11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Agility Symmetric Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NKM·July 7, 2017
ClearRT Helical kVCT for the Radixact Treatment Delivery System
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED SPACEMAKER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
10MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·August 14, 2019
ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·November 24, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013
TMC SPEEDMTP
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025