2009
NUVANT CARDIAC EVENT MONITORING SYSTEM
K090696 · QYX
Corventis, Inc.
Cardiovascular · 95d
Cleared Jun 19, 2009
CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM
K090962 · GEX
Quanta System Spa
General & Plastic Surgery · 74d
Cleared Jun 19, 2009
VASCUTEK BRANCHED GELWEAVE
K090987 · DSY
Vascutek, Ltd.
Cardiovascular · 73d
Cleared Jun 19, 2009
AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
K091038 · NRB
Arobella Medical, LLC
General & Plastic Surgery · 67d
Cleared Jun 19, 2009
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION...
K091504 · MJN
Micrus Endovascular Corporation
Cardiovascular · 29d
Cleared Jun 19, 2009
JETSTREAM G2 NXT SYSTEM, MODEL PV20300
K091509 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 28d
Cleared Jun 19, 2009
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
K091551 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 23d
Cleared Jun 19, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K091680 · ITX
Edan Instruments, Inc.
Radiology · 9d
Cleared Jun 18, 2009
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
K080941 · DSB
N.I. Medical, Ltd.
Cardiovascular · 441d
Cleared Jun 18, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
K083305 · LZC
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 220d
Cleared Jun 18, 2009
PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01,...
K090167 · KKO
Philips Electronics UK Limited
Dental · 147d
Cleared Jun 18, 2009
ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT
K090306 · GEI
Aragon Surgical, Inc.
General & Plastic Surgery · 132d
Cleared Jun 18, 2009
DDI ULTRASONIC NEBULIZER SYSTEM
K090307 · CAF
Diagnostic Devices, Inc.
Anesthesiology · 132d
Cleared Jun 18, 2009
CAMLOG ABUTMENTS PS
K090347 · NHA
Altatec GmbH
Dental · 127d
Cleared Jun 18, 2009
SYNTEC ORTHODONTIC MINI SCREW
K090476 · OAT
Syntec Scientific Corp.
Dental · 114d
Cleared Jun 18, 2009
ARTIS ZEE / ZEEGOS WITH SW VC14
K090745 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jun 18, 2009
KENS INTERNAL FIXATION SYSTEM
K090786 · HRS
Kens Finemedtech Sdn. Bhd
Orthopedic · 87d
Cleared Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT...
K090939 · DKB
Roche Diagnostics
Chemistry · 76d
Cleared Jun 18, 2009
INOMAX DS (DELIVERY SYSTEM)
K090958 · MNR
Ino Therapeutics, LLC
Anesthesiology · 73d
Cleared Jun 18, 2009
PIGGYBACK WIRE CONVERTER
K090977 · DQY
Vascular Solutions, Inc.
Cardiovascular · 73d