12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357239269·
1ML 31GX6MM U-100 INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 21, 2021
METASURG NITINOL STAPLE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Spectra Wearable
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELION INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·December 21, 2020
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·August 18, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 12, 2013
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·April 20, 2016
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026