14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
XBit Series Digital Color Doppler Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
3D
FDA UDI
Rmo, Inc.·00885797100177·3D MULTIACTION APPLI ASST OF 6
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055698·METZENBAUM SCISSORS STRAIGHT BLADES POWER CUT B...
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
FDA 510(k)
FDA Class 2
·Neurology
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 27, 2024
DREAMSTATION 2 ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 3, 2025
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 8, 2024
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·July 30, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·July 1, 2013
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 27, 2018
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021