|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Zuno Smart Sterilization Container
|
Zuno Medical, Inc. |
DEN210004 |
|
06/17/2022 |
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELI
|
KRONUS MARKET DEVELOPMENT ASSOCIATES, IN |
DEN140001 |
|
08/20/2014 |
ZIKV Detect 2.0 IgM Capture ELISA
|
InBios International, Inc. |
DEN180069 |
|
05/23/2019 |
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
|
ZELTIQ AESTHETICS |
DEN090002 |
K080521 |
08/24/2010 |
ZAP-IT!
|
ECOBRANDS LTD. |
DEN100024 |
|
11/07/2014 |
ZANZA-CLICK
|
TECNIMED S.R.L. |
DEN130019 |
|
11/07/2014 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
DEN130003 |
K121454 |
01/14/2013 |
XSTAT
|
REVMEDX, INC. |
DEN130016 |
K130218 |
04/03/2014 |
X-RAY ATTENUATING CREAM
|
BLOXR CORPORATION |
DEN120022 |
K123422 |
05/09/2013 |
XPERT MTB/RIF ASSAY
|
CEPHEID |
DEN130032 |
K131706 |
07/25/2013 |