14 results
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22ms
·
Sources: EU EUDAMED, US FDA
PRO Pen Microneedling System (6883)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tubing, Smooth Interior, Disposable
FDA UDI
A-M SYSTEMS, LLC·00817081024746·Tubing, Smooth Interior, Disposable, 1.375"-72"
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101247·WILLS EYE SPUD AND BURR
Bar Phantom
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175003800·Bar Phantom, Standard, High Resolution
SyntrFuge System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Artiglass NRFitTM Tip L.O.R. Glass Syringes
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 24, 2008
INTRALASE PATIENT INTERFACE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·September 1, 2011
TOTAL ASR ACET IMP SIZE 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·July 23, 2013
PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800
FDA Enforcement
Class II
·Terminated·Midmark Corp dba Progeny Inc·January 15, 2014
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800
FDA Recall
Terminated
·Midmark Corp dba Progeny Inc·Product code MUH·September 20, 2013