75 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

WEGO-PTFE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ULCELOOCIN ORAL ULCER PATCH

FDA 510(k)
FDA Unclassified ·Unknown

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM

FDA 510(k)
FDA Class 2 ·Cardiovascular

COMFORT TOUCH INSUIN PEN NEEDLES

FDA Adverse Event
Malfunction ·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021

MINIMAX STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025

MINIMAX RIGHT ANATOMICAL BROACH SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 14, 2013

30G DENTAL NDL

FDA Adverse Event
Malfunction ·COVIDIEN·Product code DZM·June 22, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 14, 2014

MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019

CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019

CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021

POD PACKING COIL

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·November 8, 2017

POD PACKING COIL

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·October 23, 2017

Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025