13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tomcat Cervical Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
RHEAD
FDA UDI
Stryker GmbH·00886385023700·Radial Broach Assy; Size 3
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077408·Reverdin abdominal retractor
28 cm,...
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
FDA 510(k)
FDA Class 2
·General Hospital
VISENSIA, VISENSIA WITH ALERT
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE SFTYGLD 18X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·July 29, 2020
BD SAFETYGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·November 13, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 21, 2011
REGENEREX/RINGLOC+ MULTI 58MM SIZE 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 14, 2013
INNER SHAFT FOR EXTRACTION SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·August 1, 2018
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018