17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Uroject12 Syringe Lever
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638830·CoRoent Ant TLIF PEEK, 8x10x34mm 15°
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239724·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304479418·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776367732·Yasargil Bayonet Tumor Forceps, 5mm sharp cut c...
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197453073·CCR Titanium Lateral Blade
24x45m...
SCANVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SYSTEMS INTEGRATION MODEL: ENDOALPHA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 20, 2013
NXT DETACHABLE COIL, TETRIS
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·July 27, 2011
WECK HEMOLOK L CLIPS 6/CART 84/BOX
FDA Adverse Event
Malfunction
·TELEFLEX·Product code MCH·October 15, 2014
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022