FDA 510(k) Applications Submitted by CHARLIE MACK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080025 |
01/04/2008 |
LED.L, LED.M, LED.G, LED.B |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
| K100217 |
01/25/2010 |
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 |
MEDIANA CO., LTD. |
| K100225 |
01/26/2010 |
PULSE OXIMETER MODEL P10 |
MEDIANA CO., LTD. |
| K080553 |
02/28/2008 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 |
VIEWORKS CO., LTD. |
| K120773 |
03/14/2012 |
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM |
Covidien LLC |
| K100723 |
03/15/2010 |
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 |
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. |
| K060871 |
03/30/2006 |
AS101, BLOOD PRESSURE CUFF |
WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY |
| K140806 |
04/01/2014 |
IBS IMPLANT SYSTEM |
INNOBIOSURG CO., LTD |
| K140869 |
04/03/2014 |
DCAS I |
GP&P CO., LTD. |
| K110928 |
04/04/2011 |
BODY ANALYSIS SCALE, MODEL BG 17 |
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
| K111290 |
05/06/2011 |
PIEZO BONE SURGERY |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
| K131303 |
05/07/2013 |
DISPOSABLE CIRCULAR STAPLER |
CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO. |
| K111329 |
05/11/2011 |
NM-7000 |
NUGA MEDICAL CO., LTD |
| K091518 |
05/22/2009 |
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM |
MCUBE TECHNOLOGY CO., LTD. |
| K051375 |
05/26/2005 |
VITAL SIGNS MONITOR |
MEDIANA CO., LTD. |
| K121637 |
06/04/2012 |
AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE |
SUNWELL BIOTECH CO., LTD |
| K081587 |
06/05/2008 |
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 |
KRELL PRECISION (YANG ZHOU) CO., LTD. |
| K081951 |
07/09/2008 |
ANEROID SPHYGMOMANOMETER, MODEL KT-A01 |
WENZHOU KINDCARE IMPORT & EXPORT CO., LTD |
| K092081 |
07/09/2009 |
QXLINK |
VIEWORKS CO., LTD. |
| K112149 |
07/26/2011 |
WEIGHT AND BODY FAT SCALE SHINE BS0105 |
SHINE OVERSEAS MARKETING LIMITED |
| K112190 |
07/29/2011 |
PATIENT MONITOR |
MEDIANA CO., LTD. |
| K052190 |
08/11/2005 |
FETAL MONITOR, MODELS BT-300 AND BT-200 |
BISTOS CO., LTD. |
| K092546 |
08/19/2009 |
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM |
GMDASZ MANUFACTURING CO., LTD |
| K082410 |
08/21/2008 |
MASTER3DS |
E-WOO TECHNOLOGY |
| K102408 |
08/23/2010 |
DIGITAL DIAGNOSTIC X-RAY SYSTEM |
DRGEM CORPORATION |
| K052309 |
08/24/2005 |
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 |
SAEHAN CORP. |
| K092870 |
09/18/2009 |
NON-STERILE DISPOSABLE VAGINAL SPECULUM |
KUNSHAN DEYI PLASTIC CO., LTD. |
| K122976 |
09/26/2012 |
BODY FAT SCALE MODEL SF-371 |
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
| K093016 |
09/29/2009 |
VITAL SIGNS MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
| K123098 |
10/02/2012 |
XGEO GC80 |
SAMSUNG ELECTRONICS CO., LTD. |
| K123105 |
10/02/2012 |
XGEO GU60 |
SAMSUNG ELECTRONICS CO., LTD. |
| K123106 |
10/02/2012 |
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A |
SAMSUNG ELECTRONICS CO., LTD. |
| K112951 |
10/04/2011 |
BODY ANALYSIS SCALE |
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
| K063121 |
10/12/2006 |
PORTABLE X-RAY SYSTEM, MODEL PORT-X II |
GENORAY CO., LTD. |
| K073190 |
11/13/2007 |
SLIT LAMP |
HUVITZ CO., LTD. |
| K123711 |
12/04/2012 |
PATIENT MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
| K113587 |
12/05/2011 |
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) |
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. |
| K083640 |
12/09/2008 |
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D |
CHOONGWAE MEDICAL CORP. |
| K053555 |
12/20/2005 |
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
| K053629 |
12/29/2005 |
ANCHOR PLUS/NEO ANCHOR PLUS |
KJ MEDITECH |
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