24 results · 20ms · Sources: EU EUDAMED, US FDA

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Cito CBC System

FDA 510(k)
FDA Class 2 ·Hematology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517631145·CoRoent Ant TLIF Ti, 14x10x40mm 12°

Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct

FDA UDI
ARISE MEDICAL LLC·00372217007043·Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct

Holder, Needle, TC, acc. Lemmon 19.5cm

FDA UDI
Geister Medizintechnik GmbH·04057034066331·Holder, Needle, TC, acc. Lemmon 19.5cm...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776300036·10mm 29cm Bugge Suction, medium

ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT

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

MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

AUTOPULSE NXT QUICK CASE

FDA Adverse Event
Injury ·ZOLL CIRCULATION, INC.·Product code DRM·April 9, 2025

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·February 1, 2013

S-ICD SYSTEM

FDA Adverse Event
Injury ·CAMERON HEALTH·Product code NVY·October 30, 2014

CPS COURIER

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DQY·September 9, 2011

4MM FLUTED BALL

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

EasyPoint Needle, 25G x 5/8", REF: 82091

FDA Enforcement
Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

FDA Enforcement
Class I ·Ongoing·Conavi Medical Inc.·April 30, 2025

BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020