28 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
FDA 510(k)
FDA Class 2
·Anesthesiology
IMPACT MODULAR
FDA UDI
Biomet Orthopedics, LLC·00880304304369·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390850261·
Rod Width Caliper
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068806·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089452774·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390867344·
MEDRANGE ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089452842·
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·November 13, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2021
LIFEVEST WCD 400 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 3, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 23, 2014
HYPERGLIDE OCCLUSION BALLOON SYSTEM
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code MJN·June 2, 2011
BD PHASEAL¿ PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·February 15, 2023
S8 PREMIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 4, 2020
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·January 25, 2017
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·October 11, 2023
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025