8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
FDA 510(k)
FDA Class 2
·Microbiology
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
FDA 510(k)
FDA Class 1
·Dental
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Anesthesiology
TOTAL ASR FEM IMP SIZE 57
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·May 3, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 8, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·June 24, 2015
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