23 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEUROSCOUT STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Bur PM2-70 80K steel Ø0.6mm sterile
FDA UDI
Bien-Air Surgery SA·J00711003510011·
Bur PM2-70 80K Steel Ø0.6 St
FDA UDI
Bien-Air Surgery SA·17630055503173·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK
IN-OVATION® Czr
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807H100351001·IN-OVATION® CZR Base Rx .018 LR5 -22T -1A 4D
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5
IN-OVATION® Czr
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807H100351101·IN-OVATION® CZR Base Rx .018 LR5 -22T -1A 4D HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
OCTRODE LEAD KIT, 90CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·April 17, 2025
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 7, 2022
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2021
ENDURANT ILIAC
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 8, 2013
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·September 18, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 13, 2011
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 30, 2025