29 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DuraGraft Vascular Conduit Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD BBL™ Streptocard™ Acid Extraction Reagent
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902409250·BD BBL™ Streptocard™ Acid Extraction Reagents 1...
Burr
FDA UDI
KATENA PRODUCTS, INC.·00841668113158·DIAMOND BURR 5.0MM DIAMETER BALL
Gibralt
FDA UDI
Choice Spine, LP·10885862145086·
ACUMED SUTURE ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NORMAL AND HYPERGAMMA CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
OMNIDIAGNOST - CONVENTIONAL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·August 17, 2011
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·July 17, 2013
SINGLE USE GUIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 23, 2025
MERIT MEDICAL DURA MAX 28 CM TUNNELED HEMODIALYSIS CATHETER
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code MSD·February 18, 2025
IMP,TSV,3.7,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 16, 2021
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·April 2, 2025
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020