29 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PENTAX Medical Video Bronchoscope EB11-J10
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
B.BRAUN
FDA UDI
B.Braun Avitum AG·04046963711160·DIALYSING LINE FUTURA (US)
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828128018·GEN4 DIGITAL
PROLITE VL PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BODY ANALYSIS SCALE, MODEL BG 17
FDA 510(k)
FDA Class 2
·Cardiovascular
VIDAS ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·January 21, 2021
VIDAS ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·January 21, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
SONICATOR PLUS 992
FDA Adverse Event
Injury
·METTLER ELECTRONICS CORP.·Product code IPF·October 23, 2008
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·August 12, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 8, 2013
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 11, 2023
NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·August 5, 2025
130° RADIOLUCENT TARGETING ARM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·October 17, 2025
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·November 17, 2020
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·January 21, 2021
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
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020