12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS CHF TYPE Y0003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEONE SPA
FDA UDI
LEONE SPA·08033707065845·EXTRAORAL ELASTICS 3/8" 8 oz
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·November 27, 2024
MEDRELIEF
FDA 510(k)
FDA Class 2
·Neurology
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
FDA 510(k)
FDA Class 2
·Neurology
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·April 15, 2015
ASPHERE M SPEC 11/13 40 +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
WECK AUTOMATIC ENDO5 APPLIER, MEDIUM-LARGE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·April 6, 2011
BD PCR Cartridges used with MAX System. Model Number: 437519
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·January 29, 2025
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; 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