FDA 510(k) Applications Submitted by Rebecca S. Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010343 |
02/05/2001 |
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 |
BUCK MEDICAL RESEARCH |
| K992963 |
09/02/1999 |
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 |
INTERNATIONAL ISOTOPES, INC. |
| K250752 |
03/12/2025 |
AURORA« Surgiscope« System (ASX15/60); AURORA« Surgiscope« System (ASX15/80) |
Integra LifeSciences Corporation |
| K182399 |
09/04/2018 |
Park Blade Septostomy Catheter |
Cook Incorporated |
| K171602 |
06/01/2017 |
Williams Cystoscopic Injection Needle |
Cook Incorporated |
| K172527 |
08/21/2017 |
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe |
Cook Incorporated |
| K180216 |
01/25/2018 |
Seidmon Antegrade AQ Stent Set |
Cook Incorporated |
| K170059 |
01/06/2017 |
Spectranetics Turbo-Elite Laser Atherectomy Catheters |
Spectranetics, Inc. |
| K182242 |
08/20/2018 |
VO200 û NeurOs Cerebral Oximetry System |
Mespere LifeSciences Inc. |
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