12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIPAP AUTOSV
FDA 510(k)
FDA Class 2
·Anesthesiology
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 2022
CONMED
FDA UDI
Conmed Corporation·10845854001646·WIRE PASS DRILL, SHORT , 1.5 X 19 MM
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450209998·
CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
PREMILENE 0 (3.5) 75CM DS30 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·May 12, 2016
EVOLUT FX PLUS VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·October 7, 2025
MX-PRO AMBULANCE COT OBS 10/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·April 19, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024