17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CHURCHILL MEDICAL SYSTEMS STOPCOCK
FDA 510(k)
FDA Class 2
·General Hospital
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009307·Zirlux 16+ White 89x17x25
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450241493·
Cuff with connector
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904003900·
NA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 7, 2012
RANGER II M6, MODEL IN-888WNL
FDA 510(k)
FDA Class 2
·Physical Medicine
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
XPS® BUR - STYLUS TRANSNASAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 13, 2013
NAC SP 09 NAVLOCK SEXTANT KIT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 1, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 31, 2015
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 31, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 31, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA·Product code KWP·March 31, 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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024