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