# FDA device clearances in Germany: 223 since Nov 2024

Updated October 30, 2026.

FDA made 223 device decisions for applicants in Germany from November 20, 2024 to October 30, 2026: 223 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 120 applicants. The newest, K262066 on October 30, 2026, is Pleiades Device from My123Baby Medical Limited Dba Boost Fertility.

## The full list

FDA device clearances for applicants in Germany: 223 rows for $11.15, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 11 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/country/germany

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 223
- 510(k) and De Novo: 223
- PMA: 0
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 223, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | K262066 | Pleiades Device | My123Baby Medical Limited Dba Boost Fertility | Germany | Substantially Equivalent | 510(k) traditional | MQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262066) |
| October 29, 2026 | K260356 | EndoColibri | Koehrer Medical Engineering GmbH | Germany | Substantially Equivalent | 510(k) traditional | NYL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260356) |
| October 27, 2026 | K262229 | DORO® Headrest System for AVA | Black Forest Medical GmbH | Germany | Substantially Equivalent | 510(k) traditional | HBL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262229) |
| October 23, 2026 | K260302 | B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC | B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) | Germany | Substantially Equivalent | 510(k) traditional | SJQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260302) |
| October 22, 2026 | K262126 | Cerclage Wires;K-wires;Steinmann Pins | MK Medical GmbH | Germany | Substantially Equivalent | 510(k) traditional | HTY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262126) |
| October 15, 2026 | K261361 | TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque... | Carl Zeiss Meditec, AG | Germany | Substantially Equivalent | 510(k) traditional | LFL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261361) |
| October 14, 2026 | K260581 | KARL STORZ Flexible Video Neuro-Endoscope | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | GWG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260581) |
| October 5, 2026 | K261655 | RT Elements (4.6) | Brainlab SE | Germany | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261655) |
| October 2, 2026 | K260487 | stentFIX System Set (100.50n) | Ovesco Endoscopy AG | Germany | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260487) |
| September 30, 2026 | K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | Germany | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262257) |
| September 30, 2026 | K262038 | danumed StomaMeter | Danumed Medizintechnik GmbH | Germany | Substantially Equivalent | 510(k) traditional | KNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262038) |
| September 29, 2026 | K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | Germany | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263048) |
| September 29, 2026 | K260031 | THERMEO® I MSI | Pro3Dure Medical GmbH | Germany | Substantially Equivalent | 510(k) traditional | MQC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260031) |
| September 25, 2026 | K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver... | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | HIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254252) |
| September 24, 2026 | K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | Germany | Substantially Equivalent | 510(k) special | GWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263010) |
| September 24, 2026 | K262168 | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | Germany | Substantially Equivalent | 510(k) traditional | PEN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262168) |
| September 24, 2026 | K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | Germany | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260949) |
| September 22, 2026 | K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | Germany | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254168) |
| September 21, 2026 | K262547 | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | Germany | Substantially Equivalent | 510(k) traditional | OWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262547) |
| September 18, 2026 | K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | HIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261102) |
| September 17, 2026 | K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | Germany | Substantially Equivalent | 510(k) traditional | PEM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262073) |
| September 15, 2026 | K260446 | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | Germany | Substantially Equivalent | 510(k) traditional | HAE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260446) |
| September 15, 2026 | K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation... | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | EOB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254299) |
| September 14, 2026 | K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | Germany | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253481) |
| September 11, 2026 | K261019 | ANTERION | Heidelberg Engineering GmbH | Germany | Substantially Equivalent | 510(k) traditional | OBO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261019) |
| September 10, 2026 | K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | Germany | Substantially Equivalent | 510(k) traditional | PIF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260110) |
| September 3, 2026 | K262243 | Profisil Free | Kettenbach GmbH & Co. KG | Germany | Substantially Equivalent | 510(k) traditional | LBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262243) |
| September 1, 2026 | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260884) |
| August 26, 2026 | K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | HRX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254103) |
| August 19, 2026 | K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | HIF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260209) |
| August 11, 2026 | K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | Germany | Substantially Equivalent | 510(k) traditional | DAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253985) |
| August 7, 2026 | K252571 | mdprostate | Mediaire GmbH | Germany | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252571) |
| August 6, 2026 | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | Germany | Substantially Equivalent | 510(k) traditional | PAM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254194) |
| July 31, 2026 | K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | Germany | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260852) |
| July 22, 2026 | K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | Germany | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261179) |
| July 20, 2026 | K261573 | ENDOSCOPE HOLDER (182214) | Aktormed GmbH | Germany | Substantially Equivalent | 510(k) traditional | QZB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261573) |
| July 17, 2026 | K260694 | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | Germany | Substantially Equivalent | 510(k) traditional | NFJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260694) |
| July 16, 2026 | K261706 | Endomat Select (UP220) | Karl Storz Se & Co. KG | Germany | Substantially Equivalent | 510(k) traditional | HIG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261706) |
| July 15, 2026 | K260338 | ThinkSono Guidance | ThinkSono GmbH | Germany | Substantially Equivalent | 510(k) traditional | QJU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260338) |
| July 10, 2026 | K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | Germany | Substantially Equivalent | 510(k) traditional | MQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261031) |
| July 8, 2026 | K260278 | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | Germany | Substantially Equivalent | 510(k) traditional | DWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260278) |
| July 6, 2026 | K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | Germany | Substantially Equivalent | 510(k) traditional | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261009) |
| July 1, 2026 | K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | Germany | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261054) |
| June 30, 2026 | K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | Germany | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260576) |
| June 26, 2026 | K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | Germany | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253921) |
| June 16, 2026 | K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | Germany | Substantially Equivalent | 510(k) traditional | DXN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260693) |
| June 16, 2026 | K253264 | myAblation Guide (VC10A) | Siemens Healthcare GmbH | Germany | Substantially Equivalent | 510(k) traditional | QTZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253264) |
| June 15, 2026 | K253690 | LungMaps | Siemens Healthineers AG | Germany | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253690) |
| June 10, 2026 | K260614 | Tinnitus Therapy | Sivantos GmbH | Germany | Substantially Equivalent | 510(k) special | KLW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260614) |
| June 9, 2026 | K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | Germany | Substantially Equivalent | 510(k) special | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261806) |
| June 4, 2026 | K253004 | LUNA 3D | Lap GmbH Laser Applikationen | Germany | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253004) |
| June 3, 2026 | K252800 | KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | OCZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252800) |
| June 2, 2026 | K261540 | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | Germany | Substantially Equivalent | 510(k) special | PGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261540) |
| May 29, 2026 | K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH | Germany | Substantially Equivalent | 510(k) traditional | DQA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252821) |
| May 22, 2026 | K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | Germany | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260560) |
| May 21, 2026 | K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO)... | Olympus Winter & Ibe GmbH | Germany | Substantially Equivalent | 510(k) traditional | FAJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260649) |
| May 21, 2026 | K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | Germany | Substantially Equivalent | 510(k) traditional | EIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253191) |
| May 21, 2026 | K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | Germany | Substantially Equivalent | 510(k) traditional | BSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252746) |
| May 19, 2026 | K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | Germany | Substantially Equivalent | 510(k) traditional | OAT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260268) |
| May 14, 2026 | K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | Germany | Substantially Equivalent | 510(k) special | KGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261224) |
| May 7, 2026 | K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | Germany | Substantially Equivalent | 510(k) traditional | OBO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253837) |
| May 7, 2026 | K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | Germany | Substantially Equivalent | 510(k) traditional | CBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253647) |
| May 1, 2026 | K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor... | Philips Medizin Systeme | Germany | Substantially Equivalent | 510(k) traditional | DQA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253887) |
| May 1, 2026 | K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | Germany | Substantially Equivalent | 510(k) traditional | LBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252073) |
| April 30, 2026 | K261067 | BEE PLIF Cage | NGMedical GmbH | Germany | Substantially Equivalent | 510(k) special | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261067) |
| April 30, 2026 | K253436 | c-med0 alpha | Cosinuss GmbH | Germany | Substantially Equivalent | 510(k) traditional | MWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253436) |
| April 29, 2026 | K261094 | YellowStar | Asclepion Laser Technologies GmbH | Germany | Substantially Equivalent | 510(k) special | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261094) |
| April 27, 2026 | K261357 | Grandio disc multicolor | Voco GmbH | Germany | Substantially Equivalent | 510(k) traditional | EBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261357) |
| April 24, 2026 | K252451 | EPORE® XO cup system | Implantcast GmbH | Germany | Substantially Equivalent | 510(k) traditional | OQI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252451) |
| April 24, 2026 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | Germany | Substantially Equivalent | 510(k) traditional | JKR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252431) |
| April 22, 2026 | K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | Germany | Substantially Equivalent | 510(k) traditional | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253230) |
| April 16, 2026 | K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | Germany | Substantially Equivalent | 510(k) traditional | FGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251658) |
| April 15, 2026 | K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | Germany | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252258) |
| April 10, 2026 | K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | Germany | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253689) |
| April 10, 2026 | K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | Germany | Substantially Equivalent | 510(k) traditional | QKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252548) |
| March 30, 2026 | K260037 | implantcast Packaging System Update | Implantcast GmbH | Germany | Substantially Equivalent | 510(k) traditional | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260037) |
| March 30, 2026 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | Germany | Substantially Equivalent | 510(k) traditional | MSX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253654) |
| March 24, 2026 | K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | Germany | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254253) |
| March 20, 2026 | K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | Germany | Substantially Equivalent | 510(k) traditional | EMA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252606) |
| March 18, 2026 | K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | Germany | Substantially Equivalent | 510(k) traditional | HJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253834) |
| March 13, 2026 | K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | Germany | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251999) |
| March 13, 2026 | K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | Germany | Substantially Equivalent | 510(k) traditional | MXK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251848) |
| March 12, 2026 | K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | Germany | Substantially Equivalent | 510(k) special | FWP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254233) |
| March 12, 2026 | K252401 | implaFit® short stems | Implantcast GmbH | Germany | Substantially Equivalent | 510(k) traditional | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252401) |
| March 9, 2026 | K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | Germany | Substantially Equivalent | 510(k) traditional | PCH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254032) |
| March 6, 2026 | K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | Germany | Substantially Equivalent | 510(k) traditional | HBB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253772) |
| March 6, 2026 | K253262 | EmeryGlide™ (EG18008901) | Nano4imaging GmbH | Germany | Substantially Equivalent | 510(k) special | DQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253262) |
| March 2, 2026 | K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | EWY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260003) |
| February 26, 2026 | K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | OWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254242) |
| February 23, 2026 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Substantially Equivalent | 510(k) traditional | KLE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251587) |
| February 19, 2026 | K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | Germany | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254148) |
| February 19, 2026 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4... | Stryker Leibinger GmbH & Co KG | Germany | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253623) |
| February 13, 2026 | K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | Germany | Substantially Equivalent | 510(k) traditional | FMZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251619) |
| February 12, 2026 | K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | OWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253972) |
| February 11, 2026 | K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | Germany | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251813) |
| February 6, 2026 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | Germany | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252871) |
| February 6, 2026 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX... | Philips Medizin Systeme Boeblingen GmbH | Germany | Substantially Equivalent | 510(k) traditional | MHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252726) |
| January 22, 2026 | K253057 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | Germany | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253057) |
| January 22, 2026 | K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | Germany | Substantially Equivalent | 510(k) traditional | FLE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252307) |
| January 16, 2026 | K253408 | CoolTone | Zimmer Medizinsysteme GmbH | Germany | Substantially Equivalent | 510(k) traditional | NGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253408) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Karl Storz SE & CO. KG | 19 | October 14, 2026 |
| Siemens Healthcare GmbH | 10 | June 16, 2026 |
| Philips Medizin Systeme Böblingen GmbH | 8 | May 29, 2026 |
| Brainlab AG | 8 | October 16, 2025 |
| QIAGEN GmbH | 7 | September 24, 2026 |
| Siemens Healthineers AG | 6 | September 29, 2026 |
| Erbe Elektromedizin GmbH | 6 | June 9, 2026 |
| Stryker Leibinger GmbH & Co KG | 5 | July 1, 2026 |
| Voco GmbH | 5 | May 1, 2026 |
| PAJUNK GmbH Medizintechnologie | 5 | July 1, 2025 |
| Ovesco Endoscopy AG | 4 | October 2, 2026 |
| Heidelberg Engineering GmbH | 4 | September 11, 2026 |
| Implantcast GmbH | 4 | April 24, 2026 |
| Ziehm Imaging GmbH | 4 | March 17, 2025 |
| Carl Zeiss Meditec, AG | 3 | October 15, 2026 |
| Brainlab SE | 3 | October 5, 2026 |
| Waldemar Link GmbH & Co. KG | 3 | July 6, 2026 |
| Mag & More GmbH | 3 | May 22, 2026 |
| Danumed Medizintechnik GmbH | 2 | September 30, 2026 |
| Kettenbach GmbH & Co. KG | 2 | September 3, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 39 | October 5, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 24 | October 29, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 23 | October 27, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 22 | October 2, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 20 | October 22, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 20 | July 8, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 17 | September 17, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 11 | September 24, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 10 | October 23, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 8 | October 30, 2026 |
| Unknown | 7 | October 15, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 7 | September 11, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 5 | September 15, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 3 | February 13, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 3 | January 16, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 2 | August 11, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 1 | April 24, 2026 |
| [Clinical Toxicology](https://specstream.ai/data/fda-clearances/panel/clinical-toxicology) | 1 | September 11, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 199 | October 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 23 | September 24, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | July 14, 2025 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).