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
46033–46056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2011
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
K112142 · NDW
Siemens Healthcare Diagnostics
Chemistry · 101d
Cleared Nov 04, 2011
ASCENSION NUGRIP CMC IMPLANT
K112278 · KYI
Ascension Orthopedic
Orthopedic · 87d
Cleared Nov 04, 2011
M VISUM ALERT ALARM MANAGEMENT SYSTEM
K112282 · MSX
Mvisum, Inc.
Cardiovascular · 87d
Cleared Nov 04, 2011
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED /...
K112285 · JWH
Tgm Medical, Inc.
Orthopedic · 87d
Cleared Nov 04, 2011
ORTHO-JET CRYSTAL
K112397 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 77d
Cleared Nov 04, 2011
POLY-CHEM 90 ISE MODULE
K112408 · CEM
Polymedco, Inc.
Chemistry · 74d
Cleared Nov 04, 2011
TRIMED CLAVICLE FIXATION SYSTEM
K112509 · HRS
TriMed, Inc.
Orthopedic · 66d
Cleared Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
K112603 · JJX
Beckman Coulter, Inc.
Immunology · 58d
Cleared Nov 03, 2011
FUTURA
K102524 · IMG
Dr. Oliver Wenker, M.D., M.B.A.
Physical Medicine · 427d
Cleared Nov 03, 2011
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K103547 · HQF
Lightmed Corp.
Ophthalmic · 336d
Cleared Nov 03, 2011
BIOHORIZONS ABUTMENTS FOR ZIMMER
K103691 · NHA
BioHorizons Implant Systems, Inc.
Dental · 321d
Cleared Nov 03, 2011
REPROBONE DENTAL GRAFTING MATERIAL
K103820 · LYC
Ceramisys, Ltd.
Dental · 308d
Cleared Nov 03, 2011
THERMO SCIENTIFIC MAS OMNI-CORE
K110738 · JJY
Microgenics Corporation
Chemistry · 231d
Cleared Nov 03, 2011
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K110989 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 209d
Cleared Nov 03, 2011
OPTO MITRA YELLOW LASER
K111643 · HQF
Opto Electronica SA
Ophthalmic · 143d
Cleared Nov 03, 2011
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
K111648 · FCX
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 143d
Cleared Nov 03, 2011
AEQUALIS SHOULDER SYSTEM
K111902 · KWS
Tornier
Orthopedic · 121d
Cleared Nov 03, 2011
ENDOVASCULAR LASER VEIN SYSTEM KIT
K112299 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 85d
Cleared Nov 03, 2011
HI TORQUE CONNECT GUIDEWIRE
K112381 · DQX
Lake Region Medical
Cardiovascular · 78d
Cleared Nov 03, 2011
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20,...
K112945 · KNW
Inrad, Inc.
Gastroenterology & Urology · 30d
Cleared Nov 02, 2011
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI
K102378 · DPS
Vectracor, Inc.
Cardiovascular · 439d
Cleared Nov 02, 2011
MEDICAL MAGGOTS, LESOC
K102827 · NQK
Monarch Labs, LLC
General & Plastic Surgery · 399d
Cleared Nov 02, 2011
DYNA-EXTOR II
K110426 · KTT
Bk Meditech, Co., Ltd.
Orthopedic · 261d
Cleared Nov 02, 2011
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
K110554 · HPZ
Ceramisys, Ltd.
Ophthalmic · 247d