29 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
FDA 510(k)
FDA Class 2
·Radiology
M2A MODULAR HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304209244·
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
G-PROX EZ ENDOSCOPIC GRASPER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZOLL IVTM QUATTRO CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·September 18, 2021
I-STAT CG8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023
M2A-T M/H RAD 2HL SHL 41/56MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 23, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 11, 2013
SMART MONITOR 2
FDA Adverse Event
Other
·PHILIPS RESPIRONICS, INC.·Product code FLS·June 16, 2011
CONTOUR TEST STRIPS (10)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC.·Product code NBW·September 9, 2008
MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RIGHT-MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·August 18, 2017
M2A-T UNIV 2-HOLE SHL SZ 41/54
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·July 20, 2019
M2A-T UNIV 2-HOLE SHL SZ 41/54
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·March 26, 2019
TAPERLOC POR FMRL 10X140
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MEH·March 26, 2019
M2A TPR HI CARBON 41/32MM LNR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·March 26, 2019
INDIGO SYSTEM ASPIRATION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code DXE·August 11, 2020
M2A-T UNIV 2-HOLE SHL SZ 41/54
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 31, 2021
M2A TPR HI CARBON 41/32MM LNR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·March 31, 2021
M2A-T M/H RAD 2HL SHL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 25, 2017
M2A TPR HI CARBON 41/32MM LNR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·February 23, 2018