22 results · 21ms · Sources: EU EUDAMED, US FDA

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Icare HOME Tonometer

FDA 510(k)
FDA Class 2 ·Ophthalmic

MAYO SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896056107·MAYO SCISSORS WITH GOLD SCREW CURVED BEVELED TU...

CORTRAK 2

FDA UDI
CORPAK MEDSYSTEMS, INC.·10815149024636·Interconnect cable for CORTRAK 2

CORTRAK* Enteral Access System

FDA UDI
Avanos Medical, Inc.·00350770456591·CORTRAK* Enteral Access System - Reusable Cable

Halyard

FDA UDI
Avanos Medical, Inc.·10680651456592·HALYARD* CORTRAK* Enteral Access System - Reusa...

4631 DUO DELIVERY SYSTEM

FDA 510(k)
FDA Class 1 ·Dental

RPI REPLACEMENT HEATING ELEMENTS

FDA 510(k)
FDA Class 2 ·General Hospital

COBAS 8000 C 702 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 7, 2017

UNKNOWN PAIN PUMP PRODUCT

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS KALAMAZOO·Product code MEB·April 14, 2009

UNKNOWN DEEP BRAIN STIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 15, 2009

UNKNOWN DEEP BRAIN STIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 15, 2009

UNK DEEP BRAIN STIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 15, 2009

COBAS 8000 C 702 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 22, 2017

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·July 1, 2011

ANCHOR C DIAM.3.5MM SELF DRILLING 10MM

FDA Adverse Event
Malfunction ·STRYKER SPINE-SWITZERLAND·Product code OVE·July 2, 2013

COBAS 8000 C (701) MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 22, 2017

Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024