14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
FDA 510(k)
FDA Class 2
·Dental
D-Fine Double Diamond™ Final High Shine Refill #06
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001939·Dental burnisher
D-Fine Double Diamond™ Final High Shine Refill #06
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003708·Dental burnisher
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000264·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000271·
K2M General Instruments
FDA UDI
VB Spine LLC·10888857561434·Parallel Rasp Size 12x12x9 mm
MIXED MEDIA MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
BUTTON SWITCH PENCIL
FDA Adverse Event
Malfunction
·MEGADYNE MEDICAL PRODUCTS, INC·Product code GEI·June 10, 2011
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·October 31, 2005
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024