19 results
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30ms
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Sources: EU EUDAMED, US FDA
ELECSYS DHEA-S
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Premier Curettes
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783007848·CURETTE MOLT 6R
EndoGator Hybrid
FDA UDI
MEDIVATORS INC.·00724995224134·EndoGator Tubing Hybrid, Fuji 500 is used with ...
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008739·Jacobson Micro Needle Holder Round Handle
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114049·J-SHAPED CANNULA 25GA STRAIGHT (PK/10)
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
YPSOPUMP® INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
YPSOPUMP® INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
YPSOPUMP® INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
YPSOPUMP® INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
YPSOPUMP® INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
COSMED QUARK
FDA 510(k)
FDA Class 2
·Anesthesiology
ACTION AF-1 WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 12, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 28, 2011
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