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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
39625–39648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2013
HARVESTING CANNULA
K132743 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 91d
Cleared Dec 03, 2013
AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4...
K132974 · GEI
Medtronic Advanced Energy, LLC
General & Plastic Surgery · 71d
Cleared Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
K133181 · LLZ
Jvckenwood Corporation
Radiology · 47d
Cleared Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
K133185 · LLZ
Jvckenwood Corporation
Radiology · 47d
Cleared Dec 03, 2013
HEM-O-LOK LIGATING CLIP
K133202 · FZP
Teleflex Medical
General & Plastic Surgery · 47d
Cleared Dec 03, 2013
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
K133314 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 36d
Cleared Dec 02, 2013
SONIXGPS
K121812 · BSP
Ultrasonix Medical Corporation
Anesthesiology · 530d
Cleared Dec 02, 2013
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON...
K130512 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 278d
Cleared Dec 02, 2013
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 144d
Cleared Dec 02, 2013
COBAS CT/NG V2.0 TEST
K132270 · LSL
Roche Molecular Systems, Inc.
Microbiology · 133d
Cleared Dec 02, 2013
KINSA SMART THERMOMETER
K132514 · FLL
Kinsa, Inc.
General Hospital · 112d
Cleared Dec 02, 2013
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE...
K132896 · MQX
Asia-Med GmbH and CO KG
General Hospital · 77d
Cleared Dec 02, 2013
1ST MTP PLATE
K133437 · HRS
Osteomed
Orthopedic · 25d
Cleared Nov 29, 2013
INOMAX DSIR (DELIVERY SYSTEM)
K131686 · MRN
Ino Therapeutics/Ikaria
Anesthesiology · 172d
Cleared Nov 29, 2013
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726 · OZN
Primeradx
Microbiology · 91d
Cleared Nov 29, 2013
PIEZOSURGERY FLEX
K132848 · JDX
Mectron S.P.A.
Orthopedic · 79d
Cleared Nov 29, 2013
LESSRAY
K132970 · OWB
Saferay Spine, LLC
Radiology · 67d
Cleared Nov 29, 2013
TRANQUILL BARBED DEVICE
K133420 · NEW
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 21d
Cleared Nov 27, 2013
SPECULAR MICROSCOPE CEM-530
K130565 · NQE
Nidek Co., Ltd.
Ophthalmic · 268d
Cleared Nov 27, 2013
ROGS
K131016 · CAW
Molecular Products , Ltd.
Anesthesiology · 230d
Cleared Nov 27, 2013
ARCHON ANTERIOR CERVICAL PLATE SYSTEM
K131025 · KWQ
Nuvasive, Inc.
Orthopedic · 229d
Cleared Nov 27, 2013
GENESIS LED WANDS
K131142 · GEX
Genesis Biosystems, Inc.
General & Plastic Surgery · 218d
Cleared Nov 27, 2013
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC...
K131383 · GWQ
Advanced Brain Monitoring, Inc.
Neurology · 197d
Cleared Nov 27, 2013
JUSHA-M52C MEDICAL DISPLAY
K131390 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 197d