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

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Tapered Pro Conical Implant System

FDA 510(k)
FDA Class 2 ·Dental

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455547·Integra® Jarit® Cobb Style Bone Curette, Hollow...

Oticon

FDA UDI
Sbo Hearing A/S·05714464053100·OTICON ZIRCON 1 MINIRITE R C063

RAY STATION

FDA 510(k)
FDA Class 2 ·Radiology

MEDICINAL LEECHES

FDA 510(k)
FDA Unclassified ·Unknown

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949·Product code FMF·March 15, 2024

SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA

FDA Adverse Event
Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·July 11, 2024

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008

UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JGS·September 9, 2011

RESTORE ADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 22, 2013

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