FDA 510(k) Applications Submitted by Annie Annie
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K203418 |
11/19/2020 |
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) |
Ningbo Ouhan Medical Device Co., Ltd. |
| K223544 |
11/25/2022 |
LED light therapy mask (FM-01, FM-02, FM-03) |
Guangdong Newdermo Biotech Co.,Ltd |
| K060163 |
01/23/2006 |
CARDIOFLON, CARDIOXYL |
PETERS SURGICAL |
| K060465 |
02/22/2006 |
PREMIO |
PETERS SURGICAL |
| K062366 |
08/14/2006 |
OPTIME, SINUSORB PGA |
PETERS SURGICAL |
| K052701 |
09/28/2005 |
COROLENE |
PETERS SURGICAL |
| K081232 |
05/01/2008 |
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES |
PRAXIM |
| K982860 |
08/13/1998 |
UM-L20/ UM-L30 |
UNION MEDICAL ENGENEERING CO., LTD. |
| K000222 |
01/24/2000 |
UM-L25 |
UNION MEDICAL ENGENEERING CO., LTD. |
| K981310 |
04/10/1998 |
MAGNATEK C-300 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K981416 |
04/20/1998 |
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K981430 |
04/20/1998 |
UNION MEDICAL UM-D30 COAGULATOR |
SHE MEDICAL, INC. |
| K991819 |
05/27/1999 |
MAGNATEK 30 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K981908 |
06/01/1998 |
UM-150A |
UMECO UNION MEDICAL ENGINEERING |
| K012071 |
07/02/2001 |
ENT LASERVISION |
UNION MEDICAL USA |
| K982405 |
07/10/1998 |
MTEK-1000 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K982846 |
08/12/1998 |
MTEK-1400 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K982907 |
08/18/1998 |
MAGNATEK 40 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K983114 |
09/04/1998 |
MAGNATEK80 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K963985 |
10/04/1996 |
UM-D3000/UM-D4000 |
J.J. CONSULTING SERVICES, INC. |
| K120198 |
01/23/2012 |
LOCATOR OVERDENTURE IMPLANT SYSTEM |
ZEST ANCHORS, LLC |
| K151789 |
07/01/2015 |
LOCATOR F-Tx Attachment System |
ZEST ANCHORS, LLC |
| K062298 |
08/08/2006 |
APOLLO GAMMA CAMERA SYSTEM |
ADAC LABORATORIES |
| K183230 |
11/20/2018 |
OneDraw A1C Test System |
Drawbridge Health, Inc. |
| K150295 |
02/06/2015 |
LOCATOR RTx |
ZEST ANCHORS, INC. |
|
|
