13 results
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20ms
·
Sources: EU EUDAMED, US FDA
S. AUREUS PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
FDA 510(k)
FDA Class 2
·General Hospital
ORTELIUS 800
FDA 510(k)
FDA Class 1
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2024
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
M2A 38MM MOD HD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 16, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 17, 2011
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·May 7, 2019
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 14, 2017
VENTRALIGHT ST MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 9, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020