25 results · 23ms · Sources: EU EUDAMED, 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