9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BIOELAST 5-0 SUTURE, MODEL 500100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 11, 2021
MODIFICATION TO N PROTEIN STANDARD SL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·April 23, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2011
KAPPA 700 DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·July 10, 2008
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
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