10 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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CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112163·3M™ Victory Series™ First Molar Bands, 902-374,...
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
FDA 510(k)
FDA Class 2
·Dental
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
FDA 510(k)
FDA Class 2
·Ophthalmic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 8, 2013
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 12, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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