14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
Opti-Cryl Pour Acrylic Original X 22 lb
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·00770112663119·Opti-Cryl Pour Acrylic Original X 22 lb
PH - Cramer B4 Trainer Kit - 111100 - CB977
FDA UDI
Certified Safety Manufacturing, Inc.·00766588226057·PH - Cramer B4 Trainer Kit - 111100 - CB977
REPROCESSED ATHROSCOPICS BURS
FDA 510(k)
FDA Class 2
·Orthopedic
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 27, 2013
BARDPORT
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEM·Product code LJT·March 4, 2011
JUVEDERM (VOLUME/CONCENTRATION UNK)
FDA Adverse Event
Injury
·CORNEAL·Product code LMH·April 1, 2008
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012
Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 '' Needle Catalog Number: 4254
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMJ·September 9, 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