20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VESOFLOW PLUS DVT COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265231·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971406·
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
FDA 510(k)
FDA Class 2
·Dental
BIOKNOTLESS RC ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106455·Porous Acetabular Cup System - Hemispherical Sh...
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569836·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569812·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638402·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638396·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638389·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569829·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638419·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569843·
MEDICAL CHAIR & TABLE
FDA Adverse Event
Injury
·CHAMPION MANUFACTURING·Product code INO·March 28, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 3, 2013
DEXTRUS 4135
FDA Adverse Event
Other
·BIOTRONIK SE & CO. KG·Product code NVZ·June 15, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. 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. 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
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021