41 results · 26ms · Sources: EU EUDAMED, US FDA

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IDS Cortisol

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM

Conventional Lead Apron .5mm Xtra Xtra Large 26 X 42

FDA UDI
Flow X Ray Corporation·00843696123895·Conventional Lead Apron .5mm XXL 26 X 42, Hunte...

Tissue Holder

FDA UDI
KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC

Fluid Retention Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM

VESSEL GUARDIAN

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Shear Wave Quantificational Ultrasound Diagnostic System

FDA 510(k)
FDA Class 2 ·Radiology

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·October 6, 2021

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

THERASPHERE Y-90 (10.5 GBQ) CN CLINICAL

FDA Adverse Event
Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·January 24, 2022

RESTOR APODIZED IOL

FDA Adverse Event
Injury ·ALCON·Product code MFK·October 14, 2008

CARELINK PROGRAM W/TELEMETRY C

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code DXY·August 11, 2011

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 2, 2013

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

FDA Enforcement
Class I ·Terminated·B Braun Medical Inc·May 11, 2016

GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·August 19, 2021

ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·October 6, 2021

COREVALVE TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 12, 2021

FREEZOR XTRA CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code LPB·November 2, 2021

ABSORBABLE GELATIN

FDA Adverse Event
Injury ·PFIZER, INC.·Product code LMF·June 25, 2021

ENDOLOOP LIGATURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GEA·October 6, 2021