30 results · 27ms · Sources: EU EUDAMED, US FDA

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RX-1 Rhythm Express Remote Cardiac Monitoring System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Vector Abducted Shoulder Immobilizer

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357837045·

Vanguard® Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304437098·

Vanguard Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304480001·

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575187942·Standard UHMWPE Insert - neutral with offset

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575187959·Standard UHMWPE Insert - neutral with offset

REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP

FDA 510(k)
FDA Class 2 ·Dental

NUTRAC PELVATOR, MODEL PEL 200

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ARCHITECT HAVAB-IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·May 8, 2026

INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·October 31, 2025

ARCHITECT HAVAB-IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·April 3, 2026

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 19, 2014

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

M2A 38MM MODULAR HEAD STD NK

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2013

PINNACLE MTL INS NEUT36IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 6, 2013

ARTICULEZE M HEAD 36MM +8.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 6, 2013

INSYTE

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·September 17, 2025

INSYTE

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·September 17, 2025

INSYTE

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·September 17, 2025

ALINITY I HAVAB IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·November 26, 2025