12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEAK NS033CF, PEAK NS017CF
FDA 510(k)
FDA Class 2
·Dental
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304677319·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083928·RYDER-VASCULAR TC Needle holder,smooth
14 cm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197453295·CCR Titanium Longitudinal Blade
24x65m...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083935·RYDER-VASCULAR TC Needle holder,smooth
16 cm,...
MODIFICATION TO: SAVI APPLICATOR KIT
FDA 510(k)
FDA Class 2
·Radiology
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
FDA 510(k)
FDA Class 3
·Cardiovascular
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 27, 2011
8010042-2008-00108
FDA Adverse Event
Malfunction
·Product code CBK·July 21, 2008
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 27, 2014
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020