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

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ETEST LINEZOLID

FDA 510(k)
FDA Class 2 ·Microbiology

USB-Dongle red

FDA UDI
ZIRKONZAHN SRL·D800KT002139·USB-Dongle red for Zirkonzahn Scanner

artVeneer life

FDA UDI
Merz Dental GmbH·D7092002139·artVeneer life lower posteriors, XS, D2

CURE OPEL-L (S)

FDA UDI
MEDITECH SPINE, LLC·B167900021390·

CURE OPEL-L (S)

FDA UDI
MEDITECH SPINE, LLC·B167S1900021390·

PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

FDA 510(k)
FDA Class 2 ·Cardiovascular

MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED

FDA 510(k)
FDA Class 1 ·General Hospital

ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS·Product code LWS·January 16, 1997

OT ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·September 14, 2011

2520274-2013-10215

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code MNI·February 11, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·February 4, 2011

PUMP MMT-515NAP PRDGM INS V2.1 PL EN

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·February 25, 2008

Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator

FDA Enforcement
Class I ·Ongoing·Hamilton Medical, Inc.·September 27, 2023

Colonoscope, Model Number CF-H180AL.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024