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
69025–69048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2004
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
K040834 · HAW
Image-Guided Neurologics, Inc.
Neurology · 64d
Cleared Jun 03, 2004
RESCONTROL II
K040944 · BZD
Resmed, Ltd.
Anesthesiology · 52d
Cleared Jun 03, 2004
COSMEDENT CORE PASTE
K040994 · EBF
Cosmedent, Inc.
Dental · 48d
Cleared Jun 03, 2004
ULTRACLIP II MR
K041201 · GDW
Inrad
General & Plastic Surgery · 27d
Cleared Jun 03, 2004
GOLDEN SPYDER, MODEL GS-300
K041341 · ITI
Golden Technologies, Inc.
Physical Medicine · 14d
Cleared Jun 02, 2004
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE...
K033489 · MBH
Biomet, Inc.
Orthopedic · 211d
Cleared Jun 02, 2004
BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY
K033859 · LLZ
Barco NV Barcoview
Radiology · 174d
Cleared Jun 02, 2004
TOTAL BILIRUBIN REAGENT SET
K040391 · CIG
Pointe Scientific, Inc.,
Chemistry · 106d
Cleared Jun 02, 2004
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
K040642 · CBK
Draeget Medical AG & Co. Kgaa
Anesthesiology · 83d
Cleared Jun 02, 2004
SWIFT ANTERIOR CERVICAL PLATE SYSTEM
K040655 · KWQ
Depuy Spine, Inc.
Orthopedic · 82d
Cleared Jun 02, 2004
SOLARIS D890 THERAPY PROBE
K040729 · ILY
Dynatronics Corp.
Physical Medicine · 72d
Cleared Jun 02, 2004
ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM
K040748 · EHD
Takara Belmont USA, Inc.
Radiology · 71d
Cleared Jun 02, 2004
MODIFICATION TO CAREMATIX WELLNESS SYSTEM
K040966 · DRG
Carematix, Inc.
Cardiovascular · 49d
Cleared Jun 02, 2004
COMBOMAP PRESSURE AND FLOW SYSTEM
K041134 · OBJ
Volcano Therapeutics, Inc.
Cardiovascular · 33d
Cleared Jun 02, 2004
SUMMIT OCT SPINAL SYSTEM
K041203 · MNI
Depuy Spine, Inc.
Orthopedic · 26d
Cleared Jun 02, 2004
SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
K041240 · NRF
Fertility Solutions, Inc.
Hematology · 22d
Cleared Jun 01, 2004
SENSITIVE SKIN ANTIBACTERIAL BANDAGES
K032983 · FRO
Scivolution, Inc.
General & Plastic Surgery · 251d
Cleared Jun 01, 2004
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL,...
K033048 · MHX
Cas Medical Systems, Inc.
Cardiovascular · 246d
Cleared Jun 01, 2004
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
K040395 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 105d
Cleared Jun 01, 2004
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
K040615 · DXC
Advanced Vascular Dynamics
Cardiovascular · 84d
Cleared Jun 01, 2004
MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
K040659 · GEX
Mccue Plc
General & Plastic Surgery · 81d
Cleared Jun 01, 2004
MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
K040713 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 75d
Cleared Jun 01, 2004
EXPORT CATHETER
K040869 · QEZ
Medtronic Vascular
Cardiovascular · 60d
Cleared Jun 01, 2004
NUCLEOTOME PROBE SET, MODEL 21200
K040919 · HRX
Clarus Medical, LLC
Orthopedic · 54d