13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIDA COMPACT II SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496052159·VENERE 70 OPEN TOE, SIZE XXL, MIELE, GRADUATED ...
RAPID DRUG SCREEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SNORE SAT RECORDER, MODEL SS41
FDA 510(k)
FDA Class 2
·Anesthesiology
ALL-IN-ONE TPN SOLUTION BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code KPE·August 10, 1994
DEKA SMARTXIDE WITH DOT SCANNER
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 14, 2023
MITEK VAPR P90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·April 11, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 12, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 20, 2008
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·August 1, 2023
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DXT·August 30, 2024
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