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
49729–49752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2010
INQUIRY AFOCUSII DIAGNOSTIC CATHETER
K101623 · DRF
St Jude Medical
Cardiovascular · 65d
Cleared Aug 13, 2010
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
K102037 · CGA
Apex BioTechnology Corp.
Chemistry · 25d
Cleared Aug 13, 2010
GAUNYING INFRARED LAMP
K102149 · ILY
Foshan Gaunying Electronics Co., Ltd.
Physical Medicine · 14d
Cleared Aug 12, 2010
AESCULAP PEEK CRANIOFIX
K091692 · GXR
Aesculap, Inc.
Neurology · 428d
Cleared Aug 12, 2010
KYPH X HV-R BONE CEMENT
K093828 · NDN
Medtronic, Inc.
Orthopedic · 241d
Cleared Aug 12, 2010
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW...
K100389 · EFB
Handpiece Headquarters
Dental · 177d
Cleared Aug 12, 2010
ORLOCATE SYSTEM MODEL ORL 100
K100551 · LWH
Haldor Advanced Technologies, Ltd.
General & Plastic Surgery · 167d
Cleared Aug 12, 2010
STAINLESS STEEL SPINAL SYSTEM
K100970 · NKB
Theken Spine, LLC
Orthopedic · 126d
Cleared Aug 12, 2010
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
K100977 · LYZ
Jiangsu Sunshine Plastic Products,...
General Hospital · 126d
Cleared Aug 12, 2010
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
K100978 · LYZ
Jiangsu Sunshine Plastic Products,...
General Hospital · 126d
Cleared Aug 12, 2010
AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
K101051 · MAX
Stryker Spine
Orthopedic · 119d
Cleared Aug 12, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND...
K101757 · ITX
Sonosite,Inc.
Radiology · 50d
Cleared Aug 12, 2010
NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'
K101967 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 30d
Cleared Aug 12, 2010
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
K102113 · IYN
Ge Medical Systems China Co., Ltd.
Radiology · 15d
Cleared Aug 11, 2010
ABLATION INSTRUMENT, MODEL 1635
K091310 · GEI
Dfine, Inc.
General & Plastic Surgery · 464d
Cleared Aug 11, 2010
PROTEKTOR 32
K093304 · GWF
Natus Medical, Inc.
Neurology · 294d
Cleared Aug 11, 2010
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
K093692 · NKB
Pioneer Surgical Technology
Orthopedic · 254d
Cleared Aug 11, 2010
COLLAGEN DENTAL MEMBRANE V
K100156 · NPL
Collagen Matrix, Inc.
Dental · 203d
Cleared Aug 11, 2010
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
K100865 · MAX
Stryker Spine
Orthopedic · 135d
Cleared Aug 11, 2010
OMNI III PATIENT MONITOR
K101052 · MWI
Infinium Medical
Cardiovascular · 118d
Cleared Aug 11, 2010
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K101479 · DQY
Reflow Medical
Cardiovascular · 75d
Cleared Aug 11, 2010
WATERLASE MD TURBO PLUS MODEL 7200XXX
K101658 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 61d
Cleared Aug 11, 2010
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
K101660 · DSA
Kepler Medtec
Cardiovascular · 58d
Cleared Aug 11, 2010
HOSPIRA INFUSION BLOOD SETS
K101677 · FPA
Hospira, Inc.
General Hospital · 57d