13 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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