21 results · 22ms · Sources: EU EUDAMED, US FDA

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KY Grosz Liquid

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OsteoMed

FDA UDI
OSTEOMED LLC·00845694009898·3.0mm x 32mm Cannulated Lag Screw

SAIPH

FDA UDI
MATORTHO LTD·05055455506145·SAIPH Femur Cemented Green Right Size 8

OsteoMed

FDA UDI
OSTEOMED LLC·00845694071260·Cannulated 3.0 x 32mm Lag Screw Sterile Qty 5

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ

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

ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

FDA Adverse Event
Malfunction ·STAAR SURGICAL CO.·Product code HQL·April 28, 2005

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

1030489-2019-01511

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014

FUSION PRE-LOADED OMNI-TOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·July 22, 2011

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

1030489-2019-01423

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·September 8, 2021

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 22, 2022

HANDLE ACETABULAR PRESS

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

ACETABULAR PRESSURIZER SMALL

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025