16 results · 22ms · Sources: EU EUDAMED, US FDA

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COMPUMEDICS SIESTA SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040044988·Forcep Extracting

QUASAR

FDA UDI
Modus Medical Devices Inc·G34350031750·MP - IC Dummy Polystyrene - generic (covers any...

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159008746·Jacobson Micro Needle Holder Round Handle

TANTALUM BEAD SET, MODEL P003175

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

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540246110·PIVOTAL ALIGNMENT HANDLE

SERAGARD VASCULAR ACCESS PATCH

FDA 510(k)
FDA Class 2 ·General Hospital

HARDYDISK TICARILLIN 75MCG

FDA 510(k)
FDA Class 2 ·Microbiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 6, 2025

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·February 18, 2011

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 12, 2014

APTIMA HPV SCREENING ASSAY

FDA Adverse Event
Injury ·HOLOGIC, INC.·Product code OYB·May 15, 2025

Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.

FDA Enforcement
Class II ·Terminated·Greatbatch Medical·June 8, 2016

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024