FDA 510(k) Applications Submitted by GABRIELE G NIEDERAUER, PH.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K072470 |
09/04/2007 |
BIOELAST 5-0 SUTURE, MODEL 500100 |
ENTRIGUE SURGICAL, INC. |
| K040047 |
01/12/2004 |
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE |
OSTEOBIOLOGICS, INC. |
| K130354 |
02/12/2013 |
MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) |
ENTRIGUE SURGICAL, INC. |
| K051656 |
06/21/2005 |
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM |
OSTEOBIOLOGICS, INC. |
| K032673 |
08/29/2003 |
IMMIX PLASTIFILM |
OSTEOBIOLOGICS, INC. |
| K082750 |
09/19/2008 |
ENTACT SEPTAL STAPLER, MODEL 610-00100 |
ENTRIGUE SURGICAL, INC. |
| K073226 |
11/15/2007 |
CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
C2M MEDICAL, INC. |
| K043172 |
11/16/2004 |
TRUGRAFT BGS SYRINGE, MODEL 600-041 |
OSTEOBIOLOGICS, INC. |
| K024199 |
12/20/2002 |
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP |
OSTEOBIOLOGICS, INC. |
| K121351 |
05/04/2012 |
SINUS DILATION SYSTEM |
ENTRIGUE SURGICAL, INC. |
| K041382 |
05/25/2004 |
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE |
OSTEOBIOLOGICS, INC. |
| K033707 |
11/26/2003 |
POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX |
OSTEOBIOLOGICS, INC. |
| DEN190038 |
08/15/2019 |
Surfacer Inside-Out Access Catheter System |
Bluegrass Vascular Technologies, Inc. |
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