61 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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6440 Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
CAPSTONE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
FDA 510(k)
FDA Class 2
·Dental
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·November 29, 2019
LINER: MPACT FLAT PE HC LINER 32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 14, 2021
CAPSTONE VERTEBRAL BODY SPACER
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·July 3, 2017
CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 1, 2020
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code KWP·November 14, 2018
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 22, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 22, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
CAPSTONE CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code MAX·November 19, 2015
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·October 26, 2018
CAPSTONE VERTEBRAL BODY SPACER
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MAX·July 2, 2009
CAPSTONE SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·September 3, 2010
CAPSTONE® SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·April 17, 2014
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·October 18, 2017
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MAX·December 21, 2009
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 23, 2011