22 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Video Endoscopy System, 3D Video Endoscopy System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Smith and Nephew
FDA UDI
Provision·B504OM72101160·
TWINFIX
FDA UDI
Smith & Nephew, Inc.·03596010482563·TWINFIX PREMIUM KNOT MANIPULATOR,
...
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022487·FM1 - Keyhole
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101160·Distractor, Smooth Paddle, Lordotic, 16mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101160·Distractor, Smooth Paddle, 16mm
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024831·B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCO...
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
FDA 510(k)
FDA Class 2
·Radiology
XEROS DRY MOUTH PUMP
FDA 510(k)
FDA Unclassified
·Unknown
Widex
FDA UDI
Widex A/S·05706069914559·WIDEX MOMENT MRB2D (Dark cherry ) 110, Telecoil...
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·July 3, 2020
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 22, 2008
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
NOVOSTITCH PRO MENISCAL RPR SYS 0
FDA Adverse Event
Injury
·CETERIX ORTHOPAEDICS, INC·Product code GAT·March 24, 2022
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
FDA Enforcement
Class II
·Terminated·Myco Medical Supplies Inc·March 6, 2013
LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 6.5mm x 35mm; f. 6.5mm x 40mm; g. 6.5mm x 45mm; h. 6.5mm x 50mm; i. 6.5mm x 55mm; j. 7.5mm x 35mm; k. 7.5mm x 40mm; l. 7.5mm x 45mm; m. 7.5mm x 50mm; n. 7.5mm x 55mm; o. 8.5mm x 35mm; p. 8.5mm x 40mm; q. 8.5mm x 45mm; r. 8.5mm x 50mm; s.8.5mm x 55mm; t. 9.5mm x 35mm; u. 9.5mm x 40mm; v. 9.5mm x 45mm; w. 9.5mm x 50mm; x. 9.5mm x 55mm; Used in spinal fixation surgery.
FDA Enforcement
Class II
·Terminated·Integrity Implants Inc.·December 14, 2022
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025