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