48 results · 21ms · Sources: EU EUDAMED, US FDA

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AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300119·

COOLEY VASCULAR CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·B09921002420·COOLEY VASCULAR CLAMP

LEONE SPA

FDA UDI
LEONE SPA·08033707092841·BKT 42 F1000 SELF LIGATING 22

METZENBAUM SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046788·METZENBAUM SCISSORS CURVED BLADE

COOLEY VASCULAR CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002081·COOLEY VASCULAR CLAMP

ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE

FDA 510(k)
FDA Class 2 ·Orthopedic

COOK ZILVER BILIARY STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 25, 2019

T:FLEX INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·September 6, 2019

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 18, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 16, 2011

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·October 7, 2024

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·October 8, 2024

SURSHIELD PUR SAFETY I.V. CATHETER

FDA Adverse Event
Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

M2A-MAGNUM 42-50MM TPR INSRT-3

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 13, 2012

Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E

FDA Enforcement
Class II ·Terminated·ConvaTec, Inc·June 14, 2017

SOMATOM Confidence -Computed tomography systems Model 10590100

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

SOMATOM Confidence with software syngo.CT VB20 Model #10590100

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021