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

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SpeediCath Compact Set

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PATHWAY IVB/VBR

FDA 510(k)
FDA Class 2 ·Orthopedic

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FDX·February 22, 2021

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

DAMON COPPER NITI WIRE

FDA Adverse Event
Malfunction ·ORMCO CORPORATION·Product code DZC·October 10, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

AUTOCAT 2

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DSP·July 25, 2011

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

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

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

FUSION CYTOLOGY BRUSH

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code FDX·January 6, 2022

FUSION CYTOLOGY BRUSH

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FDX·October 25, 2021

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code FDX·May 4, 2022

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code FDX·November 14, 2022

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·August 27, 2024

FUSION CYTOLOGY BRUSH

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·July 31, 2024