FDA 510(k) Applications Submitted by DEEP PAL
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K080144 |
01/22/2008 |
MANDREL GUIDEWIRES OR M-WIRES |
LAKE REGION MFG., INC. |
K170312 |
02/01/2017 |
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
K120589 |
02/28/2012 |
MILAGRO INTERFERENCE SCREWS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
K160713 |
03/15/2016 |
Stealth-Midas System |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
K201012 |
04/17/2020 |
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
K141455 |
06/02/2014 |
EASYDRILL AUTOSTOP CRANIAL PERFORATOR |
MICROMAR IND. COM. LTD. |
K111631 |
06/13/2011 |
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
K081708 |
06/17/2008 |
TAXI ENDOSCOPIC GUIDEWIRE |
LAKE REGION MFG., INC. |
K112249 |
08/05/2011 |
HEALIX KNOTLESS(TM) ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
K112417 |
08/23/2011 |
VARIOUS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
K102443 |
08/26/2010 |
INTRAFIX TIBIAL SHEATH |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
K182529 |
09/14/2018 |
Xperius Ultrasound System |
Philips Ultrasound, Inc. |
K082922 |
10/01/2008 |
FREEWAY AND RAILRUNNER GUIDEWIRES |
LAKE REGION MFG., INC. |
K143175 |
11/04/2014 |
AEx Generator; PlasmaBlade T |
MEDTRONIC ADVANCED ENERGY |
K163182 |
11/14/2016 |
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories |
Medtronic Powered Surgical Solutions |
K113534 |
11/30/2011 |
HEALIX KNOTLESS ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
K163565 |
12/19/2016 |
MR8 Drill System |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
K103831 |
12/30/2010 |
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
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