30 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Disposable Monopolar Laparoscopic Tips and Reusable Handles
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551110446·HALO, 1203-5 VEST PED0, ACRYLIC LINER, 1211-1 X...
Maxim Ignite
FDA UDI
WESTRIDGE LABORATORIES INCORPORATED·00840281300082·MX24003 Maxim Ignite Personal Lubricant 4.4 fl ...
AED TC Gold
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657076531·AED TC Gold 21-1019 Plate Cutter
Maxim Pure
FDA UDI
WESTRIDGE LABORATORIES INCORPORATED·00840281300105·MX24001 Maxim Pure H20 4.4 fl oz Personal Lubri...
Maxim Premium Silicone
FDA UDI
WESTRIDGE LABORATORIES INCORPORATED·00840281300099·MX24002 Maxim Premium Silicone 4.4 fl oz Person...
N/A
FDA UDI
Smith & Nephew, Inc.·00817470001150·DRILL-TIP GUIDEWIRE 254MM(10IN)LX2.4MMD
Straight Plate, 2.0mm
FDA UDI
I.T.S. GmbH·09120034303043·Straight Plate, 2.0mm, 9-Hole
BD PLASTIPAK ¿ - 3-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·May 2, 2023
SURGIMAP (TM) SPINE
FDA 510(k)
FDA Class 2
·Radiology
OPTIMA NM/CT 640
FDA 510(k)
FDA Class 2
·Radiology
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
SETROX S 60
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·October 29, 2014
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 13, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
MINDRAY
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·August 4, 2022
BD MICROLANCE¿ STAINLESS STEEL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 24, 2022
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026