19 results
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24ms
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Sources: EU EUDAMED, US FDA
Devon 51
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741720300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674172030060·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694027083·2.0mm X 30mm Cannulated Headless Screw
External Fixation
FDA UDI
Life Spine, Inc.·00190837023072·Male Post, 3 Hole
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100813·FLIERINGA FIXATION RING 20MM
Mech Screw Fitting
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076467·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694068604·Cannulated 2.0 x 30mm Headless Screw Sterile Qty 5
IMPLANT CENTER
FDA 510(k)
FDA Class 2
·Dental
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Otrieva
FDA UDI
WILLIAM A. COOK AUSTRALIA PTY. LTD.·00827002565425·Otrieva, Tapered Ovum Aspiration Needle, Single...
HANDLE FOR 90° SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code DZI·September 24, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 22, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 1, 2021
2.0MM X 30MM CANNULATED HEADLESS SCREW
FDA Adverse Event
Injury
·OSTEOMED·Product code HWC·January 18, 2019
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020