15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GAMMA STICK 125-1 TOBRAMYCIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ORTHOSOURCE
FDA UDI
ORTHOSOURCE·D9118100110·Anterior Fan Expander
TiWAVE C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07320K0100110·Handle, Universal Slim with Depth Stops
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100110·Tray Insert, Rod Connectors
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100110·Tray Insert 4, Cosmolock, Arcamed
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·December 5, 2003
TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Pulmonx Chartis Tablet Console
FDA 510(k)
FDA Class 2
·Anesthesiology
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 16, 2002
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 12, 2007
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·October 23, 2012
MICRUSFRAME18 8MM X 30CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 20, 2020
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024