12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UltraThineer Zirconia Slurry (5Y-B)
FDA 510(k)
FDA Class 2
·Dental
Lullaby Double Electric Breast Pump
FDA UDI
ARISE MEDICAL LLC·00372217020011·Lullaby Double Electric Breast Pump
DYNAGRAFT II
FDA 510(k)
FDA Class 2
·Orthopedic
SUPERCATH5
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
G3 PLUS AUTO, AED, ENGLISH, PKG
FDA Adverse Event
Malfunction
·CARDIAC SCIENCE CORPORATION·Product code MKJ·April 2, 2026
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 25, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
2.5MM X 25.4MM FLUTED ROUTER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·May 16, 2024
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code PHX·August 7, 2025
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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