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
36889–36912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2014
SYNGO CT SINGLE SOURCE DUAL ENERGY
K133677 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 321d
Cleared Oct 16, 2014
ELEVATION
K140023 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 283d
Cleared Oct 16, 2014
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
K140543 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 226d
Cleared Oct 16, 2014
PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
K140598 · NHJ
Dima Italia Srl
Anesthesiology · 220d
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 125d
Cleared Oct 16, 2014
AQUARIUS NASAL FEEDING TUBE
K141753 · PIF
Degania Silicone , Ltd.
Gastroenterology & Urology · 108d
Cleared Oct 16, 2014
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · MCW
Covidien, LLC
Cardiovascular · 105d
Cleared Oct 16, 2014
DX-D IMAGING PACKAGE
K142184 · MQB
Agfa Healthcare N.V.
Radiology · 69d
Cleared Oct 16, 2014
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test...
K142280 · DJG
Healgen Scientific, LLC
Chemistry · 62d
Cleared Oct 16, 2014
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound...
K142618 · ITX
Hitachi Aloka Medical America, Inc.
Radiology · 30d
Cleared Oct 16, 2014
G-Lok and G-Lok XL Extender
K142653 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 28d
Cleared Oct 15, 2014
MULTIPULSE HOPLUS
K131987 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 474d
Cleared Oct 15, 2014
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
K134009 · FTC
Medtek Lighting
General & Plastic Surgery · 289d
Cleared Oct 15, 2014
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K140025 · LPL
Pegavision Corporation
Ophthalmic · 282d
Cleared Oct 15, 2014
OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER,...
K140470 · GEX
Oberon GmbH Fiber Technologies
General & Plastic Surgery · 232d
Cleared Oct 15, 2014
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776 · NEW
Ethicon, Inc.
General & Plastic Surgery · 105d
Cleared Oct 15, 2014
DANA
K141865 · LQD
Anthrotronix, Inc.
Neurology · 97d
Cleared Oct 15, 2014
XCEL 455 SLIT LAMP
K141954 · HJO
Reichert, Inc.
Ophthalmic · 89d
Cleared Oct 15, 2014
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K142095 · OVD
Renovis Surgical Technologies, Inc.
Orthopedic · 75d
Cleared Oct 15, 2014
COGENT MED-LIF XL
K142193 · MAX
Cogent Spine, LLC
Orthopedic · 65d
Cleared Oct 15, 2014
Urine/CSF Albumin, Urine/CSF Albumin Calibrator
K142346 · DCF
Beckman Coulter Ireland, Inc.
Chemistry · 54d
Cleared Oct 14, 2014
JULIET PO
K142277 · MAX
Spineart
Orthopedic · 60d
Cleared Oct 14, 2014
PICC Maximal Barrier Nursing Kit
K142616 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Oct 10, 2014
HS NOTA
K131925 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 471d