37 results
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26ms
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Sources: EU EUDAMED, US FDA
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950022656·SUCTION TIP MCKESSON TYPE TIP OPENING 3MM 9" 23CM
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746096624·DB BKT MASTER IBD UR CUSP 018 T-7 A+10 R=0
OsteoVation
FDA UDI
SKELETAL KINETICS LLC·00813845020023·OsteoVation EX Inject Bone Void Filler
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746094514·DB BRACKET MASTER SERIES MAX RIGHT CUSPID 018 T...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659210264·Bone wire in coils of 10m _x000D_...
Bone wire in coils of 10m 0.5mm
FDA UDI
mahe medical gmbh·EMAH00409000050·Bone wire in coils of 10m
0.5mm
900-005 Cleft Chin Sizer Set
FDA UDI
IMPLANTECH ASSOCIATES, INC.·M7249000051·Chin Sizer Set
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376513263·3/16 Tq Lm Ax Handle, 5in-lb, Grn
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BRANEMARK INTEGRATION BIOHELIX IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
SYNCARDIA COMPANION 2 DRIVER
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, LLC·Product code LOZ·November 19, 2019
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 27, 2014
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 7, 2013
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·October 22, 2010
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
FDA Enforcement
Class II
·Ongoing·CUE HEALTH INC·October 23, 2024
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
SYNCARDIA COMPANION 2 DRIVER
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 21, 2017
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 25, 2018