20 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Unscented Menstrual Tampon
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017880·K-Wire, Double Ended, Trocar Point, Diameter Si...
Sierra Wave
FDA UDI
CADWELL INDUSTRIES, INC.·00840067102039·Sierra Wave Footswitch
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804304·Cottle Thumb Hook, 8mm Double Prong w/Adjustabl...
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022402726·Guide Rod, Tibial Cone D18/L120
NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·November 30, 2018
MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
FDA 510(k)
FDA Class 2
·Radiology
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
FDA 510(k)
FDA Unclassified
·Unknown
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 8, 2016
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 19, 2023
VICTORY
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code DXY·October 7, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
OPTETRAK
FDA Adverse Event
Other
·EXACTECH, INC.·Product code JWH·June 18, 2013
BD 30G NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·October 21, 2021
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·May 16, 2019
EXPRESSEW III AC+ GUN
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code LXH·August 16, 2019
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·December 10, 2019
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020