|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
WALLAC NEONATAL BIOTINIDASE TEST KIT, MO
|
WALLAC, INC. |
DEN990008 |
K992284 |
02/15/2000 |
THE 3PM EGG MACHINE
|
3PM CO., INC. |
DEN990005 |
K984637 |
08/20/1999 |
KAVO DIAGNODENT
|
KAVO AMERICA |
DEN990002 |
K983658 |
02/22/2000 |
DIAMOND PROBE/PERIO 2000 SYSTEM
|
DIAMOND GENERAL DEVELOPMENT CORP. |
DEN980003 |
K980749 |
07/17/1998 |
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC
|
CRANIAL TECHNOLOGIES, INC. |
DEN980001 |
K964992 |
05/29/1998 |
BraidE Embolization Assist Device
|
Rapid Medical Ltd. |
DEN230064 |
|
02/21/2024 |
Eversense AP CGM System
|
Senseonics, Incorporated |
DEN230052 |
|
04/29/2024 |
Body Temperature Software (BTS)
|
Fitbit LLC |
DEN230050 |
|
12/15/2023 |
Sonu
|
Sound Health Systems, Inc. |
DEN230045 |
|
12/04/2023 |
Sleep Apnea Feature
|
Samsung Electronics Co., Ltd |
DEN230041 |
|
02/06/2024 |