29 results · 25ms · Sources: EU EUDAMED, 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