34 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
FDA 510(k)
FDA Class 2
·Neurology
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112167·HALO, 1203-5 VEST MEDIUM, COOLMAX LINER, 1211-1...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252254027·2.0MP LEFORT I PLATE,2MM ADVANCEMENT,L
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112020·Tap, 4.75 mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112020·Tap, 4.75mm
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
SURGICAL TISSUE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSI BIPOLAR SHEATH
FDA 510(k)
FDA Class 2
·Orthopedic
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 5, 2015
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code GEX·July 11, 2019
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 15, 2011
ENT EMG/LASER P/N UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·July 8, 2013
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·March 4, 2014