19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EverLift Submucosal Lifting Agent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
FDA 510(k)
FDA Class 2
·Immunology
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
FDA 510(k)
FDA Class 2
·Cardiovascular
S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ ACCUSEAL TAP
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC, INC.·Product code EXH·September 17, 2014
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·August 11, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 2, 2013
EXCOR®
FDA Adverse Event
Injury
·BERLIN HEART GMBH·Product code DSQ·October 19, 2023
UNKNOWN COOL TIP ELECRTRODE
FDA Adverse Event
Death
·COVIDIEN MFG DC BOULDER·Product code GEI·December 11, 2024
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·August 20, 2024
P9 IMPELLA SWAN CL
FDA Adverse Event
Death
·ABIOMED, INC.·Product code OZD·July 21, 2025
MEDTRONIC ICD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·August 21, 2024
UNKNOWN COOL TIP ELECRTRODE
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·December 10, 2024
SENSOR UROLOGICAL GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZB·June 18, 2025
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 1, 2024
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