12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zio AT ECG Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150532·16F x 3.5cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071147914·16F x 3.5cm MiniSPC Low Profile Suprapubic Cath...
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LEKSELL GAMMA KNIFE PERFEXION
FDA 510(k)
FDA Class 2
·Radiology
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 10, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 11, 2013
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·June 2, 2011
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024