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
54073–54096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2009
EASYQC - CHEMISTRY WITH ELECTROLYTES
K080404 · JIX
Medica Corp.
Chemistry · 393d
Cleared Mar 13, 2009
OXYGEN DEMAND VALVE
K082345 · CBP
Bpr Medical, Ltd.
Anesthesiology · 210d
Cleared Mar 13, 2009
STONE GRASPING BASKET, MODEL PD-T1 2115
K082735 · GCJ
Sialo Technology, Ltd.
General & Plastic Surgery · 176d
Cleared Mar 13, 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073 · MNI
Theken Spine, LLC
Orthopedic · 149d
Cleared Mar 13, 2009
PICASSO LASER SYSTEM
K083142 · GEX
Amd Lasers, LLC
General & Plastic Surgery · 141d
Cleared Mar 13, 2009
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188 · LJM
Phadia US, Inc.
Immunology · 135d
Cleared Mar 13, 2009
SYMCARE DIABETES MANAGEMENT PROGRAM
K083263 · NBW
Symcare Personalized Health...
Chemistry · 128d
Cleared Mar 13, 2009
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
K083316 · OBO
Topcon Medical Systems, Inc.
Ophthalmic · 123d
Cleared Mar 13, 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR,...
K083463 · JZG
Siemens Healthcare Diagnostics
Immunology · 109d
Cleared Mar 13, 2009
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
K083518 · JPA
Instrumentation Laboratory CO
Hematology · 107d
Cleared Mar 13, 2009
TRILOGY 100 VENTILATOR
K083526 · CBK
Respironics Inc., Sleep & Home...
Anesthesiology · 105d
Cleared Mar 13, 2009
REVELATION STEM, MODEL 427-21/42-080/180
K083651 · KWA
Encore Medical, L.P.
Orthopedic · 94d
Cleared Mar 13, 2009
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K083919 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 72d
Cleared Mar 13, 2009
BEL-CYPHER, MODEL Y977
K090020 · MUH
Takara-Belmont Co., Ltd.
Radiology · 67d
Cleared Mar 13, 2009
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
K090095 · LLZ
Broncus Technologies, Inc.
Radiology · 57d
Cleared Mar 13, 2009
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
K090214 · IYO
Verathon Incorporated
Radiology · 43d
Cleared Mar 13, 2009
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ...
K090229 · IYN
Chang Gung Medical Supplies &...
Radiology · 42d
Cleared Mar 13, 2009
MAGNUM M FIXATION DEVICE
K090380 · MBI
Arthrocare Corp.
Orthopedic · 24d
Cleared Mar 13, 2009
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
K090610 · DRG
Hospira, Inc.
Cardiovascular · 7d
Cleared Mar 12, 2009
HEMOBAND, MODELS HB-NS AND HB-NSXL
K081740 · KOC
Innovations For Access, Inc.
Gastroenterology & Urology · 266d
Cleared Mar 12, 2009
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM
K081813 · HWC
U.S. Implant Solutions, LLC
Orthopedic · 259d
Cleared Mar 12, 2009
SUPERCATH 5
K081953 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 246d
Cleared Mar 12, 2009
ROOT CANAL XR
K083062 · KIF
S & C Polymer GmbH
Dental · 149d
Cleared Mar 12, 2009
ORBITAL RECONSTRUCTIVE IMPLANT II
K083342 · HPZ
Evera Medical, Inc.
Ophthalmic · 120d