FDA 510(k) Applications Submitted by Eric Ke
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980675 |
02/20/1998 |
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME |
SUMMIT TECHNOLOGY, INC. |
| K100840 |
03/24/2010 |
EMBO PLUS EMBOLECTOMY CATHETER |
HOTSPUR TECHNOLOGIES |
| K100842 |
03/25/2010 |
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM |
HOTSPUR TECHNOLOGIES |
| K121964 |
07/05/2012 |
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML |
AUGMENIX , INC. |
| K082093 |
07/24/2008 |
BULLSEYE BILIARY STENT SYSTEM |
SQUAREONE |
| K132917 |
09/17/2013 |
OCULAR FORCE GAUGE |
OCULAR THERAPEUTIX, INC. |
| K042588 |
09/22/2004 |
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 |
CONFLUENT SURGICAL,INC |
| K113769 |
12/22/2011 |
GPSCATH BALLON DILATATION CATHETER |
HOTSPUR TECHNOLOGIES |
| K140351 |
02/11/2014 |
ARROW GPSCATH BALLOON DILATATION CATHETER |
HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX ME |
| K130397 |
02/19/2013 |
ARROW GPSCATH BALLOON DILATATION CATHETER |
HOTSPUR TECHNOLOGIES |
| K102482 |
08/30/2010 |
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM |
OSTIAL CORPORATION |
| K143093 |
10/28/2014 |
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) |
HOTSPUR TECHNOLOGIES, INC., |
| K180388 |
02/13/2018 |
Transcend 365 miniCPAP System |
Somnetics International, Inc. |
| K213891 |
12/14/2021 |
RealNow |
YIWEI Medical Technology Co., Ltd |
| K013061 |
09/11/2001 |
BIOTOUCH MASSAGE THERAPY SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
| K231556 |
05/30/2023 |
SPECTRUM« GV Bone Cement |
OsteoRemedies, LLC |
| K191981 |
07/24/2019 |
REMEDY Acetabular Cup |
OsteoRemedies, LLC |
| K242377 |
08/09/2024 |
REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component |
OsteoRemedies, LLC |
| K172906 |
09/22/2017 |
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement |
OsteoRemedies, LLC |
| K192995 |
10/25/2019 |
OsteoRemedies Hip Spacer System |
OsteoRemedies, LLC |
| K223650 |
12/06/2022 |
REMEDY Stemmed Knee Spacer |
OsteoRemedies, LLC |
| K101047 |
04/14/2010 |
PTA-DUO PTA BALLOON CATHETER |
HOTSPUR TECHNOLOGIES |
| K050998 |
04/20/2005 |
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 |
CONFLUENT SURGICAL,INC |
| K061183 |
04/28/2006 |
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 |
CONFLUENT SURGICAL,INC |
| K142300 |
08/18/2014 |
Arrow GPSCath Balloon Dialation Catheter (150 cm) |
HOTSPUR TECHNOLOGIES, INC., |
|
|
