FDA 510(k) Applications Submitted by Nora York
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K173860 |
12/20/2017 |
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System |
Volcano Corporation |
| K090632 |
03/09/2009 |
COMPEX REHAB |
CHATTANOOGA GROUP |
| K021740 |
05/28/2002 |
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED |
DJ ORTHOPEDICS, LLC |
| K993203 |
09/24/1999 |
ACON ONE STEP PREGNANCY TEST STRIP (URINE) |
ACON LABORATORIES, INC. |
| K993317 |
10/04/1999 |
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
| K993483 |
10/14/1999 |
ACON ONE STEP HOME PREGNANCY TEST STRIP |
ACON LABORATORIES, INC. |
| K003557 |
11/17/2000 |
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
| K220413 |
02/14/2022 |
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System |
Canary Medical USA LLC |
| DEN200064 |
10/19/2020 |
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System |
Canary Medical, Inc. |
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