11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UltraLinq
FDA 510(k)
FDA Class 2
·Radiology
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205857·
MAXIM® VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225925·
FREQUENCER
FDA 510(k)
FDA Class 2
·Anesthesiology
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 17, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 25, 2014
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
EEA XL 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC·Product code GDW·May 24, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 28, 2011
PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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