18 results
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21ms
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Sources: EU EUDAMED, US FDA
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
FDA 510(k)
FDA Class 2
·Dental
Oticon
FDA UDI
Oticon A/S·05707131270313·H11, DESIGNRITE 10 WL PLI
UniTip Catheter
FDA UDI
Unisensor AG·07640172971444·
SMITH & NEPHEW MDF MODULAR SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
FDA 510(k)
FDA Class 2
·Cardiovascular
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 17, 2019
GMK REVISION SC LINER SIZE 4 - 14 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 20, 2015
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·May 31, 2013
INTEGRITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026
INTELLAMAP ORION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024
GMK-REVISION FEMUR REVISION PS SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 8, 2016
PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. 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
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015