# FDA device clearances in Pennsylvania: 213 since Nov 2024

Updated October 30, 2026.

FDA made 213 device decisions for applicants in Pennsylvania from November 15, 2024 to October 30, 2026: 166 510(k) clearances and De Novo grants and 47 PMA approvals and supplements, for 74 applicants. The newest, K261072 on October 30, 2026, is DS Core Detect from Dentsply Sirona, Inc..

## The full list

FDA device clearances for applicants in Pennsylvania: 213 rows for $10.65, 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 9 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/state/pennsylvania

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: 213
- 510(k) and De Novo: 166
- PMA: 47
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 213, 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 | K261072 | DS Core Detect | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | MYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261072) |
| October 30, 2026 | K253095 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | MRN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253095) |
| October 29, 2026 | K260975 | Libertas Acetabular Liners (Acetabular Liner) | Maxx Orthopedics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | JDI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260975) |
| October 27, 2026 | K260520 | Skin Clinic Nitro Clear for Warts and Skin Tags | Cryoconcepts LP | Pennsylvania | Substantially Equivalent | 510(k) traditional | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260520) |
| October 23, 2026 | K263407 | Tempo Plating System | Pace Surgical | Pennsylvania | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263407) |
| October 23, 2026 | K262779 | ANTHEM™ Fracture System | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262779) |
| October 22, 2026 | K260261 | Gravity Blood Sets with 200µm Filter | B.Braun Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260261) |
| October 9, 2026 | K260080 | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler | Medical Components, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | LJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260080) |
| October 7, 2026 | K263159 | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments | Centinel Spine, LLC | Pennsylvania | Substantially Equivalent | 510(k) special | QLQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263159) |
| October 6, 2026 | P010030/S205 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S205) |
| October 6, 2026 | K262043 | MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12)... | Bayer Medical Care, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | DXT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262043) |
| October 5, 2026 | P010030/S204 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S204) |
| October 2, 2026 | K260044 | Ventricular Catheters, Thomale Catheter | Aesculap, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | JXG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260044) |
| September 29, 2026 | P010030/S203 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S203) |
| September 28, 2026 | K260474 | Liora Monofilament Scaffold | TELA Bio, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | FTL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260474) |
| September 25, 2026 | P240012/S008 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | Approved | PMA real-time process supplement | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S008) |
| September 25, 2026 | K261262 | Altis Full Face Mask | Respironics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261262) |
| September 18, 2026 | K254160 | VacHeal Negative Pressure Wound Therapy System | VacHeal, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | OKO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254160) |
| September 18, 2026 | K254095 | 25G Huber Needle | Martech Medical Products | Pennsylvania | Substantially Equivalent | 510(k) traditional | PTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254095) |
| September 11, 2026 | K254072 | BoneVue | Curvebeam AI / Curvebeam, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | KGI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254072) |
| September 10, 2026 | K254111 | Irrigation/Urology Sets | B.Braun Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | LJH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254111) |
| September 9, 2026 | P070001/S031 | prodisc® C Nova | Centinel Spine, LLC | Pennsylvania | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070001S031) |
| September 9, 2026 | P010030/S201 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | Approved | PMA real-time process supplement | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S201) |
| September 4, 2026 | K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261935) |
| September 3, 2026 | K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | Pennsylvania | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261647) |
| September 2, 2026 | K253065 | Aevumed SUPERCYNCH™ Button System | Aevumed, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253065) |
| August 31, 2026 | K260488 | MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | KPR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260488) |
| August 28, 2026 | K253954 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | QRY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253954) |
| August 24, 2026 | K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | Pennsylvania | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260106) |
| August 21, 2026 | K262127 | DS Core CBCT Anatomy | Dentsply Sirona | Pennsylvania | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262127) |
| August 14, 2026 | K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | Pennsylvania | Substantially Equivalent | 510(k) special | KNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261890) |
| August 7, 2026 | P020012/S051 | SANAE® | Tiger Aesthetics Medical, LLC | Pennsylvania | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020012S051) |
| August 7, 2026 | K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261563) |
| August 5, 2026 | K261380 | Concentriq AP-Dx | Proscia, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | QKQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261380) |
| August 4, 2026 | K261609 | Freedom Partial Knee System | Maxx Orthopedics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | HSX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261609) |
| August 4, 2026 | K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | LPH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254043) |
| July 31, 2026 | K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) special | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262251) |
| July 30, 2026 | P010030/S202 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S202) |
| July 9, 2026 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | DSH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260157) |
| July 1, 2026 | P140011/S009 | MAMMOMAT B.brilliant with Tomosynthesis Option | Siemens Medical Solutions USA, Inc. | Pennsylvania | Approved | PMA 180-day supplement | OTE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140011S009) |
| June 22, 2026 | P240012/S007 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | Approved | PMA 180-day supplement | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S007) |
| June 22, 2026 | P240012/S006 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | Approved | PMA real-time process supplement | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S006) |
| June 18, 2026 | K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | Pennsylvania | Substantially Equivalent | 510(k) special | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261651) |
| June 18, 2026 | K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | MUE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253678) |
| June 18, 2026 | K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | KGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253521) |
| June 12, 2026 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261207) |
| June 12, 2026 | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | PQH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253688) |
| June 11, 2026 | K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254087) |
| June 10, 2026 | K260810 | Anteralign LS coverplate | Tyber Medical, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | OVD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260810) |
| May 29, 2026 | K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261060) |
| May 15, 2026 | P010030/S200 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S200) |
| May 15, 2026 | K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253235) |
| May 14, 2026 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253372) |
| May 13, 2026 | K253061 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | QCF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253061) |
| May 12, 2026 | P020012/S052 | Bellafill® Dermal Filler | Tiger Aesthetics Medical, LLC | Pennsylvania | 30-day notice accepted | PMA 30-day notice | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020012S052) |
| May 7, 2026 | K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System... | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253739) |
| May 4, 2026 | K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254019) |
| April 30, 2026 | P900066/S017 | ISPAN Perfluoropropane C3F8 Gas | Airgas Therapeutics, LLC | Pennsylvania | 30-day notice accepted | PMA 30-day notice | LPO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P900066S017) |
| April 29, 2026 | K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254184) |
| April 29, 2026 | K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | OVD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253401) |
| April 24, 2026 | K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) special | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261043) |
| April 24, 2026 | K260411 | PC Fix System | Chest Wall Innovations, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260411) |
| April 24, 2026 | K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254173) |
| April 23, 2026 | K260785 | DS Core CBCT Anatomy | Dentsply Sirona | Pennsylvania | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260785) |
| April 23, 2026 | K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253752) |
| April 16, 2026 | K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | DWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260903) |
| April 15, 2026 | K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | NXC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260722) |
| April 3, 2026 | K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253042) |
| March 26, 2026 | K260601 | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | Pennsylvania | Substantially Equivalent | 510(k) special | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260601) |
| March 26, 2026 | K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253549) |
| March 23, 2026 | K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260112) |
| March 20, 2026 | K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | Pennsylvania | Substantially Equivalent | 510(k) traditional | EHD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253864) |
| March 13, 2026 | K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | Pennsylvania | Substantially Equivalent | 510(k) special | DXF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253799) |
| March 12, 2026 | K260502 | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | Pennsylvania | Substantially Equivalent | 510(k) traditional | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260502) |
| March 4, 2026 | K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254306) |
| March 4, 2026 | K253565 | SureSmile Software | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | PNN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253565) |
| March 3, 2026 | K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | Pennsylvania | Substantially Equivalent | 510(k) traditional | KLE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260682) |
| February 26, 2026 | K252166 | RIB LINK™ Fixation System | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252166) |
| February 20, 2026 | P240012/S005 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | Approved | PMA 180-day supplement | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S005) |
| February 13, 2026 | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | DXT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252891) |
| February 9, 2026 | K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254236) |
| February 6, 2026 | K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251614) |
| February 5, 2026 | K253959 | Primevision 3D | Dentsply Sirona | Pennsylvania | Substantially Equivalent | 510(k) traditional | OAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253959) |
| January 29, 2026 | P010030/S199 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S199) |
| January 29, 2026 | K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251427) |
| January 29, 2026 | K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent... | HR Healthcare | Pennsylvania | Unknown | 510(k) traditional | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251274) |
| January 28, 2026 | K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | Pennsylvania | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260004) |
| January 15, 2026 | P070001/S030 | prodisc® C | Centinel Spine, LLC | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070001S030) |
| January 15, 2026 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253171) |
| January 14, 2026 | P240012/S004 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | 30-day notice accepted | PMA 30-day notice | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S004) |
| January 12, 2026 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | Pennsylvania | Substantially Equivalent | 510(k) traditional | EBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251701) |
| January 8, 2026 | K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | Pennsylvania | Substantially Equivalent | 510(k) traditional | ODP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252711) |
| January 7, 2026 | K253009 | DS Core Detect | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | MYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253009) |
| December 31, 2025 | K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252901) |
| December 29, 2025 | K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | Pennsylvania | Substantially Equivalent | 510(k) traditional | HTY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253325) |
| December 22, 2025 | K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) special | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253876) |
| December 22, 2025 | K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | DRN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250756) |
| December 16, 2025 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | OVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250925) |
| December 11, 2025 | P010030/S198 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S198) |
| December 9, 2025 | P010030/S197 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | Pennsylvania | Approved | PMA real-time process supplement | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S197) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Globus Medical, Inc. | 19 | October 23, 2026 |
| Zoll Manufacturing Corporation | 18 | October 6, 2026 |
| Dentsply Sirona, Inc. | 15 | October 30, 2026 |
| Maxx Orthopedics, Inc. | 12 | October 29, 2026 |
| Centinel Spine, LLC | 12 | October 7, 2026 |
| Lungpacer Medical USA, Inc. | 9 | September 25, 2026 |
| Siemens Medical Solutions USA, Inc. | 9 | August 31, 2026 |
| Dentsply Sirona | 8 | August 21, 2026 |
| Tyber Medical, LLC | 8 | June 12, 2026 |
| Aevumed, Inc. | 5 | September 2, 2026 |
| B.Braun Medical, Inc. | 4 | October 22, 2026 |
| Bayer Medical Care, Inc. | 4 | October 6, 2026 |
| Tiger Aesthetics Medical, LLC | 4 | August 7, 2026 |
| Blue Belt Technologies, Inc. | 4 | March 26, 2026 |
| Airgas Therapeutics, LLC | 3 | October 30, 2026 |
| Cryoconcepts LP | 3 | October 27, 2026 |
| Pace Surgical | 3 | October 23, 2026 |
| Aesculap, Inc. | 3 | October 2, 2026 |
| Hiossen, Inc. | 3 | May 14, 2026 |
| Mr Surgical Solutions, LLC | 3 | September 10, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 66 | October 29, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 25 | October 6, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 22 | August 28, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 21 | October 30, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 17 | October 2, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 16 | October 30, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 12 | October 27, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 12 | October 22, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 10 | September 10, 2026 |
| Unknown | 4 | June 18, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 2 | April 30, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 2 | December 16, 2025 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 2 | November 5, 2025 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 1 | August 5, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 1 | April 30, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 140 | October 30, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 26 | October 6, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 23 | October 23, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 10 | September 9, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 7 | September 25, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 2 | July 17, 2025 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 2 | June 5, 2025 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 1 | October 10, 2025 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | April 9, 2025 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 1 | December 4, 2024 |

## 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/).