14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SPINEMED S200B/S200C
FDA 510(k)
FDA Class 2
·Physical Medicine
SPINEMED TABLE - FDA 510(K) K051013
FDA Adverse Event
Other
·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58210510130·RETRACTOR, ALL TYPES
TEKNO®
FDA UDI
Tekno-Medical Optik-Chirurgie GmbH·04044684023586·HALSEY NEEDLE HOLDER 13CM TC SMOOTH
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193103280·HA PEEK EVOS Curved, , 13mmx9mmx 30mm , FLAT 0 ...
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
FDA 510(k)
FDA Class 2
·Neurology
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
FDA 510(k)
FDA Class 1
·General Hospital
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·April 10, 2013
SUPERA BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·IDEV TECHNOLOGIES, INC.·Product code FGE·April 4, 2011
PHOTON MICRO VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
MANUAL CONTROLLED INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·April 15, 2015
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
FDA Enforcement
Class II
·Terminated·Cadence Science, Inc.·November 20, 2019
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 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