11 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Vericore Gradient Temporary Disc
FDA 510(k)
FDA Class 2
·Dental
Low Profile Acetabular Reamer 43
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057466·
ICY CATHETER, MODEL IC-3893A
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRAFIX TIBIAL SHEATH
FDA 510(k)
FDA Class 2
·Orthopedic
PHILIPS CPAP DEVICE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·April 18, 2024
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 28, 2011
SERVO-I
FDA Adverse Event
MAQUET, INC.·Product code CBK·August 15, 2008
ASAHI CONQUEST PRO 9-40
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024