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

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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