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Data / Medical devices / Switzerland / Geistlich Pharma AG

Geistlich Pharma AG: FDA-registered device maker in WOLHUSEN Luzern, Switzerland, 18 510(k) clearances

Geistlich Pharma AG is registered with the FDA (registration 9614442) in WOLHUSEN Luzern, Switzerland. It lists 6 device types. The FDA files 18 510(k) clearances under its listings, the newest dated June 2, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Geistlich Pharma AG
FDA registration number
9614442
FEI number
3000303710
Address
Bahnhofstrasse 40, WOLHUSEN Luzern, Switzerland, CH-6110
Owner or operator
Geistlich Pharma AG (9011644)
Roles
Complaint file establishment, Manufacturer
First device listed
September 1, 2014
Registered through
2026
Brand names listed
Cirrus Putty, Combi-Kit Collagen, Derma-Gide®, Geistlich Bio-Gide®, Geistlich Bio-Gide® Compressed, Geistlich Bio-Gide® Forte, Geistlich Bio-Gide® Perio, Geistlich Bio-Gide® Shape and more

Devices it lists

DeviceProduct codeClassRoleSource
Barrier, Animal Source, IntraoralNPL2Complaint file establishment, Manufactureraccessdata.fda.gov
Bone Grafting Material, Animal SourceNPM2Complaint file establishment, Manufactureraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Complaint file establishment, Manufactureraccessdata.fda.gov
Mesh, SurgicalFTM2Complaint file establishment, Manufactureraccessdata.fda.gov
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonOWW2Complaint file establishment, Manufactureraccessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)KGNUComplaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 2, 2026K260364Device 300419 StripMQVSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
March 19, 2026K260532Derma-GideKGNSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
January 22, 2026K251323Device 104 ParticulateKGNSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
November 25, 2025K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPLSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
August 14, 2025K251062Geistlich 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 PackNPLSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
July 17, 2025K251556Device 300423 GranulesMQVSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
July 11, 2025K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPMSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
June 26, 2025K251613SwissGraft XNPMSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
April 15, 2025K250833SwissMembrane X; SwissMembrane X SocketNPLSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
March 7, 2025K242510Geistlich Bio-Flow®NPMSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
November 8, 2024K241802Device 300397 PuttyMQVSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
July 12, 2024K240661Geistlich Bio-Oss®NPMSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
April 28, 2022K213607Geistlich Wound Matrix PLUSKGNSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
April 5, 2022K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi PackNPLSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
July 14, 2021K203496Nexo-Gide Bilayer Collagen MembraneFTMSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
March 3, 2021K210280Geistlich Mucograft®, Geistlich Mucograft® SealNPLSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
November 8, 2018K182838Geistlich Derma-GideKGNSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov
February 15, 2013K122894GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLICNPMSubstantially EquivalentGeistlich Pharma AGaccessdata.fda.gov

Compare with other makers

Updated June 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.