18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
VPAP III ST-A
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033276·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
FDA 510(k)
FDA Class 2
·Cardiovascular
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
HOURGLASS
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·June 16, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 18, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021