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

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Nexy

FDA 510(k)
FDA Class 2 ·Ophthalmic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI

Maestro™ Total Wrist

FDA UDI
Biomet Orthopedics, LLC·00887868239618·

MAESTRO TOTAL WRIST

FDA UDI
Biomet Orthopedics, LLC·00880304479487·

BYTE DAY ALIGNERS

FDA Adverse Event
Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOUND SURGICAL VASER 2.1 LIPO SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

URETERO-RENO VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FGB·December 30, 2025

EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·February 2, 2026

EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·November 5, 2025

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·July 27, 2011

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 17, 2014

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

FDA Enforcement
Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020