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

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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