20 results · 32ms · Sources: EU EUDAMED, 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 SàRL·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