18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
FDA 510(k)
FDA Class 2
·Anesthesiology
AGXO
FDA UDI
Oticon A/S·05707131286208·H160V2 TI, RITE 312 WL CBE AGXO
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120588·Guidewire 2.4x150mm Sgl Trocar
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199526·Modular Knee Straight Reamer - 24mm
Temporary Abutment
FDA UDI
BICON, LLC·00813110021038·5.0 x 4.5mm Temporary Abutment - 2.0mm Post
HS/HG PROSTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CELLSEARCH CIRCULATING TUMOR CELL KIT
FDA 510(k)
FDA Class 2
·Immunology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 25, 2023
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
STOPCOCK MANIFOLD GANGS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 19, 2016
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 6, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 10, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·September 3, 2008
MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DTE·February 10, 2021
ASAHI GLADIUS EX
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025
ASAHI GLADIUS EX
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026
BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 10, 2022