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

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MOBILEDIAGNOST WDR

FDA 510(k)
FDA Class 2 ·Radiology

Best Medical International

FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365102967·

C2 LATERAL. FEMORAL STEM # 2

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code LZO·September 5, 2019

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311117250·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321117250·

Rhythmlink®

FDA UDI
RHYTHMLINK INTERNATIONAL, LLC·00816312024715·50 Monopolar Needle Electrodes, EMG, 25mm x 27g

Chalgren

FDA UDI
CHALGREN ENTERPRISES·00816020020115·Monopolar Needle Electrode, EMG, 25mm x 27g

OLYMPUS SUCTION PUMP, MODEL KV-5

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

TRIGEN LOW PROFILE BONE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

CADD SOLIS VIP PUMPS

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022

W1-SS-111725

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Ze Fang Technology Co., Ltd.·1 device

OPLUM A+ PUMP DRIVER

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·May 7, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

MEDPOR IMPLANT

FDA Adverse Event
Injury ·STRYKER CRANIOMAXILLOFACIAL GEORGIA·Product code FWP·June 2, 2011

TRI-STAPLE 2.0

FDA Adverse Event
Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024

LIBRE 2 SENSOR FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024

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

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018