13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Human Microalbumin kit for use on SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
HYDROGUM SOFT
FDA 510(k)
FDA Class 2
·Dental
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOPATCH 10152 PACK OF 500
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code FRO·September 25, 2015
NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR4 - 12
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·May 29, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 28, 2011
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 6, 2014
VALEO / VALEO II
FDA Adverse Event
Malfunction
·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 15, 2019
UNKNOWN KNEE FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 15, 2019
UNKNOWN KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 15, 2019
PKG, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025