15 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
APC™ Flash-Free Victory Series™ Low Profile
FDA UDI
3M UNITEK CORPORATION·00652221232281·Victory Series(TM) Low Profile Bracket APC(TM) ...
APC™ II Victory Series™ Low Profile
FDA UDI
3M UNITEK CORPORATION·00652221063670·Victory Series(TM) Low Profile Bracket APC(TM) ...
APC™ PLUS Victory Series™ Low Profile
FDA UDI
3M UNITEK CORPORATION·00652221094704·Victory Series(TM) Low Profile Bracket APC(TM) ...
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C26430241060·Titanium ALIF Spacer, 30 x 24 x 10mm, 6 deg
MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 24, 2018
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 29, 2019
ENDO ANCHOR SYSTEM - HELI-FX AAA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code OTD·September 17, 2024
UNKNOWN NEUROSTIMULATION DEVICE
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·March 27, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 18, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code NDH·November 22, 2004
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012