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
67513–67536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2004
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · GXR
Synthes (Usa)
Orthopedic · 19d
Cleared Nov 17, 2004
SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
K043008 · GEI
Surgrx, Inc.
General & Plastic Surgery · 16d
Cleared Nov 17, 2004
OMNIPULSE MINI, MODEL 2120
K043012 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 15d
Cleared Nov 17, 2004
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
K043078 · IYO
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Nov 16, 2004
HYDROGEL CANALICULAR PLUG
K040912 · LZU
Partners IN Biomaterials, Inc.
Ophthalmic · 222d
Cleared Nov 16, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K041443 · LZO
Osteoimplant Technology, Inc.
Orthopedic · 168d
Cleared Nov 16, 2004
RESTITU
K041937 · IYE
Resonant Medical, Inc.
Radiology · 120d
Cleared Nov 16, 2004
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083 · HNO
Biovision AG
Ophthalmic · 105d
Cleared Nov 16, 2004
MULTI-CHEM CALIBRATOR A
K042551 · JIX
Wako Chemicals USA, Inc.
Chemistry · 57d
Cleared Nov 16, 2004
ORTHOFIX VOLAR DISTAL RADIAL PLATE
K042766 · HRS
Orthofix, Inc.
Orthopedic · 42d
Cleared Nov 16, 2004
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · LPL
CooperVision, Inc.
Ophthalmic · 35d
Cleared Nov 16, 2004
MICROVERTER URETERAL ACCESS SHEATH
K042877 · KNY
Percutaneous Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 16, 2004
DYNAMOMETER - MODEL FCE AND MODEL MSC
K042889 · LBB
Ametek
Neurology · 28d
Cleared Nov 16, 2004
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
K042895 · KTT
Synthes (Usa)
Orthopedic · 27d
Cleared Nov 16, 2004
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
K043016 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Nov 15, 2004
STERICHEK GLUTARALDEHYDE REAGENT STRIPS
K040660 · LIF
Hach Company
Gastroenterology & Urology · 248d
Cleared Nov 15, 2004
MILLENIUM, MODELS 2000, 2001 AND 2002
K041007 · CBF
Hyperbaric For Life, LLC
Anesthesiology · 210d
Cleared Nov 15, 2004
MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
K041852 · CCW
Minrad, Inc.
Anesthesiology · 130d
Cleared Nov 15, 2004
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
K041951 · LLH
Remel, Inc.
Microbiology · 118d
Cleared Nov 15, 2004
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
K042197 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 94d
Cleared Nov 15, 2004
D3 CHROMA
K042422 · DYH
Sybron Dental Specialties, Inc.
Dental · 69d
Cleared Nov 15, 2004
THE 5.0 X 6.0MM DENTAL IMPLANT
K042637 · DZE
Bicon, Inc.
Dental · 49d
Cleared Nov 15, 2004
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
K042682 · BTM
Ambu, Inc.
Anesthesiology · 47d
Cleared Nov 15, 2004
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
K042733 · LHO
Standard Imaging, Inc.
Radiology · 45d