17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stryker Omega PEEK Knotless Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112908·CORNEAL TREPHINE BLADE7.25MM
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184117·Accufit Molar Bands Lower Left Second Molar 35 1/2
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112489·BARRON VACUUM TREPHINE 7.25MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113394·MICS TRAP KNIFE 1.8/2.2 (BX/5)
ATOM INFA WARMER V-505
FDA 510(k)
FDA Class 2
·General Hospital
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 9, 2022
NEEDLE 21X2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 7, 2021
INFINIA HAWKEYE 4
FDA Adverse Event
Death
·GENERAL ELECTRIC (GE) HEALTHCARE·Product code KPS·June 13, 2013
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 16, 2008
CLARION
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·August 8, 2011
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022
BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·December 22, 2022
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
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