11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LATITUDE EV™
FDA UDI
TORNIER, INC.·00846832074815·Humeral Stem - Coated
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307211·Diamond, flame, medium grit
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742121901·DRACO MetaFuse Midfoot/Lisfranc Plate, Ti - (L)...
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
YALE NH TT VISION SYS GBS
FDA Adverse Event
Other
·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 2, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 22, 2011
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·August 22, 2014
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