17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Disposable Endoscopy Valve Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sonic
FDA UDI
Sbo Hearing A/S·05714464093700·SONIC ENCHANT SE 10 MNR DG
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197533591·Zlider SPURLING RONGEUR BL 4.0 x 10.0 mm
190 m...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197533546·Zlider SPURLING RONGEUR BL 4.0 x 10.0 mm
130 m...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197533553·Zlider CUSHING RONGEUR BL 2.0 x 10.0 mm
180 mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197533577·Zlider LOVE GRÜNWALD RONGEUR BL 3.0 x 10
.0 mm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197533522·Zlider LOVE GRÜNWALD RONGEUR BL 3.0 x 10
.0 mm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197533508·Zlider CUSHING RONGEUR BL 2.0 x 10.0 mm
130 mm...
Diamondback 360 Peripheral Orbital Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Mural Perinatal Surveillance
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Showerbed
FDA UDI
Ropox A/S·05707581000461·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
NAVILYST MEDICAL
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL·Product code LJS·December 1, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 12, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 19, 2013
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013