13 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large
RABEA 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844000519·The basic shape of the NUBIC and RABEA devices ...
RABEA 5°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844000663·The basic shape of the NUBIC and RABEA devices ...
BD SYRINGE 20ML LL SYRINGE ONLY MX BUN
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·November 12, 2021
POWDERED VINAL EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
KWIKKMODEL
FDA 510(k)
FDA Class 2
·Dental
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 15, 2022
CARTRIDGE
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·April 22, 2013
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·April 13, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 7, 2008
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