12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREDDO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295122975·STERILIZATION TRAY LOWER
NOVASYS TRANSURETHRAL RF SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POOL NORM
FDA 510(k)
FDA Class 2
·Hematology
GLIDEWELL HT IMPLANT Ø3.5 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 17, 2025
TI END CAP T40 STARDRIVE 0MM EXT FOR FEMORAL NAILS-EX
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KTT·December 31, 2012
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 16, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
Z-LOOK3
FDA Adverse Event
Injury
·Z-SYSTEMS AG·Product code DZE·November 23, 2015
PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. 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
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020