14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030157·VENERE 70, SIZE XXL, GLACE, GRADUATED COMPRESSI...
Schubert Biopsy Forceps
FDA UDI
MEDGYN PRODUCTS, INC.·M803030157·Schubert Biopsy Forceps 10" (254mm) Curved
0.6/1.2P366D-150
FDA UDI
SHIMADZU CORPORATION·04540217062287·
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TEMPORARY CROWN AND BRIDGE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 2, 2013
RUSCH GREEN RUSCHLITE MILLER 2 BLADE, DISP.
FDA Adverse Event
Malfunction
·TELEFLEX·Product code GCI·July 31, 2014
TOTAL HIP SYSTEM ACETABULAR LINER STANDARD
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·April 16, 2008
3.0 RIO® ROBOTIC ARM - MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·July 16, 2019
Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
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