23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRIGEN INTERTAN
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743656·ACHIMED ACHILLES SUPP SILVER II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743489·LEVAMED ANKLE SUPPORT SILVER II
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00816777026712·
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481475630·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023956·PADDLE SPREADER, 12MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102120·Shaver, Open 12mm
Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795009661·BOW & Arrow, Evans Plate, 12mm Wedge
OFFSET TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
KSEA CHARDONNES MORCELLATION KNIFE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
NAOS
FDA UDI
HNM TOTAL RECON LLC·00841742101064·NAOS First MPJ Hemi, Porous Coated, CC - S, 17mm
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981173562·Trial LTL, 13x12x12mm, Flat 7 Deg
B-P TOTAL SHOULDER SYSTEM
FDA UDI
ENDOTEC, INC.·00814193025395·B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2025
RADICAL
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·April 16, 2015
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 8, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·April 5, 2011
PUMP MMT-722LCAS PRDGM INS SK EN LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·May 8, 2008
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
FDA Recall
Terminated
·bioMerieux·Product code LJC·August 6, 2003
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014