12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure Kits
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550131·GENUMEDI PT KNEE SUP SILVER L EW IV
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277132956·Cheng Trephine 18mm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973102069·Poly Insert MPCS, Size 6L, 14mm
S&C-SELF ETCH PR-BOND
FDA 510(k)
FDA Class 2
·Dental
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 14, 2024
LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·October 2, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·March 21, 2013
NONE
FDA Adverse Event
Malfunction
·KENSTONE METAL·Product code ITJ·June 21, 2011
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 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