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
58561–58584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2007
GS SYSTEM
K063861 · DZE
Osstem Implant Co., Ltd.
Dental · 267d
Cleared Sep 21, 2007
MODIFICATION TO PASSMED SPINAL SYSTEM
K070276 · MNI
Medicrea Technologies
Orthopedic · 235d
Cleared Sep 21, 2007
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
K070291 · FMZ
Medix I.C.S.A.
General Hospital · 234d
Cleared Sep 21, 2007
MULTIPLE BRAND MALE LATEX CONDOM
K070937 · HIS
Nulatex Sdn. Bhd.
Obstetrics & Gynecology · 170d
Cleared Sep 21, 2007
APEXNRG-BLUE ELECTRONIC APEX LOCATOR
K071133 · LQY
Medicnrg , Ltd.
Dental · 151d
Cleared Sep 21, 2007
GLOBUS GENESY 1100 STIMULATOR
K071431 · IPF
Domino S.R.L.
Physical Medicine · 121d
Cleared Sep 21, 2007
PLANET 55
K071472 · MWI
Larsen & Toubro Limited
Cardiovascular · 115d
Cleared Sep 21, 2007
FIXAFLOSS
K071615 · EEF
Sybron Dental Specialties, Inc.
Dental · 100d
Cleared Sep 21, 2007
MODIFICATION TO: UNITY NETWORK ID
K071982 · MWI
Ge Medical Systems Information...
Cardiovascular · 64d
Cleared Sep 21, 2007
ZIP'R PC
K072224 · ITI
Global Fabtech Wheelchair (Shanghai)...
Physical Medicine · 42d
Cleared Sep 21, 2007
PLANMECA PROONE
K072244 · MUH
Planmeca Oy
Radiology · 39d
Cleared Sep 21, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K072279 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Sep 21, 2007
TILITE AERO X
K072311 · IOR
Tisport, LLC
Physical Medicine · 35d
Cleared Sep 21, 2007
POWRSYRINGE INJECTOR
K072318 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 32d
Cleared Sep 21, 2007
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
K072337 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 32d
Cleared Sep 21, 2007
CERVITEC PLUS
K072338 · LBH
Ivoclar Vivadent, Inc.
Dental · 32d
Cleared Sep 21, 2007
POWRSYRINGE MONITOR
K072345 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 31d
Cleared Sep 21, 2007
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K072384 · MQV
Kensey Nash Corp.
Orthopedic · 28d
Cleared Sep 21, 2007
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K072504 · IYE
Accuray Incorporated
Radiology · 15d
Cleared Sep 21, 2007
VISULAS TRION
K072514 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 14d
Cleared Sep 20, 2007
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
K061539 · HFX
Clinical Innovations, LLC
Obstetrics & Gynecology · 472d
Cleared Sep 20, 2007
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
K063297 · HQF
Lightmed Corp.
Ophthalmic · 323d
Cleared Sep 20, 2007
P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)
K070478 · NHA
Straumann Manufacturing, Inc.
Dental · 212d
Cleared Sep 20, 2007
ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
K071439 · DZE
Zimmer Dental, Inc.
Dental · 120d