17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
HI-TORQUE VERSATURN
FDA UDI
ABBOTT VASCULAR INC.·08717648198458·HI-TORQUE VersaTurn F Guide Wire Uncoated Tip ....
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918180656·Back Table cover_60inx90in_Non-sterile_50EA/CS
Cosmolock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm
RANDOX HUMAN ASSSAYED DRUG CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
FDA 510(k)
FDA Class 2
·Orthopedic
SILASTIC MAMMARY PROSTHESIS
FDA Adverse Event
Injury
·DOW CORNING CORP.·Product code FTR·May 1, 1998
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·April 27, 2015
INTERJECT¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FCG·March 20, 2013
Y-TYPE TUR-BLADDER IRRIGATIONSET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code LJH·March 10, 2011
BLACKSTONE ICON SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·BLACKSTONE MEDICAL, INC.·Product code KWQ·March 12, 2008
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 4, 2015
TALENT AAA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 4, 2015
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 4, 2015
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018