10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 13, 2025
MODIFICATION TO CLEARFIL PHOTO BOND
FDA 510(k)
FDA Class 2
·Dental
STRATO X
FDA 510(k)
FDA Class 2
·Dental
SOL-MILLENNIUM
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·March 14, 2018
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 21, 2015
LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·May 3, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014
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