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
57073–57096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2008
COBAS LITHIUM
K063684 · NDW
Roche Diagnostics Corp.
Toxicology · 465d
Cleared Mar 21, 2008
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
K072369 · NBW
Hmd Biomedical, LLC
Chemistry · 211d
Cleared Mar 21, 2008
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR...
K072406 · LYY
Sgmp Co., Ltd.
General Hospital · 207d
Cleared Mar 21, 2008
JIERUI SYRINGES AND NEEDLES
K072739 · MEG
Shandong Weigao Group Medical Polymer...
General Hospital · 176d
Cleared Mar 21, 2008
ZIEHM VISION 2
K073346 · JAK
Ziehm Imaging, Inc.
Radiology · 113d
Cleared Mar 21, 2008
SURGISIS BIODESIGN TISSUE GRAFT
K073391 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 109d
Cleared Mar 21, 2008
VIRTUAL PORTS ENDOCLEAR SYSTEM
K080051 · GCJ
Virtual Ports, Ltd.
General & Plastic Surgery · 73d
Cleared Mar 21, 2008
MANDREL GUIDEWIRES OR M-WIRE
K080508 · OCY
Lake Region Medical
Gastroenterology & Urology · 25d
Cleared Mar 21, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K080640 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared Mar 21, 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
K080680 · NEW
Surgical Specialties Corp
General & Plastic Surgery · 11d
Cleared Mar 20, 2008
SLEEP QUALITY
K070855 · MNR
Dynadx Corporation
Anesthesiology · 358d
Cleared Mar 20, 2008
CLARIVEIN CATHETER
K071468 · KRA
Vascular Insights, LLC
Cardiovascular · 296d
Cleared Mar 20, 2008
COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX
K071694 · CBI
Daiken Medical Co, Ltd.
Anesthesiology · 274d
Cleared Mar 20, 2008
SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
K072116 · NKB
Neurospine Innovations and Solutions
Orthopedic · 232d
Cleared Mar 20, 2008
AAP BONE PLATES AND SCREW IMPLANTS
K072411 · HRS
Aap Implantate AG
Orthopedic · 206d
Cleared Mar 20, 2008
RESPIRONICS GOLOX
K072723 · BYJ
Respironics, Inc.
Anesthesiology · 176d
Cleared Mar 20, 2008
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
K073227 · MNW
Aiia Communication, Inc.
Gastroenterology & Urology · 126d
Cleared Mar 20, 2008
PSS SYSTEM
K073240 · MNI
Spinal USA
Orthopedic · 125d
Cleared Mar 20, 2008
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
K073363 · LGZ
Paladin Biomedical Corporation
General Hospital · 111d
Cleared Mar 20, 2008
MODULAR FOOT SYSTEM
K073624 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 85d
Cleared Mar 20, 2008
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
K073637 · KWA
Biomet Manufacturing Corp
Orthopedic · 85d
Cleared Mar 20, 2008
SWIFT LT
K073638 · BZD
Resmed, Ltd.
Anesthesiology · 85d
Cleared Mar 20, 2008
ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE...
K073652 · EFB
Nakamura Magnifier Co., Ltd.
Dental · 85d
Cleared Mar 20, 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d