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
55777–55800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2008
SCULPTURE 2.94 ER:YAG SYSTEM
K073158 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 293d
Cleared Aug 27, 2008
INAREX, MODEL 2D-LX
K080554 · JFB
Inarex Corporation
Physical Medicine · 181d
Cleared Aug 27, 2008
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K080861 · MJN
Micrus Endovascular Corporation
Cardiovascular · 153d
Cleared Aug 27, 2008
BOSTON SCIENTIFIC SURGICAL MESH
K081275 · PAH
Boston Scientific Corp
Gastroenterology & Urology · 114d
Cleared Aug 27, 2008
HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
K081508 · CAW
Shenyang Canta Medical Tech. Co., Ltd.
Anesthesiology · 90d
Cleared Aug 27, 2008
CURBELL PATIENT MONITORING CABLES
K081762 · DSA
Curbell Electronics, Inc.
Cardiovascular · 68d
Cleared Aug 27, 2008
T2 XVBR SPINAL SYSTEM
K082112 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Aug 27, 2008
STRATA NSC BURR HOLE VALVE, MODEL 42335
K082127 · JXG
Medtronic Neurosurgery
Neurology · 29d
Cleared Aug 27, 2008
ROLL-X GUIDEWIRE
K082304 · DQX
St Jude Medical
Cardiovascular · 14d
Cleared Aug 26, 2008
STRYKER ESSX MICRODEBRIDER SYSTEM
K073633 · ERL
Stryker Ireland Ltd., Instruments...
Ear, Nose, Throat · 244d
Cleared Aug 26, 2008
SKINSENSE POLYISOPRENE UNDERGLOVE
K081180 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 123d
Cleared Aug 26, 2008
VOLUMINA
K081215 · LLZ
Kjaya Medical, LLC
Radiology · 118d
Cleared Aug 26, 2008
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 26, 2008
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
K081516 · CBP
Medsource International, LLC
Anesthesiology · 88d
Cleared Aug 26, 2008
SMALL BONE LOCKING PLATING SYSTEM
K081546 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Aug 26, 2008
TAXI ENDOSCOPIC GUIDEWIRE
K081708 · OCY
Lake Region Mfg., Inc.
Gastroenterology & Urology · 70d
Cleared Aug 26, 2008
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
K081726 · NBW
Tyson Bioresearch, Inc.
Chemistry · 69d
Cleared Aug 26, 2008
XIOS PLUS WALL-MODULE
K081903 · MUH
Sirona Dental Systems GmbH
Radiology · 54d
Cleared Aug 26, 2008
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
K082173 · DPS
Cardiac Science Corporation
Cardiovascular · 25d
Cleared Aug 25, 2008
MESACUP MODELS BP180 AND BP230 ELISA KITS
K071961 · OEG
Mbl International Corporation
Immunology · 406d
Cleared Aug 25, 2008
ORTHO ALL-FLEX DIAPHRAGM
K080040 · HDW
Johnson & Johnson Produtos...
Obstetrics & Gynecology · 231d
Cleared Aug 25, 2008
BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
K080761 · DZI
Bonart Co., Ltd.
Dental · 160d
Cleared Aug 25, 2008
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT...
K081237 · EIA
Craftmaster Contour Equipment, Inc.
Dental · 116d
Cleared Aug 25, 2008
TM-400
K081247 · ITH
Ito Co., Ltd.
Physical Medicine · 116d