26 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Membrane Screws and Membrane Tacks
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257156186·TG 8MM 3# FOAM CONDYLAR BK/BK HOOK
EarQ
FDA UDI
Oticon A/S·05707131352408·G50 S, MINIRITE 312 2.4G C094 EARQ
C6 Sensor D
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C6D0·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450274392·
TX1 TISSUE REMOVAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O
FDA 510(k)
FDA Class 1
·General Hospital
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·October 16, 2008
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 27, 2012
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 13, 2018
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·June 4, 2021
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020