11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Scio Four, Oxi
FDA UDI
Drägerwerk AG & Co. KGaA·04048675429326·
SubRF Std. 64 Tip,Fuse (100 Pulse), 10-Pk, SubRF
FDA UDI
Candela Corporation·00817495024301·SubRF Std. 64 Tip,Fuse (100 Pulse), 10-Pk, SubRF
Rongeur
FDA UDI
KATENA PRODUCTS, INC.·00841668108505·KERRISON RONGEUR SIZE 3
ARDS DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
HIVOX OTC Electrical Stimulator
FDA 510(k)
FDA Class 2
·Neurology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 17, 2014
CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 16, 2010
ENSEAL SUPER JAW
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 13, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023