11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SHERWOOD VENTILATORY MUSCLE TRAINER
FDA 510(k)
FDA Class 1
·Anesthesiology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515208575·New Orleans Lens Loop
STERILE SALINE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
LINEZOLID, 30UG, BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013
MODULAR MICROPLASTY CUP INSERTER 3/8" THREAD
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2010
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024