16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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