33 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PRECICE Intramedullary Limb Lengthening System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131318763·OPN 2, MRITE 312 2.4G NFM PB C068
COMFORT TOUCH INSUIN PEN NEEDLES
FDA Adverse Event
Malfunction
·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
ENDOCLEAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CANCELLOUSSCR SYNAPSE Ø4.5 L30 TAN
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code KWP·June 14, 2013
NAVILYST MEDICAL, BIOFLO
FDA Adverse Event
Injury
·NAVILYST MEDICAL·Product code LJT·September 30, 2014
ACCUFLEX (273 MICRON)
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP. (UROLOGY)·Product code GEX·September 8, 2008
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·April 3, 2025
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
(17-0346) ANK IMPL A14 D3.5 MM/L14 MM
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·February 16, 2021
(17-0346) ANK IMPL A14 D3.5 MM/L14 MM
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·February 16, 2021
(17-0346) ANK IMPL A14 D3.5 MM/L14 MM
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·March 20, 2021
(17-0346) ANK IMPL A14 D3.5 MM/L14 MM(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 3, 2021
(17-0346) ANK IMPL A14 D3.5 MM/L14 MM(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 9, 2021