16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193022844·B-P HIP ACETABULAR BEARING - 32 MM I.D. X 62 MM...
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
FDA 510(k)
FDA Class 2
·Radiology
GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·February 27, 2013
UNKNOWN ZIMMER INTERNAL FIXATION DEVICE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KTT·February 15, 2011
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM·Product code DZE·March 31, 2008
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
OSS CEMENTED STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·December 13, 2017
OSS SEGMENTAL FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·December 13, 2017
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
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026