9 results
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26ms
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Sources: EU EUDAMED, US FDA
DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)
FDA 510(k)
FDA Class 2
·Anesthesiology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large
NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHROCARE FLOW CONTROL UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·April 22, 2013
EXPRESS 4
FDA Adverse Event
Malfunction
·IRIS INTERNATIONAL·Product code JQC·August 12, 2014
ARCHITECT TOTAL B-HCG REAGENT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code DHA·April 28, 2011
Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
FDA Recall
Terminated
·Stryker Howmedica Osteonics·Product code LXH·February 10, 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