FDA 510(k) Applications Submitted by Albert Rego
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060037 |
01/06/2006 |
FITPACK |
ASP PLASTICS PTY LTD. |
| K100139 |
01/19/2010 |
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 |
SAFELIFE CORP. |
| K030662 |
03/03/2003 |
PATHWAY ACCESS SHEATH CATHETER |
VERTELINK CORPORATION |
| K030734 |
03/10/2003 |
PATHWAY ACCESS SHEATH CATHETER |
VERTELINK CORPORATION |
| K110835 |
03/25/2011 |
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS |
GEO MEDICAL CO., LTD. |
| K090867 |
03/31/2009 |
AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 |
EP DYNAMICS, INC. |
| K061009 |
04/12/2006 |
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS |
ONSET MEDICAL CORPORATION |
| K111603 |
06/08/2011 |
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM |
EP DYNAMICS, INC. |
| K051576 |
06/14/2005 |
AVANA DENTAL IMPLANT SYSTEM |
OSSTEM CO., LTD. |
| K191594 |
06/17/2019 |
Nuvis Battery Arthroscope |
Integrated Endoscopy, Inc. |
| K121857 |
06/26/2012 |
FEMMYCYCLE |
FEMCAP INCORPORATED |
| K141767 |
07/01/2014 |
ID MILLENNIUM, ID MOMENTS SILICONE |
WESTRIDGE LABORATORIES, INC. |
| K072069 |
07/30/2007 |
SPACER |
VERICOM CO., LTD. |
| K072213 |
08/09/2007 |
PERIMETRICS PERIOMETER |
PERIMETRICS, INC. |
| K042308 |
08/25/2004 |
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 |
FACILE MEDICAL, INC. |
| K062852 |
09/25/2006 |
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 |
ONSET MEDICAL CORPORATION |
| K042859 |
10/15/2004 |
KOBRA GPS FIXATION SYSTEM |
MEDTRONIC VERTELINK, INC. |
| K133206 |
10/17/2013 |
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM |
ZUMA DENTAL, LLC |
| K123431 |
11/07/2012 |
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D |
DREAMCON CO., LTD |
| K043254 |
11/24/2004 |
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH |
ONSET MEDICAL CORPORATION |
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