Data / FDA device clearances / Switzerland
FDA device clearances in Switzerland: 126 since Nov 2024
The full list. FDA device clearances for applicants in Switzerland: 126 rows for $6.30, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 4 rows a month. The new rows come each week by email, $19 a month.
Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.
For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/country/switzerland, and every list with its row count and price is at https://specstream.ai/data/lists.json.
Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).
FDA made 126 device decisions for applicants in Switzerland from November 13, 2024 to October 30, 2026: 126 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 50 applicants. The newest, K260360 on October 30, 2026, is AesyBite Active from Aesyra SA.
The request: Every new FDA device clearance or approval for a company in Switzerland, with its address, the device and the product code. $10 of credit on sign-up, no card.
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.
- 126Decisions
- 126510(k) and De Novo
- 0PMA
- October 30, 2026Latest decision
Newest decisions
The newest 100 of 126, 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 | K260360 | AesyBite Active | Aesyra SA | Switzerland | Substantially Equivalent | 510(k) traditional | HCC | accessdata.fda.gov |
| October 29, 2026 | K263582 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | Switzerland | Substantially Equivalent | 510(k) special | KYJ | accessdata.fda.gov |
| October 23, 2026 | K262080 | OTOPLAN | Cascination AG | Switzerland | Substantially Equivalent | 510(k) traditional | QQE | accessdata.fda.gov |
| October 8, 2026 | K263680 | One Coat Bond; One Coat Bond SL | Dent4You AG | Switzerland | Substantially Equivalent | 510(k) traditional | KLE | accessdata.fda.gov |
| September 29, 2026 | K261225 | CAS-One IR | Cascination AG | Switzerland | Substantially Equivalent | 510(k) traditional | JAK | accessdata.fda.gov |
| September 22, 2026 | K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | IOR | accessdata.fda.gov |
| September 17, 2026 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | LZO | accessdata.fda.gov |
| September 15, 2026 | K262057 | GMK Extension | Medacta International SA | Switzerland | Substantially Equivalent | 510(k) traditional | JWH | accessdata.fda.gov |
| September 11, 2026 | K260115 | DRIM-Nail System | 41Medical AG | Switzerland | Substantially Equivalent | 510(k) traditional | accessdata.fda.gov | |
| September 5, 2026 | K254135 | LipoSurg ARTIST | Nouvag AG | Switzerland | Substantially Equivalent | 510(k) traditional | QPB | accessdata.fda.gov |
| August 28, 2026 | K253630 | Mpact 3D Metal Foam | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | LPH | accessdata.fda.gov |
| August 20, 2026 | K261049 | SCALA® TL | Spineart SA | Switzerland | Substantially Equivalent | 510(k) traditional | MAX | accessdata.fda.gov |
| August 14, 2026 | K262639 | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | Switzerland | Substantially Equivalent | 510(k) traditional | QLQ | accessdata.fda.gov |
| August 14, 2026 | K253562 | medilogFD | Schiller AG | Switzerland | Substantially Equivalent | 510(k) traditional | MWJ | accessdata.fda.gov |
| August 11, 2026 | K261398 | Dexter L6 System | Distalmotion SA | Switzerland | Substantially Equivalent | 510(k) traditional | SDD | accessdata.fda.gov |
| July 29, 2026 | K261205 | SPINEART Navigation Instrument System | Spineart SA | Switzerland | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| July 20, 2026 | K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | Switzerland | Substantially Equivalent | 510(k) special | QIH | accessdata.fda.gov |
| June 29, 2026 | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | HSB | accessdata.fda.gov |
| June 26, 2026 | K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| June 20, 2026 | K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | Switzerland | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| June 11, 2026 | K260653 | Dexter L6 System | Distalmotion SA | Switzerland | Substantially Equivalent | 510(k) traditional | SDD | accessdata.fda.gov |
| June 10, 2026 | K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | Switzerland | Substantially Equivalent | 510(k) traditional | PHX | accessdata.fda.gov |
| June 5, 2026 | K260761 | APTUS Clavicle System 2.8 | Medartis AG | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| June 3, 2026 | K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) | Institut Straumann AG | Switzerland | Substantially Equivalent | 510(k) traditional | KCT | accessdata.fda.gov |
| June 3, 2026 | K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | Switzerland | Substantially Equivalent | 510(k) traditional | NHA | accessdata.fda.gov |
| June 2, 2026 | K260364 | Device 300419 Strip | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) traditional | MQV | accessdata.fda.gov |
| May 26, 2026 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | Switzerland | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| May 20, 2026 | K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | Switzerland | Substantially Equivalent | 510(k) traditional | LIT | accessdata.fda.gov |
| May 7, 2026 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | Switzerland | Substantially Equivalent | 510(k) traditional | NHA | accessdata.fda.gov |
| May 5, 2026 | K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | OVD | accessdata.fda.gov |
| May 1, 2026 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | Switzerland | Substantially Equivalent | 510(k) traditional | NKB | accessdata.fda.gov |
| April 28, 2026 | K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | NKB | accessdata.fda.gov |
| April 24, 2026 | K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| April 17, 2026 | K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | Switzerland | Substantially Equivalent | 510(k) special | HWC | accessdata.fda.gov |
| April 17, 2026 | K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | Switzerland | Substantially Equivalent | 510(k) traditional | KPI | accessdata.fda.gov |
| April 10, 2026 | K252757 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | Switzerland | Substantially Equivalent | 510(k) special | OPP | accessdata.fda.gov |
| April 9, 2026 | K254158 | SPINEART Navigation Instrument System | Spineart SA | Switzerland | Substantially Equivalent | 510(k) special | OLO | accessdata.fda.gov |
| March 27, 2026 | K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | MAI | accessdata.fda.gov |
| March 27, 2026 | K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | Switzerland | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| March 19, 2026 | K260532 | Derma-Gide | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) special | KGN | accessdata.fda.gov |
| March 16, 2026 | K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| March 10, 2026 | K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | Synthes GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| March 10, 2026 | K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | Switzerland | Substantially Equivalent | 510(k) traditional | DZE | accessdata.fda.gov |
| March 9, 2026 | K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| March 2, 2026 | K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| February 26, 2026 | K260254 | Enbio PRO | Enbio Group AG | Switzerland | Substantially Equivalent | 510(k) traditional | FLE | accessdata.fda.gov |
| February 26, 2026 | K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | MBH | accessdata.fda.gov |
| February 3, 2026 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | HSB | accessdata.fda.gov |
| February 3, 2026 | K250644 | MSS - Monobloc stem | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | PHX | accessdata.fda.gov |
| January 28, 2026 | K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | Switzerland | Substantially Equivalent | 510(k) special | DRT | accessdata.fda.gov |
| January 28, 2026 | K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | Switzerland | Substantially Equivalent | 510(k) traditional | ELC | accessdata.fda.gov |
| January 28, 2026 | K251043 | Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | LPH | accessdata.fda.gov |
| January 22, 2026 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | Switzerland | Substantially Equivalent | 510(k) traditional | NHA | accessdata.fda.gov |
| January 22, 2026 | K251323 | Device 104 Particulate | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) traditional | KGN | accessdata.fda.gov |
| January 9, 2026 | K252847 | NextAR Hip Platform | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | SBF | accessdata.fda.gov |
| January 2, 2026 | K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG | Switzerland | Substantially Equivalent | 510(k) special | OWX | accessdata.fda.gov |
| December 19, 2025 | K253202 | Hoffmann LRF System | Stryker GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | KTT | accessdata.fda.gov |
| December 17, 2025 | K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| December 12, 2025 | K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | Switzerland | Substantially Equivalent | 510(k) special | HSB | accessdata.fda.gov |
| December 5, 2025 | K252151 | els unibond | Saremco Dental AG | Switzerland | Substantially Equivalent | 510(k) traditional | KLE | accessdata.fda.gov |
| November 25, 2025 | K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) traditional | NPL | accessdata.fda.gov |
| November 19, 2025 | K242603 | MyPAO SA guides | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | PBF | accessdata.fda.gov |
| November 14, 2025 | K250501 | System Sophi | This AG | Switzerland | Substantially Equivalent | 510(k) traditional | HQC | accessdata.fda.gov |
| November 12, 2025 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | Switzerland | Substantially Equivalent | 510(k) traditional | NKG | accessdata.fda.gov |
| November 12, 2025 | K243715 | Synthes Patient Specific Implants | Synthes GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | GXN | accessdata.fda.gov |
| October 31, 2025 | K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | PHX | accessdata.fda.gov |
| October 21, 2025 | K253249 | TriALTIS Spine System | Medos International SARL | Switzerland | Substantially Equivalent | 510(k) special | NKB | accessdata.fda.gov |
| September 30, 2025 | K251197 | Dexter L6 System | Distalmotion SA | Switzerland | Substantially Equivalent | 510(k) traditional | SDD | accessdata.fda.gov |
| September 19, 2025 | K250450 | Coated hip implants | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | LZO | accessdata.fda.gov |
| September 18, 2025 | K251377 | Magic InBra | Medela AG | Switzerland | Substantially Equivalent | 510(k) traditional | HGX | accessdata.fda.gov |
| September 16, 2025 | K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | Switzerland | Substantially Equivalent | 510(k) traditional | MSS | accessdata.fda.gov |
| September 12, 2025 | K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | GAT | accessdata.fda.gov |
| September 4, 2025 | K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | SBF | accessdata.fda.gov |
| August 28, 2025 | K243901 | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | Switzerland | Substantially Equivalent | 510(k) traditional | QOG | accessdata.fda.gov |
| August 20, 2025 | K252104 | T1D1 | Comerge AG | Switzerland | Substantially Equivalent | 510(k) traditional | NDC | accessdata.fda.gov |
| August 20, 2025 | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | HSB | accessdata.fda.gov |
| August 14, 2025 | K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte... | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) traditional | NPL | accessdata.fda.gov |
| August 13, 2025 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | Switzerland | Substantially Equivalent | 510(k) traditional | HSB | accessdata.fda.gov |
| August 13, 2025 | K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | Switzerland | Substantially Equivalent | 510(k) traditional | PZL | accessdata.fda.gov |
| August 12, 2025 | K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | Switzerland | Substantially Equivalent | 510(k) traditional | DZE | accessdata.fda.gov |
| August 7, 2025 | K243765 | LuMon(TM) System | Sentec AG | Switzerland | Substantially Equivalent | 510(k) traditional | QEB | accessdata.fda.gov |
| July 31, 2025 | K250477 | NextAR(TM) Spine | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | SBF | accessdata.fda.gov |
| July 31, 2025 | K241461 | Mpact Constrained Liner | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | KWZ | accessdata.fda.gov |
| July 29, 2025 | K251364 | Sleepiz One+ (2.5) | Sleepiz AG | Switzerland | Substantially Equivalent | 510(k) special | DRT | accessdata.fda.gov |
| July 24, 2025 | K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | HSX | accessdata.fda.gov |
| July 17, 2025 | K251556 | Device 300423 Granules | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) traditional | MQV | accessdata.fda.gov |
| July 17, 2025 | K251016 | MectaLIF 3D Metal | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | MAX | accessdata.fda.gov |
| July 11, 2025 | K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) special | NPM | accessdata.fda.gov |
| July 7, 2025 | K251863 | CustomSurg OrthoPlanner | Customsurg AG | Switzerland | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| July 2, 2025 | K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | Switzerland | Substantially Equivalent | 510(k) traditional | DXN | accessdata.fda.gov |
| July 1, 2025 | K251933 | SnugFit ASA Extension | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) special | MBI | accessdata.fda.gov |
| June 27, 2025 | K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | Switzerland | Substantially Equivalent | 510(k) abbreviated | ELW | accessdata.fda.gov |
| June 27, 2025 | K242988 | Genostis Osteosynthesis System | Genostis AF | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| June 26, 2025 | K251613 | SwissGraft X | Geistlich Pharma AG | Switzerland | Substantially Equivalent | 510(k) special | NPM | accessdata.fda.gov |
| June 18, 2025 | K242933 | SPINEART Navigation Instrument System | Spineart SA | Switzerland | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| June 13, 2025 | K251166 | Mfinity Femoral System | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | MEH | accessdata.fda.gov |
| June 11, 2025 | K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | Bonebridge AG | Switzerland | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| May 27, 2025 | K250435 | Dexter L6 System | Distalmotion SA | Switzerland | Substantially Equivalent | 510(k) traditional | SDD | accessdata.fda.gov |
| April 23, 2025 | K243697 | MySpine WebPlanner | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| April 23, 2025 | K243326 | Dynamis Robotic Surgical System | LEM Surgical AG | Switzerland | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| Medacta International S.A. | 23 | September 17, 2026 |
| Geistlich Pharma AG | 10 | June 2, 2026 |
| Institut Straumann AG | 9 | June 3, 2026 |
| Spineart SA | 7 | August 20, 2026 |
| Stryker GmbH | 5 | June 29, 2026 |
| Bonebridge AG | 5 | June 26, 2026 |
| Synthes GmbH | 5 | March 10, 2026 |
| Distalmotion SA | 4 | August 11, 2026 |
| Medartis AG | 4 | June 5, 2026 |
| Medos International SARL | 4 | May 26, 2026 |
| Cascination AG | 3 | October 23, 2026 |
| Hi-D Imaging AG | 2 | July 20, 2026 |
| LEM Surgical AG | 2 | June 20, 2026 |
| Cequr SA | 2 | April 10, 2026 |
| Sleepiz AG | 2 | January 28, 2026 |
| E.M.S Electro Medical Systems S.A | 2 | January 28, 2026 |
| ZuriMED Technologies AG | 2 | January 2, 2026 |
| Icotec AG | 2 | November 12, 2025 |
| Dent4you AG | 2 | June 27, 2025 |
| Aesyra SA | 1 | October 30, 2026 |
By panel
| Panel | Decisions | Latest |
|---|---|---|
| Orthopedic | 52 | October 29, 2026 |
| Dental | 21 | October 8, 2026 |
| Neurology | 13 | October 30, 2026 |
| Radiology | 10 | October 23, 2026 |
| General, Plastic Surgery | 9 | September 5, 2026 |
| General Hospital | 6 | June 3, 2026 |
| Cardiovascular | 5 | August 14, 2026 |
| Unknown | 3 | September 11, 2026 |
| Ophthalmic | 2 | November 14, 2025 |
| Anesthesiology | 2 | August 20, 2025 |
| Physical Medicine | 1 | September 22, 2026 |
| Gastroenterology, Urology | 1 | April 17, 2026 |
| Obstetrics/Gynecology | 1 | September 18, 2025 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| 510(k) traditional | 108 | October 30, 2026 |
| 510(k) special | 17 | October 29, 2026 |
| 510(k) abbreviated | 1 | June 27, 2025 |
Where FDA publishes these decisions
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. Spot a wrong value? Write to [email protected] with the link to this page.