Geistlich Pharma AG
WOLHUSEN Luzern, CH
GEISTLICH PHARMA AG appears in FDA device records in WOLHUSEN Luzern, CH. FDA records list 43 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 43 510(k) clearances for Geistlich Pharma AG between 1983 and 2026. The busiest year on record is 2025, with 7. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1992 | 1 |
| 1995 | 3 |
| 1997 | 1 |
| 1998 | 3 |
| 2000 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 7 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260364 | Device 300419 Strip | MQV | Substantially Equivalent | |
| K260532 | Derma-Gide | KGN | Substantially Equivalent | |
| K251323 | Device 104 Particulate | KGN | Substantially Equivalent | |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | NPL | Substantially Equivalent | |
| 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 | NPL | Substantially Equivalent | |
| K251556 | Device 300423 Granules | MQV | Substantially Equivalent | |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | NPM | Substantially Equivalent | |
| K251613 | SwissGraft X | NPM | Substantially Equivalent | |
| K250833 | SwissMembrane X; SwissMembrane X Socket | NPL | Substantially Equivalent | |
| K242510 | Geistlich Bio-Flow® | NPM | Substantially Equivalent | |
| K241802 | Device 300397 Putty | MQV | Substantially Equivalent | |
| K240661 | Geistlich Bio-Oss® | NPM | Substantially Equivalent | |
| K213607 | Geistlich Wound Matrix PLUS | KGN | Substantially Equivalent | |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | NPL | Substantially Equivalent | |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | FTM | Substantially Equivalent | |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | NPL | Substantially Equivalent | |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal | NPL | Substantially Equivalent | |
| K190754 | Orthoss(R) | MQV | Substantially Equivalent | |
| K182838 | Geistlich Derma-Gide | KGN | Substantially Equivalent | |
| K171050 | Geistlich Fibro-Gide | NPL | Substantially Equivalent | |
| K171842 | Geistlich Wound Matrix | KGN | Substantially Equivalent | |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | NPL | Substantially Equivalent | |
| K140518 | GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER | NPL | Substantially Equivalent | |
| K122894 | GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC | NPM | Substantially Equivalent | |
| K120601 | GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O | NPM | Substantially Equivalent | |
| K112572 | GEISTLICH COMBI-KIT COLLEGEN | NPM | Substantially Equivalent | |
| K112575 | GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO | NPM | Substantially Equivalent | |
| K033815 | BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN | NPM | Substantially Equivalent | |
| K014289 | ORTHOSS RESORBABLE BONE VOID FILLER | LYC | Substantially Equivalent | |
| K970569 | BIO-BLOCKS | LYC | Substantially Equivalent | |
| K974399 | BIO-OSS COLLAGEN | LYC | Substantially Equivalent | |
| K970321 | BIO-OSS ANORGANIC BOVINE BONE | LYC | Substantially Equivalent | |
| K972817 | RESOR-PIN RESORBABLE MEMBRANE PIN | LYC | Substantially Equivalent | |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | NPK | Substantially Equivalent | |
| K952619 | BIO-OSS CERAMIC | LYC | Substantially Equivalent | |
| K952618 | BIO-OSS | LYC | Substantially Equivalent | |
| K952617 | BIO-OSS | LYC | Substantially Equivalent | |
| K920508 | BIO-OSS BLOCKS | LYC | Substantially Equivalent | |
| K874943 | SONAR-AID(R) ULTRASOUND STANDOFF PAD | ITX | Substantially Equivalent | |
| K873763 | BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE | LYC | Substantially Equivalent | |
| K871773 | BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT | LYC | Substantially Equivalent for Some Indications | |
| K850819 | GELIPERM ABSORBIND GRANULATED GEL | FRO | Substantially Equivalent | |
| K823225 | GELIPERM GRANULES | FRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614442 | 3000303710 | GEISTLICH PHARMA AG | BAHNHOFSTRASSE 40, WOLHUSEN Luzern CH-6110 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NPLBarrier, Animal Source, Intraoral
- NPKBarrier, Synthetic, Intraoral
- NPMBone Grafting Material, Animal Source
- LYCBone Grafting Material, Synthetic
- FRODressing, Wound, Drug
- MQVFiller, Bone Void, Calcium Compound
- FTMMesh, Surgical
- OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- ITXTransducer, Ultrasonic, Diagnostic
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain