14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TDM Plate and Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100790·FLIERINGA FIXATION RING 18MM
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
FDA 510(k)
FDA Class 2
·Orthopedic
MIRAGE MICRO
FDA 510(k)
FDA Class 2
·Anesthesiology
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
CLEARLINK CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
6000 CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 23, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 11, 2022
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·February 11, 2026
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021