8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
FDA 510(k)
FDA Class 1
·General Hospital
3.5 MM LAPAROSCOPE (LG100, LG103)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COPC BAND
FDA 510(k)
FDA Class 2
·Neurology
11MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·April 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2011
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code MAF·July 25, 2008
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 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