48 results · 27ms · Sources: EU EUDAMED, US FDA

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LightLas Pattern Scanning System - TruScan Pro

FDA 510(k)
FDA Class 2 ·Ophthalmic

Pre-Finisher

FDA UDI
TP ORTHODONTICS INC·00192029042120·4 Bicuspid Extraction

MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ASCENSION MODULAR TOTAL SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 12, 2023

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020

INSPIRE 8F M

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·July 29, 2011

DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR

FDA Adverse Event
Malfunction ·Product code GEH·June 21, 2013

INSPIRE 8F M

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

INSPIRE OXYGENATOR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 11, 2020

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·December 23, 2020

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·July 24, 2025