25 results · 23ms · Sources: EU EUDAMED, US FDA

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SYNTHES PROXIMAL HUMERAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·H65810027291·K-FILES 21MM #90

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·10304040093952·Maxima K-Files 21mm

Diamond Orthopedic, LLC

FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2002729·3.0mm, Cannulated Screw, Self Drilling, Long T...

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF20027290·3.0mm Cannulated Screw, Self-Drilling, Long Thr...

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·February 6, 2026

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·February 6, 2026

ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL

FDA 510(k)
FDA Class 2 ·Cardiovascular

FOCUS

FDA 510(k)
FDA Class 2 ·Dental

QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 11, 2025

MINIMED QUICK-SET

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·October 22, 2024

MINMED QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·August 14, 2024

MINIMED QUICK-SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 18, 2025

UNKNOWN NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·March 13, 2013

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011

POLYFLUX S CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code KDI·February 27, 2008

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025

TECNIS SIMPLICITY

FDA Adverse Event
Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·August 15, 2025

TECNIS SIMPLICITY

FDA Adverse Event
Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 12, 2025

TECNIS SIMPLICITY

FDA Adverse Event
Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 12, 2025