13 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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DNA/RNA Shield Collection Tube
FDA 510(k)
FDA Class 2
·Microbiology
Cal OSHA - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal
Sklar®
FDA UDI
SKLAR CORPORATION·10649111166587·KILNER NEEDLE HOLDER 6 1/2"
FLEXCERA BASE
FDA Adverse Event
Malfunction
·ENVISIONTEC GMBH·Product code EBI·November 10, 2021
TOKUYAMA REBASE II
FDA 510(k)
FDA Class 2
·Dental
MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
FDA 510(k)
FDA Class 2
·Dental
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
HEARTSTART ONSITE
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·August 5, 2011
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING·Product code FJI·September 18, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
SILIC FOLEY CATH 5/10ML /5
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EZL·February 15, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012