21 results · 24ms · Sources: EU EUDAMED, US FDA

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s-Clean Tapered II RBM Implant System

FDA 510(k)
FDA Class 2 ·Dental

Tungsten Carbide Burr

FDA UDI
ELLIQUENCE, LLC·00846338003920·

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193023964·B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 50 MM

VIDAS® MEASLES IGG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LJB·February 12, 2016

GE DATEX-OHMEDA AISYS

FDA 510(k)
FDA Class 2 ·Anesthesiology

LUMANOSITY CELEBRITY, MODEL 204

FDA 510(k)
FDA Class 2 ·Physical Medicine

FLEXITRUNK INFANT NASAL TUBING

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·July 26, 2016

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·March 8, 2018

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

HUDSON NEONATAL VENTILATOR CIRCUIT W/18 IN R

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code BZO·June 2, 2011

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

OHICHO3

FDA Adverse Event
Injury ·Product code LIT·July 19, 2019

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 14, 2020

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·September 30, 2020

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·May 28, 2020

OHICHO3

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·September 26, 2018

OHICHO3

FDA Adverse Event
Injury ·Product code LIT·September 17, 2019

Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

FDA Enforcement
Class I ·Terminated·Cook Inc.·March 2, 2016

SURESTEP

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code CGA·May 22, 1998