21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S2 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
FDA 510(k)
FDA Class 2
·Cardiovascular
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
FDA 510(k)
FDA Class 2
·Dental
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 2, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·June 13, 2018
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·March 22, 2013
LIBERTE' CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·March 17, 2011
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code JJE·March 31, 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 31, 2018
INTELLAMAP ORION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 28, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 2, 2014
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017
ESPRIT¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code NXW·January 8, 2026
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014