14 results · 28ms · Sources: EU EUDAMED, US FDA

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SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER

FDA 510(k)
FDA Class 2 ·General Hospital

NexxZr™ T / D-100-30-NT-D200-SD

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113634·

MOBIUS ULTRASOUND IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML

FDA 510(k)
FDA Class 2 ·Microbiology

FASTTAKE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·March 27, 2002

FASTTAKE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·September 22, 2003

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 15, 2003

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013

TECNIS 1-PIECE

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code HQL·June 17, 2011

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 16, 2018

Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

FDA Enforcement
Class II ·Terminated·Amendia, Inc·December 28, 2016

Achieva 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023