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

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RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A

FDA 510(k)
FDA Class 2 ·Cardiovascular

NA

FDA UDI
MAKO SURGICAL CORP.·00848486002565·END EFFECTOR DOUBLE ANGLE COLLET

OLYMPUS INSTRUMENT TRAY

FDA 510(k)
FDA Class 2 ·General Hospital

FIRST FILL R.C.S.

FDA 510(k)
FDA Class 2 ·Dental

VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

MECTALIF TRANSFORAMINAL CAGE 12X30X9 L5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code MAX·June 26, 2015

PELVICOL 4 X 12 CM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·April 16, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·August 12, 2008

VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 25, 2023

VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·June 1, 2023

COREVALVE TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 27, 2019

VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 9, 2023

VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·April 5, 2023

ALINITY C MAGNESIUM

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JGJ·February 16, 2026

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025