22 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1422350·14mm H x 22mm W x 35mm L x 0 degrees XLIF
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508451·GENERAL SCISSORS CURVED 9" TUNGSTEN CARBIDE
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741422350·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613043544·Lempert Elevator, Curved, 7mm Blade, Overall Le...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X142235120·14mm H x 22mm W x 35mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X14223580·14mm H x 22mm W x 35mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L142235120·14mm H x 22mm W x 35mm L XLIF Trial 12 degree L...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674142235060·
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ORION ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 22, 2021
PLATE OTIS-C PLUS RIGHT
FDA Adverse Event
Injury
·S.B.M. SAS·Product code HRS·May 21, 2019
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 5, 2014
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015