22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEURO II-SE, MODELS OR-MB-DR AND OR-DR
FDA 510(k)
FDA Class 2
·Radiology
REMEL
FDA UDI
REMEL, INC.·00848838008405·OF Medium w/1% Dextrose (4ml) 100/PK
OsteoMed
FDA UDI
OSTEOMED LLC·00845694017749·MFx Tag, Angulated Locking Safety Screw, 16mm
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330600·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330631·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330624·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330617·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330563·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330570·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330587·3D Porous Titanium Cervical Interbody, 19x16mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330594·3D Porous Titanium Cervical Interbody, 19x16mm,...
32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 7, 2016
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013
MITEK FMS PUMP
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·June 16, 2008
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 5, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 25, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code NKB·October 8, 2010
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