Barrier, Animal Source, Intraoral
Regulation 872.3930
3510(k)s in 12 months (57 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in NPL
| Company | 510(k)s | Recalls |
|---|---|---|
| Collagen Matrix, Inc. | 10 | 7 |
| Geistlich Pharma AG | 9 | 0 |
| Kensey Nash Corp. | 3 | 3 |
| Ed. Geistlich Soehne AG Fuer Chemische Industrie | 5 | 0 |
| Cook Biotech Incorporated | 3 | 0 |
| Datum Dental, Ltd. | 3 | 0 |
| Biom'Up Sas | 1 | 1 |
| Kerecis | 2 | 0 |
| Aroa Biosurgery , Ltd. | 1 | 0 |
| Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2006 | K053260 | OSSIX -PLUS Colbar Lifescience , Ltd. | NPL |
| Aug 9, 2005 | K050446 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL |
| Nov 15, 2004 | K042197 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL |
| Jan 24, 2003 | K012423 | MUCOGRAFT Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL |
| Jun 10, 2002 | K010952 | SURGISIS GUIDED TISSUE REGENERATION MATRIX Cook Biotech, Inc. | NPL |
| Aug 7, 2001 | K011695 | COLLAGEN DENTAL MEMBRANE Collagen Matrix, Inc. | NPL |
| Jan 8, 2001 | K003339 | COLLAGEN PERIODONTAL MEMBRANE Collagen Matrix, Inc. | NPL |
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