98 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
FDA 510(k)
FDA Class 2
·Anesthesiology
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
FDA 510(k)
FDA Class 2
·Orthopedic
BALL HEADS: COCR BALL HEAD 12/14 28 SIZE XL +7
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 24, 2020
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·February 5, 2021
VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 26, 2016
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 15, 2025
MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (USA)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 20, 2023
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
STEM: AMISTEM H HA COATED LAT STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 21, 2019
QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 19, 2016
VERSAFITCUP DM HIGHCROSS ACETABULAR LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·September 6, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·July 24, 2008
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·December 4, 2012
CUP: VERSAFITCUP ACETABULAR SHELL Ø 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·November 18, 2019
QUADRA-S 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·August 25, 2021
VERSAFITCUP ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·June 9, 2016
VERSAFITCUP ACETABULAR SHELL 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·February 16, 2021