29 results · 23ms · Sources: EU EUDAMED, US FDA

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NeuroBlate System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM

16PW - Krispy Kreme FAK - Poly White

FDA UDI
Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154731695·TENSION PLIER ONLY FOR MP SYSTEM

PERMACOL

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OLYMPIC WARM-UP

FDA 510(k)
FDA Class 2 ·Physical Medicine

Trilogy® Trabecular Metal®

FDA UDI
Zimmer, Inc.·00889024118522·

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2024

OPHTHALMIC FEMTOSECOND LASER

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021

PROPEX

FDA Adverse Event
Malfunction ·DENTSPLY MAILLEFER·Product code LQY·July 1, 2011

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 27, 2014

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2022

CATALYS PRECISION LASER SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021