11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIMPLICITY
FDA 510(k)
FDA Class 2
·Dental
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160906·Channels Flex 31mm 15.04
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093615·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR2 14T/...
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062598·Mini Uni-Twin(TM) Bracket APC(TM) II UR2 14T/9A...
BIO-LOGIC CEEGRAPH NETLINK
FDA 510(k)
FDA Class 2
·Neurology
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
FDA 510(k)
FDA Class 2
·Cardiovascular
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
FDA Adverse Event
APPLIED MEDICAL·Product code GDO·March 20, 2013
ALLURA XPER FD10
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·February 10, 2011
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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