21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zimmer Nexel Total Elbow Ulnar Cement Diverter
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I
ORTHOPEDIC SALVAGE SYSTEM (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304240131·
MONOPOLY/CONKLUSION
FDA UDI
SIGNUS Medizintechnik GmbH·04047844039946·The CONKLUSION Pedicle Screw System is a spinal...
LEONE SPA
FDA UDI
LEONE SPA·08033707069218·TWISTER FOR PREF LIG TIES
TIBIAL INSERT IMPACTOR TIP
FDA Adverse Event
Malfunction
·CONFORMIS, INC.·Product code OOG·April 28, 2017
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100158·KRATZ-BARRAQUER SPECULUM LARGE
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197456289·OESCH Phlebectomy hook
Fig. 1...
MULTIFUNCTIONAL LINEAR PEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 6, 2013
ACCOLADE PLUS TMZF HIP STEM #5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·June 23, 2011
ANGIO-SEAL DEVICE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·September 4, 2008
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code PNJ·June 27, 2022
MISAGO RX Self Expanding Peripheral Stem
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 7, 2016
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024