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
54385–54408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2009
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL,...
K081886 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 219d
Cleared Feb 06, 2009
DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
K081888 · MAX
Spineart
Orthopedic · 219d
Cleared Feb 06, 2009
RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
K081927 · NLF
Renu Medical, Inc.
Anesthesiology · 214d
Cleared Feb 06, 2009
FREEDOM TOTAL KNEE SYSTEM
K082019 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 205d
Cleared Feb 06, 2009
MODEL PC-860 FETAL DOPPLER
K082055 · KNG
Shenzhen Creative Industry Co., Ltd.
Obstetrics & Gynecology · 200d
Cleared CT Feb 06, 2009
CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
K082268 · DQA
Oridion Capnography, Inc.
Anesthesiology · 179d
Cleared Feb 06, 2009
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462 · JGS
Diamond Diagnostics, Inc.
Chemistry · 163d
Cleared Feb 06, 2009
CLEARCORRECT
K082556 · NXC
Clearcorrect, Inc.
Dental · 155d
Cleared Feb 06, 2009
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · MQE
Vitrolife Sweden AB
Obstetrics & Gynecology · 142d
Cleared Feb 06, 2009
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
K082825 · GEX
Energist, Ltd.
General & Plastic Surgery · 134d
Cleared Feb 06, 2009
AWBAT-S, AWBAT-D, AWBAT-M
K082869 · KGN
Aubrey, Inc.
General & Plastic Surgery · 130d
Cleared Feb 06, 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873 · DQX
Medtronic Vascular
Cardiovascular · 130d
Cleared Feb 06, 2009
BIOEMG III
K082927 · KZM
Bio-Research Associates, Inc.
Dental · 128d
Cleared Feb 06, 2009
SMART DILATOR
K082995 · KNQ
Safestitch Medical
Gastroenterology & Urology · 121d
Cleared Feb 06, 2009
CRYOVALVE SG PULMONARY VALVE AND CONDUIT
K083106 · OHA
Cryolife, Inc.
Cardiovascular · 109d
Cleared Feb 06, 2009
TEMPOSIL 2
K083304 · EMA
Coltene/Whaledent AG
Dental · 88d
Cleared Feb 06, 2009
ECHOTIP ULTRA ULTRASOUND NEEDLE
K083330 · FCG
Cook Endoscopy
Gastroenterology & Urology · 86d
Cleared Feb 06, 2009
6F TAIGA GUIDING CATHETER
K083422 · DQY
Medtronic Vascular
Cardiovascular · 79d
Cleared Feb 06, 2009
CORRIDOR FIXATION SYSTEM
K083442 · MRW
Globus Medical, Inc.
Orthopedic · 78d
Cleared Feb 06, 2009
MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL,...
K083447 · HRS
Memometal Technologies
Orthopedic · 77d
Cleared Feb 06, 2009
HI-TORQUE VERSACORE GUIDE WIRE
K083706 · DQX
Abbott Vascular
Cardiovascular · 53d
Cleared Feb 06, 2009
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
K090040 · DQO
Terumo Medical Corp.
Cardiovascular · 31d
Cleared Feb 06, 2009
APLIO ARTIDA V2.0 SSH-880CV
K090158 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Feb 06, 2009
INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
K090159 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 15d