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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HIGH FLOW INSUFFLANTION UNIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704624246·RUSCH Traditional Guedel Airway Length 80mm Tra...
SCOTT'S SELECT K-FILES 6/pk 21mm # 80
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811221801·ENDODONTIC K-FILES (6/pack) Length: 21mm, Size:...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 26, 2023
RHEAD RADIAL HEAD EXTENDED STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
DIRECT BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 8, 2020
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 24, 2020
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 21, 2013
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·August 15, 2008
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022