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

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APTUS K-WIRE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DELTA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252598237·S-DRILLING TAP, HEX, FOR 5/6mm SCREW

SPI ONETIME DENTAL IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

JAS URIC ACID LIQUID REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

JTS UNIT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·September 11, 2018

JTS COIL

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·February 13, 2020

FREESTYLE FREEDOM

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·October 17, 2016

RAD-8

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·July 15, 2015

FREESTYLE FREEDOM LITE

FDA Adverse Event
Injury ·Product code NBW·July 2, 2014

JTS DRIVE UNIT SET

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 6, 2023

FREESTYLE FREEDOM

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 27, 2017

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 3, 2013

JUVEDERM VOLUMA XC 27G 2 X 1ML

FDA Adverse Event
Injury ·ALLERGAN·Product code LMH·August 21, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 18, 2011

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

JTS DRIVE UNIT SET

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 15, 2022

PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

JTS DRIVE UNIT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 21, 2019

JTS DRIVE UNIT SET

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·May 27, 2022

JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·July 24, 2014