14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
FDA 510(k)
FDA Class 2
·Cardiovascular
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
Sklar®
FDA UDI
SKLAR CORPORATION·10649111203534·BERLINER PERC HAMMER 8"
SteriBest
FDA UDI
INTERNATIONAL SURGICAL PRODUCTS INC·00810147254453·ROLLER WELDED CAMERA BASKET 12.4" x 8" x 4.5"
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TECHNOS MP, MODEL AU6
FDA 510(k)
FDA Class 2
·Radiology
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·March 27, 2013
HUT EXT DR FINAL ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·March 22, 2011
PFC KEEL TIB TRAY CEM SZ3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, DEPUY-CORK·Product code JWH·June 18, 2008
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LZO·February 17, 2016
KINECTIV MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWA·May 26, 2016
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·January 6, 2025
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