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
56857–56880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2008
MARIONETTE SA, MODEL 001 001 & 001 002
K072811 · GCJ
Kinetic Surgical, LLC
General & Plastic Surgery · 203d
Cleared Apr 21, 2008
CELL GEN LASER, MODEL CG-4000
K080084 · ILY
Cell Gen Therapeutics, LLC
Physical Medicine · 101d
Cleared Apr 21, 2008
CUTTERSIL ACTIVATOR UNIVERSAL PLUS
K080338 · ELW
Heraeus Kulzer,GmbH
Dental · 74d
Cleared Apr 21, 2008
REGENEREX TIBIAL COMPONENTS
K080361 · MBH
Biomet, Inc.
Orthopedic · 70d
Cleared Apr 21, 2008
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
K080501 · NBW
Taidoc Technology Corporation
Chemistry · 56d
Cleared Apr 21, 2008
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL...
K080507 · KKY
Ceremed , Inc.
General & Plastic Surgery · 56d
Cleared Apr 21, 2008
PLEXUR-P
K080511 · MQV
Osteotech, Inc.
Orthopedic · 56d
Cleared Apr 21, 2008
MODIFICATION TO ENDOFAST RELIANT SYSTEM
K080836 · FTL
Endogun Medical Systems
General & Plastic Surgery · 27d
Cleared Apr 18, 2008
YULEX LATEX POWDER-FREE EXAM GLOVES
K063810 · OIG
Yulex Corporation
General Hospital · 483d
Cleared Apr 18, 2008
VARIOS 75
K071447 · ELC
Nakanishi, Inc.
Dental · 330d
Cleared Apr 18, 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548 · CGS
Teco Diagnostics
Chemistry · 221d
Cleared Apr 18, 2008
50W CERALAS D 1950NM DIODE LASER
K072682 · GEX
Biolitec, Inc.
General & Plastic Surgery · 210d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · LCP
Roche Diagnostics Corp.
Chemistry · 206d
Cleared Apr 18, 2008
3TEST SUPREME GLUCOSE MONITORING SYSTEM
K072905 · NBW
Neuero Engineering, Inc.
Chemistry · 190d
Cleared Apr 18, 2008
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
K073231 · NBW
Lifescan, Inc.
Chemistry · 155d
Cleared Apr 18, 2008
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
K073269 · MNR
Hypnocore, Ltd.
Anesthesiology · 149d
Cleared Apr 18, 2008
MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
K080311 · EBG
Dentsply Interntional
Dental · 72d
Cleared Apr 18, 2008
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
K080757 · DQY
Aga Medical Corp.
Cardiovascular · 31d
Cleared Apr 18, 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K080805 · KWP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Apr 18, 2008
FCR GO PORTABLE DIGITAL X-RAY SYSTEM
K080945 · IZL
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 15d
Cleared Apr 18, 2008
NM APPLICATION SUITE
K080961 · LLZ
Philips Nuclear Medicine, Inc.
Radiology · 14d
Cleared Apr 17, 2008
ISOBAR SEMI-RIGID DUAL DAMPENER
K071261 · NQP
Scient'X
Orthopedic · 349d
Cleared Apr 17, 2008
SIERRA
K072729 · KWP
Seaspine, Inc.
Orthopedic · 204d
Cleared Apr 17, 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904...
K073585 · DQO
Vascular Solutions, Inc.
Cardiovascular · 119d