24 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMV Scientific Schanz Screws
FDA 510(k)
FDA Class 2
·Orthopedic
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481123238·LOCATOR R-Tx Attachment System for SS Fixture, ...
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481124297·Locator F-Tx Abutment for Regular Platform SS I...
MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANC
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·July 5, 2019
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
FDA 510(k)
FDA Class 2
·Cardiovascular
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
FDA 510(k)
FDA Class 1
·General Hospital
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 10, 2013
OCTRODE 90-CM LENGTH PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 6, 2011
TARGET DEVICE 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 10, 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
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·November 13, 2019
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·August 13, 2017
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
FLEXITRUNK INFANT NASAL PRONGS
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·September 29, 2016
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·July 29, 2020