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
43033–43056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627 · MEH
Smith & Nephew, Inc.
Orthopedic · 133d
Cleared Oct 15, 2012
FINGERTIP PULSE OXIMETER
K121697 · DQA
Andon Health Co, Ltd.
Anesthesiology · 130d
Cleared Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K121721 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 125d
Cleared Oct 15, 2012
CAVITY VARNISH
K122331 · LBH
Dentsply International, Inc.
Dental · 74d
Cleared Oct 15, 2012
QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
K122348 · EBI
Recherches Techniques Dentaires (R.T.D.)
Dental · 73d
Cleared Oct 15, 2012
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR...
K122497 · KWQ
Medical Design, LLC
Orthopedic · 60d
Cleared Oct 15, 2012
GRAM POSTITVE CLINDAMYCIN
K122547 · LON
bioMerieux, Inc.
Microbiology · 55d
Cleared Oct 15, 2012
AUTOJECT 2 FOR GLASSY SYRINGE
K122837 · KZH
Owen Mumford, Ltd.
General Hospital · 28d
Cleared Oct 12, 2012
TREGOR DUAL MOBILITY ACETABULAR SYSTEM
K111981 · LZO
Aston Medical
Orthopedic · 458d
Cleared Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199 · LCP
Beckman Coulter, Inc.
Chemistry · 263d
Cleared Oct 12, 2012
UNISYN PLUS HIP STEM
K120595 · LWJ
Consensus Orthopedics, Inc.
Orthopedic · 227d
Cleared Oct 12, 2012
RAPICIDE OPA-28 TEST STRIP
K120652 · JOJ
Serim Research Corp.
General Hospital · 224d
Cleared Oct 12, 2012
ANCHORSURE
K120831 · PBQ
Neomedic International S.L.
Obstetrics & Gynecology · 207d
Cleared Oct 12, 2012
ETEST CEFTAROLINE
K121002 · JWY
bioMerieux, Inc.
Microbiology · 193d
Cleared Oct 12, 2012
COCHLEAR BAHA IMPLANT SYSTEM
K121317 · MAH
Cochlear Americas
Ear, Nose, Throat · 163d
Cleared Oct 12, 2012
ME HAIR2GO
K121598 · ONF
Syneron Medical, Ltd.
General & Plastic Surgery · 134d
Cleared Oct 12, 2012
BIOMET MICROFIXATION NEURO PLATING SYSTEM
K121624 · GWO
Biomet Microfixation
Neurology · 133d
Cleared Oct 12, 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 129d
Cleared Oct 12, 2012
MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
K121688 · NHA
Prismatik Dentalcraft, Inc.
Dental · 127d
Cleared Oct 12, 2012
IFUSE IMPLANT SYSTEM
K122074 · OUR
SI-BONE, Inc.
Orthopedic · 88d
Cleared Oct 12, 2012
PIONEER STERNAL CABLE PLATE SYSTEM
K122293 · HRS
Pioneer Surgical Technology, Inc.
Orthopedic · 73d
Cleared Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
K122398 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 66d
Cleared Oct 12, 2012
AESPIRE 7900, AESPIRE VIEW
K122445 · BSZ
Datex-Ohmeda
Anesthesiology · 63d
Cleared Oct 12, 2012
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
K122574 · IYO
Edan Instruments, Inc.
Radiology · 50d