27 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BioCode Gastrointestinal Pathogen Panel (GPP)
FDA 510(k)
FDA Class 2
·Microbiology
X-CORE
FDA UDI
Nuvasive, Inc.·00887517426529·X-CORE 2 Ti Core, Ø18x28-41mm
Finn® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868251757·
FINN KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304268869·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694004879·150 x 300mm Mesh Plate
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100943·JAFFE LID RETRACTOR SMALL
8.0MHZ PENCIL PROBE 10'
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020861·
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SHEATHES STERILE ULTRASOUND GEL
FDA 510(k)
FDA Class 2
·Radiology
Distraction Paddle - 9mm
FDA UDI
CAPTIVA SPINE, INC.·00850065741642·Distraction Paddle - 9mm
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023
TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·October 17, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011
SROM*EXTENSN,TIB STEM,17X100MM
FDA Adverse Event
Malfunction
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 20, 2013
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 3, 2021