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