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
36385–36408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2014
Bi-Portal Bone Graft Delivery Device
K142661 · FMF
Spinal Surgical Strategies, LLC
General Hospital · 84d
Cleared Dec 11, 2014
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
K142800 · DKZ
Co-Innovation Biotech Co., Ltd.
Toxicology · 73d
Cleared Dec 10, 2014
Crystal ®
K133218 · OVE
Spinal Elements, Inc.
Orthopedic · 418d
Cleared Dec 10, 2014
HICURA HAND INSTRUMENTS
K140624 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 274d
Cleared Dec 10, 2014
DISTAL ACCESS TORQUE DEVICE
K141054 · DQX
Distal Access, LLC
Cardiovascular · 236d
Cleared Dec 10, 2014
AMERIWATER OZONE DISINFECTION SYSTEM
K141213 · FIN
Ameriwater
Gastroenterology & Urology · 212d
Cleared Dec 10, 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · MRG
DiaSorin, Inc.
Chemistry · 190d
Cleared Dec 10, 2014
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · MDB
Becton, Dickinson and Company
Microbiology · 156d
Cleared Dec 10, 2014
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)
K142343 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 111d
Cleared Dec 10, 2014
12 mm Endoscopes and Accessories
K142683 · NAY
Intuitive Surgical, Inc.
General Hospital · 82d
Cleared Dec 10, 2014
MD210C3 21.3 Diagnostic Imaging LCD Monitor
K142951 · PGY
Nec Display Solutions , Ltd.
Radiology · 61d
Cleared Dec 10, 2014
Orthofix True Lok Hexapod System VI.3
K143125 · KTT
Orthofix Srl
Orthopedic · 40d
Cleared Dec 10, 2014
AmpliVue Bordetella Assay
K143206 · OZZ
Quidel Corporation
Microbiology · 33d
Cleared Dec 10, 2014
eSie Apps Suite
K143254 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 09, 2014
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
K140224 · LKO
Euroimmun US
Immunology · 314d
Cleared Dec 09, 2014
TOTAL PROTEIN URINE/CSF GEN.3
K141925 · JIQ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Dec 09, 2014
EP NAVIGATOR REL. 5.0
K142126 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 127d
Cleared Dec 09, 2014
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
K142547 · GCJ
Covidien
General & Plastic Surgery · 90d
Cleared Dec 09, 2014
Denali Filter System - Femoral Delivery Kit, Denali Filter System -...
K143208 · DTK
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Dec 09, 2014
H60 V2.00 Diagnostic Ultrasound System
K143264 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Dec 08, 2014
GenPrime Snap-Top Split Key Cup
K140665 · DIS
Genprime, Inc.
Toxicology · 265d
Cleared Dec 08, 2014
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
K140971 · JJY
Randox Laboratories Limited
Chemistry · 236d
Cleared Dec 08, 2014
TWO SKIN TREATMENT SYSTEM
K141507 · GEI
Syneron Medical, Ltd.
General & Plastic Surgery · 185d
Cleared Dec 08, 2014
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS...
K141557 · HRX
Gallini Medical Devices, Srl
Orthopedic · 179d