12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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T3 Platform software
FDA 510(k)
FDA Class 2
·Cardiovascular
Sierra Ascent
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100134·Sierra Ascent Base
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306822254·Dissector/ Probe, Double Ended ; 130mm, Pointed...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721131·Buck Ear Curette 6-1/2" (16.3cm), size 2, sharp...
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
FDA 510(k)
FDA Class 2
·Anesthesiology
INSTAFLO BOWEL CATHETER SYSTEM KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020
MIS CANNULATED POLYAXIAL SCREW
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NKB·October 21, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 19, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 26, 2013
PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
FDA Adverse Event
Malfunction
·WICKIMED·Product code GEI·June 7, 2022
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025