13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Neodent Instrument Kits
FDA 510(k)
FDA Class 2
·General Hospital
ClearFit
FDA UDI
LONGEVITI NEURO SOLUTIONS LLC·00855113008036·Extra Large Static Cranial Implant (Primary and...
LIPCOLLECTOR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PROGRESSA BED SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FNL·July 21, 2025
BD INTIMA-II
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·June 18, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 16, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022
Ingenia 3.0T-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: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021