19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SECURE ARTERIAL BLOOD SAMPLING SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507393·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802171·Mixter Hemostatic Forceps, Strongly Curved, 14 cm
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481475272·
HYSTALOG HSG CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 25, 2021
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 18, 2025
HYPERGLIDE
FDA Adverse Event
Malfunction
·COVIDIEN (IRVINE)·Product code MJN·March 29, 2017
HYPERGLIDE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MJN·March 29, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
GE OEC 8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
BASIC CONFIGURATION MODEL 6100 KNEE GATCH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 18, 2011
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·June 27, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022