13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981298401·Iliac Tap, Cannulated, Navigated, 12.5mm
CADD
FDA UDI
ICU MEDICAL, INC.·15019517171969·
GE DATEX-OHMEDA AVANCE CS2
FDA 510(k)
FDA Class 2
·Anesthesiology
INTELLIVUE MX40 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CLINITEK STATUS+
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 17, 2024
NOVUM IQ
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·October 30, 2014
INTELLIVUE MULTI MEASUREMENT SERVER (MMS)
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. 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