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
73897–73920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2003
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
K022622 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 155d
Cleared Jan 09, 2003
NIKOMED TRACE 1 ECG ELECTRODES
K022909 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 128d
Cleared Jan 09, 2003
PACSPLUS
K023460 · LLZ
Medical Standard Co., Ltd.
Radiology · 86d
Cleared Jan 09, 2003
REMECURE MODEL CL 15E
K023652 · EBZ
Remedent NV
Dental · 71d
Cleared Jan 09, 2003
PERFORMA STEREO
K023864 · IZH
Instrumentarium Corp. Imaging Division
Radiology · 50d
Cleared Jan 09, 2003
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
K023960 · DXG
Lidco, Ltd.
Cardiovascular · 41d
Cleared Jan 09, 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared Jan 09, 2003
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
K024095 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 09, 2003
BD INSULIN SYRINGE
K024112 · FMF
Becton, Dickinson & CO
General Hospital · 27d
Cleared Jan 09, 2003
QWH-250-PAN WRIST ARRAY COIL
K024209 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Jan 09, 2003
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH...
K024292 · LYY
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Jan 09, 2003
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
K024352 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Jan 09, 2003
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
K024354 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Jan 08, 2003
LAD, MODEL LAD-01
K021222 · GEX
Norwood Abbey , Ltd.
General & Plastic Surgery · 266d
Cleared Jan 08, 2003
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
K021694 · DTQ
Cardiovention, Inc.
Cardiovascular · 231d
Cleared Jan 08, 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
K022272 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 177d
Cleared Jan 08, 2003
MICROVISION SCLERAL BUCKLING COMPONENTS
K023481 · HQX
Microvision, Inc.
Ophthalmic · 83d
Cleared Jan 08, 2003
SMARTTROAE
K023859 · EWO
Intelligent Hearing Systems
Ear, Nose, Throat · 49d
Cleared Jan 08, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
K023895 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jan 08, 2003
ERBE VIO APC WITH ACCESSORIES
K024047 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 30d
Cleared Jan 08, 2003
MBC SERIES
K024059 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 30d
Cleared Jan 08, 2003
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
K024069 · DWF
Medtronic Vascular
Cardiovascular · 29d
Cleared Jan 08, 2003
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K024294 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 15d
Cleared Jan 07, 2003
SPECATH CENTRAL VENOUS CATHETER KITS
K021130 · FOZ
Special Medical Co. , Ltd.
General Hospital · 273d