13 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
FDA 510(k)
FDA Class 2
·General Hospital
ACCU-CHEK ACTIVE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 26, 2016
REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HTD·June 1, 2016
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
ENCORE MODULAR HIP SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWB·June 16, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015