13 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXTENTRAC
FDA 510(k)
FDA Class 2
·Physical Medicine
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074338729·CAPSTONE BONE INSTRUMENT TRAY
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980021·DeltaForm HD lower posteriors, XL, A3 -MADE IN ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690110552·Threaded Steinman Pin
Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs
FDA UDI
Delfi Medical Innovations Inc·M995979800211·Delfi Matching Limb Protection Sleeves (MLPS) h...
Proton Positioing and Immobilization Devices
FDA 510(k)
FDA Class 2
·Radiology
URINE SCREENING KITS
FDA 510(k)
FDA Class 1
·Microbiology
ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 25, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013
UTERINE ARTERY EMBOLIZATION
FDA Adverse Event
Injury
·Product code NAJ·February 1, 2011
BD POWERME
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code PND·December 15, 2023
ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·November 28, 2012