9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEARFIL MAJESTY POSTERIOR PLT
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450249604·
TRS-2000 POWER TILT/POWER RECLINE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
STELKAST PROVEN KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 17, 2026
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 3, 2013
SYS 6 RECIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·September 16, 2014
SECURE ACUTE CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 3, 2011
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