10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESTORATION MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRULIFE, INC.
FDA registration
TRULIFE, INC.·13 products·🇺🇸 United States
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAQUET SAS
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·March 20, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 15, 2011
5.5MM TI CANCELLOUS LOCKING SCREW 26MM THRD LENGTH
FDA Adverse Event
Injury
·SYNTHESBRANDYWINE·Product code HWC·March 27, 2008
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code ITX·September 6, 2015
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020