38 results
·
26ms
·
Sources: EU EUDAMED, US FDA
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Osstell SmartPeg Type 48
FDA UDI
Osstell AB·09010522001578·ISQ Measurement Peg
SONTEC-COTTLE OSTEOTOMES
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047648·SONTEC-COTTLE OSTEOTOMES WITH CANVAS BAG
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450177792·
SONTEC COTTLE OSTEOTOMES SET
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047655·SONTEC COTTLE OSTEOTOMES SET WITH CANVAS BAG
DIGITAL ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2021
BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2021
PS TIBIAL INSERTS SZ 5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 28, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·May 17, 2011
BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 27, 2021
BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
FDA Adverse Event
Malfunction
·Product code FMF·September 27, 2021
BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 30, 2021
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024