15 results · 19ms · Sources: EU EUDAMED, US FDA

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ADVANCED HIP ASSESSMENT SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120119171·Steel, round, finishing bur

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033335765·

POWER TILT AND RECLINE SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

PARODI CATHETER FOR ANGIOGRAPHY (PARCA)

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 14, 2025

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 17, 2021

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 4, 2024

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 14, 2018

DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWE·March 19, 2013

COVAC 70 WAND, 3.0 MM WITH INTEGRATED CABLE

FDA Adverse Event
Other ·ARTHROCARE CORP·Product code GEI·February 25, 2011

SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·March 10, 2008

5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML

FDA Adverse Event
Death ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FOZ·July 12, 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

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025