42 results · 25ms · Sources: EU EUDAMED, US FDA

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DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ArgenZ HT+ 98x30 D4

FDA UDI
ARGEN CORPORATION, THE·D818122126·Dental porcelain/ceramic restoration kit

GENUINE FIRST AID CPR MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 28, 2022

T:SLIM X2, BASAL-IQ, MMOL/L

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 23, 2020

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2019

OT ULTRA2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·July 18, 2019

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

HEARTSTREAM FR2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014

ASR ACETABULAR CUPS 52

FDA Adverse Event
Injury ·DEPUY INTL LTD.·Product code KWA·June 3, 2011

MICRA

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code PNJ·February 9, 2017

Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·July 16, 2014

ONE TOUCH ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·April 9, 2010

ARROW RA CATH SET: 22 GA X 1-3/8"

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code DQX·August 2, 2021

ILS 21MM CURVED

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2018

ETS45 ENDO LINEAR CUTTER 45MM

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2018

ETS-FLEX60 ENDOSCOPIC ARTICULATING LINEAR CUT

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2018

NEU_ENTERRA_INS

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LNQ·July 16, 2018

ARROW ARTERIAL CATH SET: 18GA X 12CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·December 4, 2024