11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981125·anteriors; shade A4; mould IM2
Symmetry
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482033166·Symmetry® Forceps, Glassman, Ratcheting Handle ...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756036672·N/S Rubber Elastic Bandage
9811-25 - F-Socket Sensor
FDA UDI
Tekscan, Inc.·B9709811250·9811-25 - F-Socket Sensor
WRIST PULSE OXIMETER MD300W
FDA 510(k)
FDA Class 2
·Cardiovascular
LDH ISOENZYME REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·February 27, 2013
PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 8, 2011
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTW·August 5, 2014
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024