11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWERPLAY MUSCLE MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
Z Liquid HT C4-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818122154·Dental porcelain/ceramic restoration kit
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
FDA 510(k)
FDA Class 2
·Radiology
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 14, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 19, 2018
DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 30, 2026
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·May 17, 2013
ESSENCE COMPRESSOR
FDA Adverse Event
Malfunction
·RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.·Product code CAF·September 18, 2014
ISOLINE
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA CRM S.R.L.·Product code MRM·June 13, 2011
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