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

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VENOTRAIN CURAFLOW

FDA 510(k)
FDA Class 2 ·General Hospital

Bone cutters

FDA UDI
DFS - DIAMON GmbH·04057176148179·Bone Cutter type 166 HP

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317347558·

SYNAPSE 3D BASIC TOOLS

FDA 510(k)
FDA Class 2 ·Radiology

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL

FDA 510(k)
FDA Class 2 ·Immunology

FIBULA COMP LOCK PLATE 10H STE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·August 24, 2016

CORONOID PLATE RT STE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·June 9, 2016

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·May 14, 2013

ITREL 3

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·August 13, 2008

RF3000 RADIOFREQUENCY GENERATOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·June 2, 2011

S3 SHOULDER PLATE 4 HOLE RIGHT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013

OPEN-END FLEXI-TIP URETERAL CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KOD·February 6, 2020

OPEN-END URETERAL CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KOD·February 7, 2020

OPEN-END URETERAL CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KOD·December 5, 2019

PROXIMATE*HCS HEMORR CIR STAPL

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2019

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021