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
66985–67008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2005
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
K042345 · DZE
Mondeal Medical Systems GmbH
Dental · 136d
Cleared Jan 13, 2005
VECTORVISION ACL
K042512 · HAW
Brainlab AG
Neurology · 120d
Cleared Jan 13, 2005
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND...
K042567 · KGO
Pt. Medisafe Technologies
General Hospital · 114d
Cleared Jan 13, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K042602 · MQB
Ge Medical Systems, LLC
Radiology · 111d
Cleared Jan 13, 2005
ALOCLAIR ORAL SPRAY
K042722 · OLR
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 104d
Cleared Jan 13, 2005
CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
K042849 · DQK
Cardiobiomedical Corporation
Cardiovascular · 90d
Cleared Jan 13, 2005
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
K042879 · LZA
Sgmp Co., Ltd.
General Hospital · 87d
Cleared Jan 13, 2005
MEDICON VIPAIR HIGH SPEED SYSTEM
K042974 · HBB
Medicon EG
Neurology · 77d
Cleared Jan 13, 2005
ICSI-100
K043116 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 64d
Cleared Jan 13, 2005
SPSMEDICAL SPORVIEW PA CULTURE SET
K043135 · MRB
Spsmedical Supply Corp.
General Hospital · 62d
Cleared Jan 13, 2005
ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
K043226 · DZE
Imtec Corp.
Dental · 52d
Cleared Jan 13, 2005
ANEROID SPHYGMOMANOMETER, MODEL BK2002
K043286 · DXQ
Wenzhou Bokang Instrument Co.,Ltd
Cardiovascular · 48d
Cleared Jan 13, 2005
MIRAGE, RELEASE 5.5
K043441 · KPS
Segami Corporation
Radiology · 30d
Cleared Jan 13, 2005
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
K043524 · IYN
B & K Medical A/S
Radiology · 24d
Cleared Jan 13, 2005
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
K043557 · EHD
Panoramic Corp.
Radiology · 17d
Cleared Jan 13, 2005
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K050034 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 6d
Cleared Jan 12, 2005
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 380d
Cleared Jan 12, 2005
FLOWMEDIC, MODEL 220
K042217 · JOW
Flowmedic (Israel), Ltd.
Cardiovascular · 149d
Cleared Jan 12, 2005
ODYSSEY
K042861 · MUJ
Permedics, Inc.
Radiology · 89d
Cleared Jan 12, 2005
SMITH & NEPHEW HYBRID KNEE FEMORAL
K042896 · NPJ
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Jan 12, 2005
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
K042993 · JWH
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Jan 12, 2005
BRAINET KIT
K043009 · GXY
Jordan Neuroscience, Inc.
Neurology · 72d
Cleared Jan 12, 2005
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC...
K043129 · LPL
Opti-Centre Laboratories
Ophthalmic · 61d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262 · LNH
Ge Healthcare
Radiology · 49d