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
59377–59400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2007
NORAS OR HEAD HOLDER
K071179 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Jun 13, 2007
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT...
K071203 · LPN
Optikem International, Inc.
Ophthalmic · 43d
Cleared Jun 13, 2007
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
K071376 · NKB
Vertebron, Inc.
Orthopedic · 27d
Cleared Jun 13, 2007
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
K071378 · JAK
E-Z-Em, Inc.
Radiology · 27d
Cleared Jun 13, 2007
X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR
K071408 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 23d
Cleared Jun 13, 2007
MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE...
K071426 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 21d
Cleared Jun 13, 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · HBL
Integra LifeSciences Corporation
Neurology · 19d
Cleared Jun 12, 2007
THERMAGE THERMACOOL SYSTEM
K052936 · GEI
Thermage, Inc.
General & Plastic Surgery · 601d
Cleared Jun 12, 2007
ULTRAEZ DESENSITIZING GEL
K061438 · LBH
Ultradent Products, Inc.
Dental · 384d
Cleared Jun 12, 2007
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K062737 · CGS
Horiba Abx
Chemistry · 272d
Cleared Jun 12, 2007
MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY
K071069 · BZD
Viasys Sleep Systems, LLC
Anesthesiology · 57d
Cleared Jun 11, 2007
REVOIS IMPLANT SYSTEM
K063106 · NHA
Curasan AG
Dental · 243d
Cleared Jun 11, 2007
BC-3200 AUTO HEMATOLOGY ANALYZER
K063407 · GKZ
Shenzhen Mindray Bio-Medical...
Hematology · 214d
Cleared Jun 11, 2007
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
K063498 · OBZ
Sebia
Immunology · 203d
Cleared Jun 11, 2007
ISSYS LP SPINAL FIXATION SYSTEM
K070281 · NKB
Custom Spine, Inc.
Orthopedic · 133d
Cleared Jun 11, 2007
VITALSTIM EXPERIA
K070425 · IPF
Chattanooga Group
Physical Medicine · 118d
Cleared Jun 11, 2007
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL...
K070453 · GHH
Olympus Life & Material Science...
Hematology · 115d
Cleared Jun 11, 2007
ALLEZ SPINE CROSS CONNECTORS
K070460 · NKB
Allez Spine, LLC
Orthopedic · 115d
Cleared Jun 11, 2007
LRTM SURGICAL MESH
K070560 · FTM
Lifecell Corp.
General & Plastic Surgery · 104d
Cleared Jun 11, 2007
ALTIVA CLASSIC ACP SYSTEM
K070891 · KWQ
Altiva Corp.
Orthopedic · 73d
Cleared Jun 11, 2007
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
K071153 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 47d
Cleared Jun 11, 2007
MODIFICATION TO: INTERPLATE VBR SYSTEM
K071372 · MQP
Rsb Spine, LLC
Orthopedic · 26d
Cleared Jun 11, 2007
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
K071403 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 21d
Cleared Jun 08, 2007
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
K062484 · CAF
Flaem Nuova S.P.A.
Anesthesiology · 287d