11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROGENIX
FDA 510(k)
FDA Class 2
·Dental
Sleepware
FDA UDI
Respironics, Inc.·00606959045262·Software, Sleepware G3 (Multi-Lingual)
Sleepware
FDA UDI
Respironics, Inc.·00606959004856·Sleepware G3 Software Package, Multi Lingual
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
FDA 510(k)
FDA Class 2
·Neurology
STELLAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 17, 2025
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 10, 2011
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 22, 2008
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 2, 2022
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