21 results · 22ms · Sources: EU EUDAMED, 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