12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Single-Use Surgical Mask Model FE2311B
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112397·BARD-PARKER HANDLE #9
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
BD Q-SYTE EXT SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·July 31, 2024
ARCOS CON SZ B HI 60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 6, 2018
EV-3 STENT
FDA Adverse Event
Injury
·EV-3 THE ENDOVASCULAR COMPANY·Product code NIN·October 23, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·August 5, 2025
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015