21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112571·BARRON CORNEAL PUNCH 6.5MM
MindsEye Expandable Port
FDA 510(k)
FDA Class 2
·Neurology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112465·BARRON VACUUM TREPHINE 6.5MM
10PW - General Purpose
FDA UDI
Certified Safety Manufacturing, Inc.·00766588020129·10PW - General Purpose
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROLITE VL PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·December 4, 2022
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024119161·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024119178·
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·December 4, 2022
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·January 18, 2016
TRULIANT TIB IMP CR STD, SIZE 3, 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 7, 2023
BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 14, 2023
DUOVISC UNKNOWN
FDA Adverse Event
Injury
·ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V.·Product code LZP·August 5, 2011
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 27, 2013
MENTOR BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR, INC·Product code FWM·October 10, 2008
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020