11 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STOCKERT CENTRIFUGAL PUMP CONSOLE
FDA 510(k)
FDA Class 2
·Cardiovascular
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160913·Channels Flex 31mm 15.06
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062604·Mini Uni-Twin(TM) Bracket APC(TM) II UL2 14T/9A...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093622·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL2 14T/...
MULITPLE MALE LATX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GE LOGIQ 700
FDA 510(k)
FDA Class 2
·Radiology
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
FDA Adverse Event
APPLIED MEDICAL·Product code GDO·March 20, 2013
CESAR/C-STANDFLOOR-OMCP-VISUB-CCD(V5000)
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·February 10, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008
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