10 results
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18ms
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Sources: EU EUDAMED, US FDA
SUPERARM 2000 LIFT
FDA 510(k)
FDA Class 2
·Physical Medicine
TRU RP Healing Abutment 3.0mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549107634·Healing Abutments are intended for placement on...
Pedo OnBrace Crown LR2 (5/pk)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199013810·
IBEX SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CIDEX OPA SOLUTION
FDA 510(k)
FDA Class 2
·General Hospital
STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2020
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 8, 2013
SCD EXPRESS COMPRESSION SYSTEM
FDA Adverse Event
Death
·COVIDIEN·Product code JOW·November 3, 2010
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