|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
vitek® 2 streptococcus tetracycline (<=0.25 - >=16 µg/ml)
|
bioMerieux, Inc
|
K223481 |
02/03/2023
|
14f isleeve™ introducer set
|
Boston Scientific Corporation
|
K230051 |
02/03/2023
|
acupebble ox100
|
Acurable Limited
|
K222950 |
02/03/2023
|
duoblade
|
CnC Technologies
|
K220996 |
02/03/2023
|
manta ray tdf spacer
|
SeaSpine Orthopedics Corporation
|
K220296 |
02/03/2023
|
microlife upper arm automatic digital bpm, model watchbp office vascular (twin200 vsr)
|
Microlife Intellectual Property GmbH
|
K222153 |
02/03/2023
|
cook® spectrum® 2 mrc central venous catheter
|
Cook Advanced Technologies
|
K223648 |
02/03/2023
|
gaiabone bioabsorbable bone graft
|
Corliber (Shenzhen) Medical Device Co., Ltd.
|
K220337 |
02/03/2023
|
luna dental implant system
|
Shinhung MST Co., Ltd
|
K223395 |
02/03/2023
|
montage settable, resorbable bone putty
|
Orthocon, Inc.
|
K222063 |
02/03/2023
|