25 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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FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515234239·Hardy Bay Fcps, .5mm, insul, 8 1/2"
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019102749·Bipolar Coagulation Forceps 8 3/4" (22.2cm) Har...
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981029944·PRECONTOURED ROD, 5.5 x 35mm
EPOC READER
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code CGL·April 12, 2021
VALET MICRO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 7, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 21, 2024
CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·September 26, 2014
AXXESS QUAD LEAD 3/4MM, 30CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 14, 2008
CUSTOM TOTAL FEMUR REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·July 24, 2015
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·December 23, 2014
CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 1, 2014
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·August 8, 2012
PROXIMAL FEMUR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·December 23, 2014