11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RINGLOC + HYBRID ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
Sami the Seal
FDA UDI
VEGA TECHNOLOGIES INC.·06946159501019·1093235
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450445433·
PE.R.I. II KNEE FRACTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SYNCHRON CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 10, 2024
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 5, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 3, 2011
145-DEG PE 36MM HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·December 10, 2024
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