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
55561–55584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2008
RAYPAX SYSTEM
K081948 · LLZ
Raypax, Inc.
Radiology · 73d
Cleared Sep 19, 2008
TYMPANOSTOMY TUBE
K082188 · ETD
Acclarent, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 19, 2008
ACRYDERM ABSORBENT OXYGEN DRESSING
K082459 · FRO
Acrymed, Inc.
General & Plastic Surgery · 24d
Cleared Sep 19, 2008
MODIFIED ENDO STICH
K082659 · OCW
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 7d
Cleared Sep 18, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
K081451 · NBW
Bionime Corporation
Chemistry · 118d
Cleared Sep 18, 2008
SOMNOWATCH
K081485 · MNR
Somnomedics GmbH
Anesthesiology · 113d
Cleared Sep 18, 2008
INFILTRATION KIT
K081493 · EBC
Dmg USA, Inc.
Dental · 113d
Cleared Sep 18, 2008
ZOLL R SERIES
K081574 · LDD
ZOLL Medical Corporation
Cardiovascular · 105d
Cleared Sep 18, 2008
S40 CREATINE KINASE (CK)
K082226 · JHS
Alfa Wassermann Diagnostic...
Chemistry · 42d
Cleared Sep 18, 2008
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
K082245 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 42d
Cleared Sep 18, 2008
ZENO AI ECO DISC
K082257 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 41d
Cleared Sep 18, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER,...
K082395 · JJX
Bionostics, Inc.
Chemistry · 30d
Cleared Sep 18, 2008
TANDEMHEART TRANSSEPTAL CANNULA- EF 72
K082425 · DWF
Cardiacassist, Inc.
Cardiovascular · 27d
Cleared Sep 18, 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · EOB
Entellus Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 18, 2008
GLIDESHEATH
K082644 · DYB
Terumo Medical Corp.
Cardiovascular · 7d
Cleared Sep 17, 2008
MATRIX RF APPLICATOR
K073572 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 273d
Cleared Sep 17, 2008
OSSEOSPEED TM PROFILE SYSTEM
K080156 · DZE
Astra Tech AB
Dental · 238d
Cleared Sep 17, 2008
CLARO
K080638 · GEX
Clrs Technology Corporation
General & Plastic Surgery · 195d
Cleared Sep 17, 2008
PRIMADO SURGICAL DRILL
K080722 · ERL
Nakanishi, Inc.
Ear, Nose, Throat · 188d
Cleared Sep 17, 2008
VIVASCOPE SYSTEM, MODEL 1500, 3000
K080788 · PSN
Lucid, Inc.
General & Plastic Surgery · 181d
Cleared Sep 17, 2008
G-MOPS G5 SERIES
K081115 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 152d
Cleared Sep 17, 2008
INVENTUS IMPLANT SYSTEM
K081579 · DZE
Inventus Co., Ltd.
Dental · 104d
Cleared Sep 17, 2008
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
K081613 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 100d
Cleared Sep 17, 2008
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
K081705 · EBG
Lang Dental Mfg. Co., Inc.
Dental · 92d