14 results
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27ms
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Sources: EU EUDAMED, US FDA
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033048·Baltic Denture System BDLoad Mn7 PLSEbim6DFm D2...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ALL TERRAIN WHEELCHAIR (ATW)
FDA 510(k)
FDA Class 1
·Physical Medicine
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 1, 2013
RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LIT·March 29, 2011
PUMP MMT-722WWS PRDGM INSULIN SK EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·April 22, 2008
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013