21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CystoFlex™F
FDA UDI
MAUNA KEA TECHNOLOGIES·00827002472747·
CystoFlex™F
FDA UDI
MAUNA KEA TECHNOLOGIES·03760187910123·
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642108514·Modular Spacer, 34 mm (W) x 30 mm (L) x 15 mm (...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450752319·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197025119·Collin Scalpel Handle No.8
135mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197025126·Collin Scalpel Handle No. 9
145mm,...
ENA EIA KIT RANGE
FDA 510(k)
FDA Class 2
·Immunology
EVOLVE EPS ORTHOLOC
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 17, 2021
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·March 27, 2009
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 13, 2013
PROMUS PREMIER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 23, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 19, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2013
POLYMETHYLMETHACRYLATE BONE CEMENT
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code NDN·August 16, 2016
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025