11 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193022837·B-P HIP ACETABULAR BEARING - 32 MM I.D. X 60 MM...
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
FDA 510(k)
FDA Class 2
·Physical Medicine
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SMARTSITE GRAVITY SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·February 27, 2013
UKNOWN ZIMMER INTERNAL FIXATION DEVICE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KTT·February 15, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·March 31, 2008
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·June 11, 2014
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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