Company ยท DE
Hager& Meisinger GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2025 | K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) Hager& Meisinger GmbH, DE | DZL |
| Oct 17, 2024 | K240321 | MP Pin flat without thread (36BMP000020/MP20) Hager& Meisinger GmbH, DE | DZL |
| Oct 8, 2021 | K201210 | The Micro Screw System, Micro Screw System Basic Hager& Meisinger GmbH, DE | DZL |
| Aug 9, 2018 | K173819 | MyPlant II Implant System Hager& Meisinger GmbH, DE | DZE |
| May 10, 2018 | K180360 | OKTAGON Implant System Hager& Meisinger GmbH, DE | DZE |
| May 24, 2017 | K170287 | Dental Implants OKTAGON Bone Level Tapered Design Hager& Meisinger GmbH, DE | DZE |
| Feb 24, 2017 | K162073 | Dental Implants OKTAGON Tissue Level and Bone Level Hager& Meisinger GmbH, DE | DZE |
| Nov 21, 2016 | K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC Hager& Meisinger GmbH, DE | NHA |
| Aug 31, 2015 | K143539 | Dental Implant OKTAGON Bone Level Hager& Meisinger GmbH, DE | DZE |
| Jul 7, 2014 | K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE Hager& Meisinger GmbH, DE | NHA |
| Jun 13, 2014 | K122807 | DENTAL IMPLANT SYSTEM Hager& Meisinger GmbH | DZE |
| Feb 14, 2014 | K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL Hager& Meisinger GmbH, DE | DZL |
| Aug 13, 2013 | K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT Hager& Meisinger GmbH, DE | DZL |
| Apr 16, 2007 | K062130 | MEISINGER BENEX, MODEL BE001 Hager& Meisinger GmbH | EMG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2020 | Hager & Meisinger Gmbh SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended Terminated |
EJL | None listed |
| Nov 7, 2018 | Hager & Meisinger Gmbh Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm: Open, Classified |
EJL | None listed |