15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
FDA 510(k)
FDA Class 2
·Orthopedic
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555235·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868240072·
ANDREWS PYNCHON SUCTION
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000520·ANDREWS PYNCHON SUCTION STAINLESS STEEL
ANDREWS PYNCHON SUCTION
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804360·ANDREWS PYNCHON SUCTION STAINLESS STEEL
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024
CLICKFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYSTEM 7 DUAL TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·October 17, 2014
ROTALINK? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MCX·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026