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
48433–48456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2011
COMPACT PIEZO P2K, POWERCARE
K102218 · ELC
Mectron S.P.A.
Dental · 171d
Cleared Jan 24, 2011
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS
K102336 · BWH
Boston Scientific Corporation
Ear, Nose, Throat · 159d
Cleared Jan 24, 2011
TOTAL SHOULDER SYSTEM
K102670 · KWS
Shoulder Innovations, LLC
Orthopedic · 130d
Cleared Jan 24, 2011
DISPOSABLE PROPHY ANGLE
K103157 · EGS
Angstrom Mfg., Inc.
Dental · 90d
Cleared Jan 24, 2011
KYPHON INFLATION SYRINGE
K103231 · HRX
Medtronic Spine, LLC
Orthopedic · 84d
Cleared Jan 24, 2011
APTUS ULNA PLATES
K103332 · HRS
Medartis AG
Orthopedic · 73d
Cleared Jan 21, 2011
ENDOSERTER
K090626 · OTZ
Ocular Systems, Inc.
Ophthalmic · 683d
Cleared Jan 21, 2011
LIPOCONTROL
K090754 · ORK
Osyris Medical
General & Plastic Surgery · 672d
Cleared Jan 21, 2011
MAGO 4S
K093101 · LFX
Diamedix Corp.
Microbiology · 477d
Cleared Jan 21, 2011
REALEYE MODEL VCPS
K100625 · IYE
Navotek Medical, Ltd.
Radiology · 323d
Cleared Jan 21, 2011
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN...
K100957 · CAW
Pacific Consolidated Industries, LLC
Anesthesiology · 289d
Cleared Jan 21, 2011
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
K101147 · NUV
Alma Lasers, Inc.
General & Plastic Surgery · 273d
Cleared Jan 21, 2011
FETCH 2 ASPIRATION CATHETER MODEL 109400-001
K101354 · QEZ
Medrad Interventional/Possis
Cardiovascular · 252d
Cleared Jan 21, 2011
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
K101894 · ILY
Bioremedi Therapeutic Systems, Inc.
Physical Medicine · 198d
Cleared Jan 21, 2011
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL,...
K102154 · HQD
The Lagado Corp.
Ophthalmic · 175d
Cleared Jan 21, 2011
INFA WARMER I
K102227 · FMT
Atom Medical Corporation
General Hospital · 165d
Cleared Jan 21, 2011
HAMILTON-C2
K102775 · CBK
Hamilton Medical AG
Anesthesiology · 119d
Cleared Jan 21, 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · MNH
Exactech, Inc.
Orthopedic · 113d
Cleared Jan 21, 2011
LOW ADHERENT AFM AG DRESSINGS
K103141 · FRO
Milliken Healthcare Products, LLC
General & Plastic Surgery · 88d
Cleared Jan 21, 2011
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
K103243 · HRS
Synthes (Usa)
Orthopedic · 81d
Cleared Jan 21, 2011
LIAISON XL ANALYZER MODEL 10050
K103529 · LOL
DiaSorin, Inc.
Microbiology · 51d
Cleared Jan 21, 2011
GRANDIO SO FLOW
K103580 · EBF
Voco GmbH
Dental · 46d
Cleared Jan 21, 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3...
K103746 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Jan 21, 2011
TAPERLOC COMPLETE, SIZE 5 AND 6
K103755 · KWA
Biomet Manufacturing Corp
Orthopedic · 29d