FDA medical device clearances, approvals and recalls
Search 175,651 510(k) clearances, 1,430 premarket approvals and 53,735 device recalls by K number, device name, manufacturer or product code.
- 33,922 manufacturers
- 7,093 product codes
- 3,631 Class I recalls
- Updated 2026-09-25
Latest 510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262526 | Safety lancet (XL)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 09/13/2026SE |
| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260133 | CaddieQNP · Special | Odin Medical Limited | 09/12/2026SE |
| K262874 | CraniUS PlateGWO · Special | CraniUS, LLC | 09/11/2026SE |
| K262861 | PureLift Pro MaxNFO · Special | Xtreem Pulse, LLC | 09/11/2026SE |
| K262763 | iLet Dosing Decision SoftwareQJI · Traditional | Beta Bionics, Inc. | 09/11/2026SE |
| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K262151 | SpaceOAR Flex SystemOVB · Traditional | Boston Scientific Corporation | 09/11/2026SE |
| K262050 | Vioseal XKIF · Traditional | Spident Co., Ltd. | 09/11/2026SE |
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K262007 | PRIMED AAMI Level 3 Open Back GownsQPC · Traditional | PRIMED Medical Products, Inc. | 09/11/2026SE |
| K261837 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Traditional | Baebies, Inc. | 09/11/2026SE |
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| K261580 | ZBPro Diagnostic (Version 2.0)MLO · Traditional | Zbeats, Inc. | 09/11/2026SE |
Latest recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3214-2026 | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER…Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through… | Boston Scientific Corporation | 08/24/2026Open, Classified |
| Z-3243-2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3242-2026 | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3241-2026 | MR 5300 Model Number (REF): 1. 782110, 2. 782152;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3240-2026 | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3239-2026 | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2.…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3238-2026 | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T)…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3237-2026 | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3236-2026 | Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T)…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3235-2026 | Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3234-2026 | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3233-2026 | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
Top manufacturers
- Abbott Laboratories · 889 510(k)s · 218 recalls
- Siemens Medical Solutions USA, Inc. · 784 510(k)s · 1,156 recalls
- Boston Scientific Corporation · 732 510(k)s · 1,059 recalls
- C.R. Bard, Inc. · 655 510(k)s · 173 recalls
- Bd Becton Dickinson Vacutainer Systems Preanalytic · 632 510(k)s · 0 recalls
- Baxter Healthcare Corp · 568 510(k)s · 564 recalls
- Smith & Nephew, Inc. · 547 510(k)s · 443 recalls
- Medtronic Vascular · 480 510(k)s · 233 recalls
- Roche Diagnostics Corp. · 456 510(k)s · 88 recalls
- Syva Co. · 448 510(k)s · 0 recalls
- Biomet, Inc. · 445 510(k)s · 521 recalls
- Zimmer, Inc. · 422 510(k)s · 974 recalls
- Synthes (Usa) · 418 510(k)s · 3 recalls
- Howmedica Corp. · 409 510(k)s · 0 recalls
- KARL STORZ Endoscopy-America, Inc. · 367 510(k)s · 18 recalls
- Cook, Inc. · 364 510(k)s · 538 recalls
- Arthrex, Inc. · 353 510(k)s · 28 recalls
- Stryker Corporation · 352 510(k)s · 192 recalls
- Dade Behring, Inc. · 343 510(k)s · 5 recalls
- Boehringer Mannheim Corp. · 340 510(k)s · 0 recalls
- 3M Company · 330 510(k)s · 2 recalls
- GE Medical Systems, LLC · 329 510(k)s · 234 recalls
- Cordis Corp. · 328 510(k)s · 129 recalls
- Instrumentation Laboratory CO · 326 510(k)s · 95 recalls
- Diagnostic Products Corp. · 324 510(k)s · 0 recalls
- Bio-Rad · 319 510(k)s · 0 recalls
- Depuy, Inc. · 303 510(k)s · 0 recalls
- Wrightmedicaltechnologyinc · 302 510(k)s · 0 recalls
- Howmedica Osteonics Corp. · 301 510(k)s · 244 recalls
- Roche Diagnostic Systems, Inc. · 296 510(k)s · 0 recalls