51 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILHOUETTE FC
FDA 510(k)
FDA Class 2
·Radiology
Proteus XR/a (SlOK : K993090)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KPR·August 9, 2019
Proteus XR/a (SlOK : K993090)
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·October 2, 2019
Walgreens
FDA UDI
WALGREEN CO.·00311917194028·Full Adhesive Heat Wraps Neck, Shoulder & Wrist...
artegral life
FDA UDI
Merz Dental GmbH·D7091993090·anteriors; shade A3; mould UBM
HCG Zirconia Ceramic Block
FDA 510(k)
FDA Class 2
·Dental
GALILEOS IMPLANT, VERSION 1.7
FDA 510(k)
FDA Class 2
·Radiology
SUPRAMID BLACK 5/0 (1) 45CM DS16
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·January 17, 2019
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 7, 2013
COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 16, 2011
MYOCARDIAL LEAD
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
SUPRAMID WHITE 2/0 (3) 100M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·November 4, 2019
SUPRAMID BLACK 4/0 (1.5) 45CM HS15
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·July 31, 2019
DAFILON BLUE 2/0 (3) 75CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·July 1, 2019
DAFILON BLUE 4/0 (1.5) 45CM DS16 (M)
FDA Adverse Event
Injury
·B.BRAUN SURGICAL SA·Product code GAR·October 15, 2019
DAFILON BLUE 2/0 (3) 75CM DS30
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·October 4, 2019
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·October 26, 2016
SUPRAMID BLACK 2/0 (3) 5X45CM
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAR·August 20, 2020
SUPRAMID BLACK 4/0 (1.5) 45CM DS16
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·May 15, 2019
FLEXOCRIN 6/0 (0.7) 60CM DS9
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·June 5, 2019