21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NobelProcera HT ML FCZ Implant Bridge and Framework
FDA 510(k)
FDA Class 2
·Dental
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486009465·MCK FEMORAL TEMPLATE (SIZE 8 RM/LL)
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821601580·SCISSORS, SURGICAL TISSUE, DENTAL
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·December 16, 2015
LeMaitre Embolectomy Catheter
FDA UDI
Lemaitre Vascular, Inc.·00840663100620·5F 80 cm LeMaitre Embolectomy Catheter, eIFU
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044471·Unitek(TM) Molar Band General Purpose Narrow Re...
LeMaitre Embolectomy Catheter
FDA UDI
Lemaitre Vascular, Inc.·00840663100514·5F 80 cm LeMaitre Embolectomy Catheter
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290129·Denovo general purpose dental molar band - Maxi...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450095072·
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DXE·October 21, 2015
SINGLE LUMEN EMBOLECTOMY CATHETER
FDA Adverse Event
Other
·Product code DXE·August 2, 2007
ILLUMINATING SINUS SEEKER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NET-2000 MICROCURRENT STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
SINGLE LUMEN EMBOLECTOMY CATHETER
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code DXE·November 7, 2005
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 18, 2014
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 10, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 13, 2011
PARADIGM REAL -TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
BAROUK SCREW - 3 0MM X 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020