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
57577–57600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2008
LANX INTERVERTEBRAL BODY FUSION DEVICE
K073144 · MAX
Lanx, LLC
Orthopedic · 78d
Cleared Jan 24, 2008
CRYSTAL
K073351 · ODP
Spinal Elements, Inc.
Orthopedic · 56d
Cleared Jan 24, 2008
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K073441 · QEZ
Possis Medical, Inc.
Cardiovascular · 48d
Cleared Jan 24, 2008
DEPUY SIGMA PS FEMORAL COMPONENTS
K073529 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Jan 24, 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Jan 24, 2008
SKATER BILIARY CATHETER
K073672 · FGE
Angiotech
Gastroenterology & Urology · 28d
Cleared Jan 24, 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024 · MQP
K2m, Inc.
Orthopedic · 20d
Cleared Jan 23, 2008
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS,...
K063223 · HDW
CooperSurgical, Inc.
Obstetrics & Gynecology · 456d
Cleared Jan 23, 2008
JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL...
K071774 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 208d
Cleared Jan 23, 2008
IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4...
K071883 · GEX
Cyden Limited
General & Plastic Surgery · 198d
Cleared Jan 23, 2008
SILK'N
K072906 · GEX
Home Skinovations , Ltd.
General & Plastic Surgery · 104d
Cleared Jan 23, 2008
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
K073014 · ODW
Autogenomics, Incorporated
Toxicology · 90d
Cleared Jan 23, 2008
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING,...
K073018 · IYE
Brainlab AG
Radiology · 90d
Cleared Jan 23, 2008
SELF-ADHESIVE RESIN CEMENT
K073173 · EMA
Dentsply Interntional
Dental · 71d
Cleared Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406 · LON
bioMerieux, Inc.
Microbiology · 50d
Cleared Jan 23, 2008
ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT
K073464 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 44d
Cleared Jan 23, 2008
OPTILITE HOLMIUM LASER FIBERS
K073496 · GEX
Cook Urological, Inc.
General & Plastic Surgery · 42d
Cleared Jan 23, 2008
VERSA LITE
K073503 · FTC
Diomedics, Inc.
General & Plastic Surgery · 41d
Cleared Jan 23, 2008
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K080004 · NZT
Sicel Technologies, Inc.
Radiology · 21d
Cleared Jan 23, 2008
VASCUVIEW ULTRASOUND SYSTEM
K080049 · IYO
Escalon Medical Corp.
Radiology · 15d
Cleared Jan 23, 2008
FLAATZ 750
K080064 · MQB
Drtech Corp.
Radiology · 13d
Cleared Jan 22, 2008
I-PAD
K062970 · MKJ
Cu Medical Systems, Inc.
Cardiovascular · 480d
Cleared Jan 22, 2008
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
K072420 · BSZ
Oceanic Medical Products, Inc.
Anesthesiology · 147d
Cleared Jan 22, 2008
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
K072523 · LBR
General Atomics
Chemistry · 137d