21 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033128886·
SUNTASTIC
FDA UDI
FGX INTERNATIONAL INC.·00070135415376·
SUNTASTIC
FDA UDI
FGX INTERNATIONAL INC.·00031568714306·
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467507829·24-Channel Customized Single-Use Antroduodenal ...
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467507836·24-Channel Customized Single-Use Colonic Catheter
FERTELL MALE FERTILITY TEST
FDA 510(k)
FDA Class 2
·Hematology
HepaFat-AI
FDA 510(k)
FDA Class 2
·Radiology
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026
PUMP MMT-522NAB PRDGM INS V2.2. BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 21, 2008
SYNERGY COMPACT PLUS
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 17, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013
SYRINGE 1ML 30G 8MM CENTRAL EURO
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·May 20, 2024
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·December 26, 2024
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 6, 2025
BELLATEK¿ HYBRID BAR 5 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·February 18, 2025
SYRINGE 1ML 30G 8MM CENTRAL EURO
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·January 15, 2025
BELLATEK HYBRID BAR 5 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·March 18, 2025
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 6, 2025