13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
IFS BONE FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
Bone Screws
FDA UDI
ORTHOPEDIATRICS CORP.·00841132144206·TISSUE PROTECTOR
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA UDI
MEDULOC, LLC·00810184540298·Cannulated Drill (3.5)
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
FDA 510(k)
FDA Class 2
·Microbiology
DIMENSION DRUG CALIBRATOR, MODEL DC22B
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 8, 2013
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·April 27, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 2, 2008
BIOLOX HEAD HIP IMPLANT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 25, 2019
UNKNOWN BIOLOX HEAD
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 13, 2018
CERASUL, HEAD, M/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·November 4, 2019
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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