55 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450193372·
STATIC CRANIOPLASTY ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
ASCENSION MODULAR TOTAL SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
HF-RESECTION ELECTRODE, FOR TURIS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·February 9, 2023
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
5MM SINGLE USE ABS FIX DEVICE 10 TACKS
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·June 3, 2011
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
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
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 28, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·December 28, 2022
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
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·April 27, 2023