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
60481–60504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2007
SYNTHES ORACLE SPACER
K062933 · MQP
Synthes Spine Co.Lp
Orthopedic · 125d
Cleared Jan 31, 2007
CONMED LINVATEC 24K IRRIGATION SYSTEM
K063326 · HRX
Conmed Linvatec
Orthopedic · 89d
Cleared Jan 31, 2007
ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200
K063472 · IYO
Meda , Ltd.
Radiology · 77d
Cleared Jan 31, 2007
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
K063585 · FDF
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 61d
Cleared Jan 31, 2007
GSO BONE FIXATION FASTENERS
K063589 · HWC
Gold Standard Orthopaedics, LLC
Orthopedic · 61d
Cleared Jan 31, 2007
ENDOGUIDE
K063654 · FDF
Kms Medical, LLC
Gastroenterology & Urology · 54d
Cleared Jan 31, 2007
NEUTRON THERAPY SYSTEM
K063691 · IWL
Northern Illinois Univ. Outreach
Radiology · 50d
Cleared Jan 31, 2007
AXCEL FLOW
K063714 · EBF
Tri Dental Innovators
Dental · 48d
Cleared Jan 31, 2007
DEXTROSCOPE, MODEL MK10
K063730 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 44d
Cleared Jan 31, 2007
VOLUMETRIC TOMOGRAPHY
K063773 · OAS
Instrumentarium Dental, Inc.
Radiology · 41d
Cleared Jan 31, 2007
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
K070017 · NBW
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Jan 31, 2007
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
K070061 · LWJ
Hayes Medical, Inc.
Orthopedic · 26d
Cleared Jan 31, 2007
X3C DIGITAL RADIOGRAPHIC DETECTOR
K070079 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 22d
Cleared Jan 31, 2007
SONOTIP II ULTRASOUND NEEDLE SYSTEM
K070129 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 15d
Cleared Jan 30, 2007
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND...
K063192 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 102d
Cleared Jan 30, 2007
ULTRACLIP II WING AND ULTRACLIP II COIL
K063238 · NEU
Inrad
General & Plastic Surgery · 96d
Cleared Jan 30, 2007
GAMBRO QUICKSET BLOODLINES
K063290 · FJK
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jan 30, 2007
YAG MIR II LASER
K070063 · GEX
Cynosure, Inc.
General & Plastic Surgery · 25d
Cleared Jan 29, 2007
TRIAGE PROTEIN C TEST
K062530 · GGP
Biosite Incorporated
Hematology · 153d
Cleared Jan 29, 2007
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
K062559 · FRO
Laboratoires Urgo
General & Plastic Surgery · 152d
Cleared Jan 29, 2007
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
K062615 · MXZ
Vision Biosystems, Inc.
Pathology · 146d
Cleared Jan 29, 2007
COAGUCHEK XS SYSTEM
K062925 · GJS
Roche Diagnostics Corp.
Hematology · 123d
Cleared Jan 29, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML
K063300 · LON
Becton, Dickinson & CO
Microbiology · 89d
Cleared Jan 29, 2007
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24,...
K063431 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 77d