11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CADWELL EASYNET OXIMETER MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
WMT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXICAST PRIME
FDA 510(k)
FDA Class 2
·Dental
G7 OSSEOTI 4 HOLE SHELL 60MM G
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code OQI·March 25, 2020
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·April 16, 2013
PKS SEAL OPEN FORCEPS WITH ATTACHED CORD
FDA Adverse Event
Malfunction
·GYRUS MEDICAL, INC·Product code GEI·June 2, 2008
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·April 18, 2011
G7 STR INSRTR THREADED SHAFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2020
Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015