21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
FDA 510(k)
FDA Class 2
·Immunology
Closed Wound Suction
FDA UDI
C. R. Bard, Inc.·00801741049620·ReliaVac 100 Closed Wound Suction Evacuator, Lo...
AS1 Dr./Asst Rear Delivery
FDA UDI
Engle Dental Systems, LLC·00850043433033·Wall mount 12 o'clock rear delivery dual purpose
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070900·MISS RELAX 140 OPEN TOE, SIZE S, NERO, GRADUATE...
Tetra-Net
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138103276·TETRA-NET ELASTIC DRESSING RETAINER SIZE 8
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702368789·ELVAREX 3/KNEE HIGH/OPEN TOE/GREY
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702407655·Elvarex 2/Knee High/Slant-Open Toe/Dotted 2,5 c...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702245387·Elvarex 2/Thigh High/Open Toe-Elephantiasis-Ver...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702542639·ELVAREX FORTE 3/KNEE HIGH/PROFILE-SLANT-CLOSED ...
STS-T LITHOTRIPTER, MODEL STS-T
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2010 RACK ELECSYS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 6, 2007
EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code BSO·April 30, 2020
MEDSTONE LITHOTRIPTOR
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017
EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code BSO·April 30, 2020
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 9, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018
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