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

Filters: Cleared only ×
176,076 results
65017–65040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2005
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
K052067 · JAF
Multigon Industries, Inc.
Radiology · 28d
Cleared Aug 29, 2005
THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
K052072 · KWQ
Abbott Spine, Inc.
Orthopedic · 28d
Cleared Aug 26, 2005
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K050170 · LYC
Biocomposites, Ltd.
Dental · 212d
Cleared Aug 26, 2005
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
K050399 · MWI
Invivo Research, Inc.
Cardiovascular · 191d
Cleared Aug 26, 2005
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH
K050889 · LJS
Crs Medical Diagnostics, Inc.
General Hospital · 142d
Cleared Aug 26, 2005
STINGRAY EPIDURAL CATHETER CONNECTOR
K051171 · CAZ
Epimed International, Inc.
Anesthesiology · 112d
Cleared Aug 26, 2005
SIJF CANNULATED SCREW SYSTEM
K051296 · OUR
Depuy Spine, Inc.
Orthopedic · 100d
Cleared Aug 26, 2005
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574 · FMF
Nipro Medical Corp.
General Hospital · 73d
Cleared Aug 26, 2005
LUMIWAVE 1X4 INFRARED THERAPY DEVICE
K051816 · ILY
Biocare Systems, Inc.
Physical Medicine · 52d
Cleared Aug 26, 2005
PHILIPS 12-LEAD ALGORITHM
K052049 · DPS
Philips Medical Systems
Cardiovascular · 28d
Cleared Aug 26, 2005
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
K052066 · OLV
Bio-Logic Systems Corp.
Neurology · 25d
Cleared Aug 26, 2005
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
K052101 · KRZ
Roche Diagnostics
Chemistry · 23d
Cleared Aug 25, 2005
REMOTE CARE
K050234 · HGM
E.Care Solutions, Inc.
Obstetrics & Gynecology · 205d
Cleared Aug 25, 2005
SENTINEL IRON LIQUID
K051115 · JIY
Sentinel Ch. Srl
Chemistry · 115d
Cleared Aug 25, 2005
ULTRA HDL
K051962 · LBS
Abbott Laboratories
Chemistry · 37d
Cleared Aug 25, 2005
ASAHI PTCA GUIDE WIRE FIELDER
K052022 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 30d
Cleared Aug 25, 2005
ATB ADVANCE PTA DILATATION CATHETER
K052036 · DQY
Cook, Inc.
Cardiovascular · 28d
Cleared Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052062 · KTT
Alliance Medical Corp.
Orthopedic · 27d
Cleared Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052064 · KTT
Alliance Medical Corp.
Orthopedic · 27d
Cleared Aug 25, 2005
MATRYX INTERFERENCE SCREW
K052080 · HWC
Linvatec Biomaterials, Inc.
Orthopedic · 23d
Cleared Aug 25, 2005
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
K052114 · FGE
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 25, 2005
GR17 DIGITAL DETECTOR
K052136 · MQB
Anrad Corp.
Radiology · 20d
Cleared Aug 25, 2005
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100,...
K052157 · JAK
Ge Medical Systems, LLC
Radiology · 17d
Cleared Aug 24, 2005
OPD-STATION SOFTWARE
K050336 · NCF
Nidek, Inc.
Ophthalmic · 195d