20 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMAGEN ENA [JO-I] KIT
FDA 510(k)
FDA Class 2
·Immunology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227484·House-Wullstein Cup Fcps, .6x1mm oval, ang down
Medical surgical mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ETEST LINEZOLID
FDA 510(k)
FDA Class 2
·Microbiology
SYRINGE S2 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 20, 2019
NEUROMONITOR BASIC KIT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·October 18, 2022
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 15, 2024
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 15, 2024
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 15, 2024
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 15, 2024
BD DISCARDIT II 20 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 21, 2019
SYRINGE S2 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 3, 2019
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 8, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 15, 2010
DENTEMP ONE STEP .077OZ, SKU 902139
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code EMA·October 4, 2023
DENTEMP ONE STEP .077OZ, SKU 902139
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code EMA·June 23, 2022
DENTEMP ONE STEP .077OZ, SKU 902139
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
DENTEMP ONE STEP .077OZ, SKU 902139
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
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