# Geistlich Pharma AG

- Location (FDA's records): Washington, DC
- FDA decisions: 43 (1983–2026): 43 510(k) clearances
- Names in FDA's records: Geistlich Pharma AG (27); Geistlich-Pharma (16)
- Product codes: LYC (11), NPM (9), NPL (9), KGN (5), MQV (4), FRO (2), FTM (1), NPK (1), ITX (1)
- 510(k) review time since 2016: median 130 days, against 132 for FDA's reviews in the same codes and years (8 of 20 faster)
- Predicates its devices cite: 68 (45 its own); citations of its devices by later devices: 112 (45 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ed. Geistlich Soehne AG Fuer Chemische Industrie: 13 (https://510kreport.com/company/ed-geistlich-soehne-ag-fuer-chemische-industrie)
- Ed. Geistlich Soehne AG Fur Chemische Industrie: 5 (https://510kreport.com/company/ed-geistlich-soehne-ag-fur-chemische-industrie)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Acell, Inc.: 1 (https://510kreport.com/company/acell)
- Miromatrix Medical, Inc.: 1 (https://510kreport.com/company/miromatrix-medical)

## Firms that cite its devices most
- Collagen Matrix, Inc.: 11 (https://510kreport.com/company/collagen-matrix)
- Ed. Geistlich Soehne AG Fuer Chemische Industrie: 6 (https://510kreport.com/company/ed-geistlich-soehne-ag-fuer-chemische-industrie)
- Odontit S.A.: 4 (https://510kreport.com/company/odontit)
- Luitpold Pharmaceuticals, Inc.: 4 (https://510kreport.com/company/luitpold-pharmaceuticals)
- Nibec Co., Ltd.: 4 (https://510kreport.com/company/nibec)
- Purgo Biologics, Inc.: 2 (https://510kreport.com/company/purgo-biologics)
- Ed. Geistlich Soehne AG Fur Chemische Industrie: 2 (https://510kreport.com/company/ed-geistlich-soehne-ag-fur-chemische-industrie)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)

## Its most-cited devices
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen (2004), cited by 18
- K970321: Bio-Oss Anorganic Bovine Bone (1998), cited by 12
- K974399: Bio-Oss Collagen (1998), cited by 12
- K960724: Bio-Gide Resorbable Bilayer Membrane (1997), cited by 11
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic (2013), cited by 10
- K952617: Bio-Oss (1995), cited by 6

## Recent decisions
- K260364: Device 300419 Strip (Jun 2, 2026)
- K260532: Derma-Gide (Mar 19, 2026)
- K251323: Device 104 Particulate (Jan 22, 2026)
- K252253: Geistlich Mucograft® /Geistlich Mucograft®  Seal; Geistlich Fibro-Gide® (Nov 25, 2025)
- K251062: Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack (Aug 14, 2025)
- K251556: Device 300423 Granules (Jul 17, 2025)
- K251786: Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (Jul 11, 2025)
- K251613: SwissGraft X (Jun 26, 2025)

Source page: https://510kreport.com/company/geistlich-pharma