12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TAD AND TAD II TAPERED GUIDE WIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
Harvard PremiumSil Heavy Fast
FDA UDI
Harvard Dental International GmbH·EHAR70837321·Vinylpolysiloxane impression material, super hy...
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
GELZONE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AXIOM ARISTOS VX PLUS
FDA Adverse Event
Injury
·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021
AS COLUMBUS REV F FEMUR ZEMENTIERT F5L
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·November 6, 2019
AFFINITY DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 10, 2014
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 29, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·May 10, 2011
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LZO·April 24, 2026
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 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