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
45697–45720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2011
TERUMO ASPRIATION CATHETER
K112382 · QEZ
Terumo Medical Corporation
Cardiovascular · 118d
Cleared Dec 14, 2011
ULTRAMAXO2 OXYGEN ANALYER
K112402 · CCL
Maxtec, LLC
Anesthesiology · 114d
Cleared Dec 14, 2011
VENUS PEARL PLT REFILL A1
K112501 · EBF
Heraeus Kulzer, LLC
Dental · 106d
Cleared Dec 14, 2011
SMI CARDIOVASCULAR PACH
K112683 · DXZ
Solimas Medical, Inc.
Cardiovascular · 90d
Cleared Dec 13, 2011
SOMNOBRUX SPLINTS
K102909 · MQC
Somnomed, Inc.
Dental · 438d
Cleared Dec 13, 2011
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
K103161 · DJG
Omega Laboratories, Inc.
Toxicology · 412d
Cleared Dec 13, 2011
VBB SYSTEM
K110604 · NDN
Synthes
Orthopedic · 285d
Cleared Dec 13, 2011
PRECISION SKIN EMULSION
K111168 · FRO
Precision Dermatology Incorporated
General & Plastic Surgery · 232d
Cleared Dec 13, 2011
STAXX(R) XD SYSTEM
K111418 · MQP
Spine Wave, Inc.
Orthopedic · 207d
Cleared Dec 13, 2011
VIEW 1 IMAGING
K112480 · LLZ
KARL STORZ Endoscopy-America, Inc.
Radiology · 106d
Cleared Dec 13, 2011
HEADLESS COMPRESSION SCREW
K112672 · HWC
Skeletal Dynamics, LLC
Orthopedic · 90d
Cleared Dec 13, 2011
INTERFACE BONE VOID FILLER
K112857 · MQV
Biostructures, LLC
Orthopedic · 74d
Cleared Dec 13, 2011
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
K113034 · IZI
Ge Healthcare
Radiology · 63d
Cleared Dec 13, 2011
SYNTHES HEMOSTATIC BONE PUTTY
K113079 · MTJ
Synthes (Usa) Products, LLC/Norian...
General & Plastic Surgery · 57d
Cleared Dec 13, 2011
COUGAR SYSTEM
K113348 · MAX
Johnson & Johnson
Orthopedic · 29d
Cleared Dec 13, 2011
TARGET DETACHABLE COIL
K113412 · HCG
Stryker Neurovascular
Neurology · 25d
Cleared Dec 12, 2011
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425 · MID
Zeus Scientific, Inc.
Immunology · 474d
Cleared Dec 12, 2011
XINGTM SPINE SYSTEM
K111995 · MNH
Implanova Co., Ltd.
Orthopedic · 152d
Cleared Dec 12, 2011
SYNTHES ZERO-P
K112459 · OVE
Synthes Spine Co.Lp
Orthopedic · 108d
Cleared Dec 12, 2011
OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
K112658 · HWC
Osteospring Medical, Inc.
Orthopedic · 90d
Cleared Dec 12, 2011
ARROW-LOK DIGITAL SYSTEM
K112675 · HTY
Arrowhead Medical Device...
Orthopedic · 89d
Cleared Dec 12, 2011
SPACER-S
K112983 · HSD
Tecres S.P.A.
Orthopedic · 67d
Cleared Dec 12, 2011
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
K113102 · MUJ
Nucletron
Radiology · 54d
Cleared Dec 12, 2011
CELLTRACKS ANALYER II
K113181 · NQI
Veridex, LLC
Pathology · 45d