12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
FDA 510(k)
FDA Class 2
·Ophthalmic
CS 8100 CS 8100 ACCESS
FDA 510(k)
FDA Class 2
·Dental
ECLIPSE 6.5
FDA 510(k)
FDA Class 2
·Radiology
HEMOSPRAY ENDOSCOPIC HEMOSTAT
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code QAU·June 28, 2022
MIO¿ ADVANCE
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·May 8, 2025
SYNVISC
FDA Adverse Event
Injury
·Product code MOZ·October 23, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025