Company
Geistlich Pharma North America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NPM | Bone Grafting Material, Animal Source | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2020 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126 Terminated |
NPM | K120601 |
| Oct 19, 2020 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116 Terminated |
NPM | K120601 |
| Oct 19, 2020 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115 Terminated |
NPM | K120601 |
| Aug 2, 2019 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Terminated |
NPM | K120601 |
| Aug 2, 2019 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmentation or reconstructive treatment of the alveolar ri Terminated |
NPM | K120601 |
| Aug 2, 2019 | Geistlich Pharma North America, Inc. Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar r Terminated |
NPM | K120601 |