15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Balloon Catheter B5-2C
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Stainless Steel Goldtone Archwire
FDA UDI
Ortho Arch Company Inc·D90925011814·.019 x .025 Stainless Steel Arches Right form G...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539845·Peapod Rongeur
2.5 x ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197162630·Micro Spatula Dissector
medium...
EBI TROCHANTERIC NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Diode Laser Therapy Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069896213·WIDEX EVOKE EBB3D (Tech Black ) 100, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069896473·WIDEX EVOKE E-FS (Tech Black ) 100, Telecoil, R...
Widex
FDA UDI
Widex A/S·05706069895056·WIDEX EVOKE ERB0 (Tech Black ) 100, RC coil, RI...
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
LEGEND DISSECTING TOOL
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBE·September 15, 2011
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·July 23, 2013
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024
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