27 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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