18 results · 20ms · Sources: EU EUDAMED, US FDA

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ORTHODONTIC CERAMIC BRACKETS 1.1

FDA 510(k)
FDA Class 2 ·Dental

AccuDiag™ Insulin ELISA

FDA UDI
Diagnostic Automation, Inc.·00850049545723·AccuDiag™ Insulin ELISA A collection of reagent...

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193024466·B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 150 MM

MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANC

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·July 5, 2019

ARSTASIS ACCESS SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
CONSMA·Product code ITJ·June 10, 2013

TALENT STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 6, 2011

ECHELON 45 ENDOPATH STAPLER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 5, 2008

MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·December 16, 2022

MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·April 17, 2019

MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·September 3, 2019

MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·March 29, 2018

MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·September 2, 2019

MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·September 20, 2018

MECTALIF ANTERIOR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·May 6, 2025

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018