13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAGITTILT
FDA 510(k)
FDA Class 2
·Radiology
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304232976·
DUOLINK II
FDA 510(k)
FDA Class 2
·Dental
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
UNSPECIFIED PRIMARY PLUM SET
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 4, 2014
UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024
BD LUER-LOK 1-ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·June 2, 2023
PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 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