13 results · 28ms · Sources: EU EUDAMED, US FDA

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AMPHETAMINES II ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DELFIA NEONATAL IRT KIT, MODEL A005-110

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COALESCENT SURGICAL U-CLIP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

INTIMA-II 24GAX0.75IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·October 28, 2025

BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·November 25, 2025

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

FDA Adverse Event
Injury ·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

FDA Adverse Event
Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011

NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER INC·Product code NJL·May 1, 2013

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014

DXTEND MBLOC HUM EPI 1 D10 STD

FDA Adverse Event
Injury ·DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code HSD·May 12, 2011

UNKNOWN PFM-R DISTAL STEM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·March 13, 2018

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

Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018