12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRM TOOL Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114261·CHAMBER MAINTAINER 23GA (PK/10)
ZENOFLEX DIMENSION
FDA 510(k)
FDA Class 2
·Dental
CLEAN SCRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 21, 2022
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
SURE STEP PRO
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 26, 2008
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 3, 2013
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·August 17, 2022
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·August 22, 2022
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