17 results · 21ms · Sources: EU EUDAMED, 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