|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
vx1+
|
Volta Medical
|
K223516 |
01/21/2023
|
duetto suprema; domino suprema; suprema vt; suprema vt+; suprema 4v
|
Quanta System, S.p.A.
|
K223404 |
01/20/2023
|
flowart® needle-free split septum valve
|
Asset Medikal Tasarim San Tic As.
|
K222889 |
01/20/2023
|
highlander™ 014 pta balloon dilatation catheter
|
C.R. Bard, Inc.
|
K223177 |
01/20/2023
|
insupen pen needle, insupen original pen needle, insupen advanced pen needle
|
Pikdare S.p.A
|
K203792 |
01/20/2023
|
semi-automatic biopsy-needle (bim 18/20); semi-automatic biopsy-needle (bim 18.15); semi-automatic biopsy-needle (bim 18/10);semi-automatic biopsy-needle (bim 16/20);semi-automatic biopsy-needle (bim 16/15);semi-automatic biopsy-needle (bim 16/10);semi-automatic biopsy-needle (bim 14/20);semi-autom
|
ITP Innovative Tomography Products GmbH
|
K222462 |
01/20/2023
|
blueprint mixed reality system
|
Tornier SAS
|
K222510 |
01/20/2023
|
cysto-nephro videoscope (olympus cyf-v2), cysto-nephro videoscope (olympus cyf-v2r), cysto-nephro videoscope (olympus cyf-vh) and cysto-nephro videoscope (olympus cyf-vhr)
|
Olympus Medical Systems Corporation
|
K221683 |
01/20/2023
|
digital thermometer, model: dt007, dt008
|
Guangzhou Berrcom Medical Device Co., Ltd.
|
K214077 |
01/20/2023
|
gmk sphere & gmk spherika cementless
|
Medacta International S.A.
|
K223548 |
01/20/2023
|