17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071280·STRIPE GAME HORIZON, SIZE L, NERO, GRADUATED CO...
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
FDA 510(k)
FDA Class 1
·General Hospital
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRA DRIVE 6MM PLUG PULLER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·April 22, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·September 2, 2014
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 7, 2008
ORTHOPAEDIC SALVAGE SYSTEM CEMENTED INTRAMEDULLARY STEM 14MM X 150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 31, 2025
ORTHOPAEDIC SALVAGE SYSTEM POLY TIBIAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 31, 2025
ORTHOPAEDIC SALVAGE SYSTEM NON-MODULAR PROXIMAL TIBIAL COMPONENT 5CM 13X150
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 31, 2025
ORTHOPAEDIC SALVAGE SYSTEM 3CM RESURFACING FEMORAL COMPONENT RIGHT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 31, 2025
ORTHOPAEDIC SALVAGE SYSTEM POLY LOCK PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 31, 2025
ORTHOPAEDIC SALVAGE SYSTEM POLY TIBIAL BEARING 22MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 31, 2025
ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·January 31, 2025
ORTHOPAEDIC SALVAGE SYSTEM AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 31, 2025
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