FDA clearances & recalls - week 22, 2026
FDA cleared 75 devices through the 510(k) pathway in week 22 of 2026 (2026-06-01 to 2026-06-05), up 29% from the prior week's 58. General, Plastic Surgery led with 10 clearances. Average review time for the week's cohort was 158 days; the fastest decision was BracePaste Prime Plus (K261840) at 1 days. FDA also posted 50 device recalls.
75510(k) clearances
50recalls posted
158 daysaverage review, this cohort
+29%vs prior week
By specialty
Clearances (top 50 of 75)
| Device | Applicant | Specialty | Decided | Review days |
|---|---|---|---|---|
| EyeBOX SNAP | Oculogica, Inc. | Neurology | 2026-06-05 | 169 |
| FieldFlex Steerable Sheath | CenterPoint Systems, LLC | Cardiovascular | 2026-06-05 | 30 |
| VEOFIX Snap Off Screw | Steps Ortho | Orthopedic | 2026-06-05 | 254 |
| Temperature probes (T2252-PG); Temperature probes (TCMA-AG); | Unimed Medical Supplies, Inc. | General Hospital | 2026-06-05 | 252 |
| Alma TED+ System | Alma Lasers, Inc. | Physical Medicine | 2026-06-05 | 368 |
| Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | Cardiovascular | 2026-06-05 | 127 |
| Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | General Hospital | 2026-06-05 | 126 |
| Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | Cardiovascular | 2026-06-05 | 143 |
| Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antig | Assure Tech., LLC | Microbiology | 2026-06-05 | 88 |
| Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | 2026-06-05 | 148 |
| APTUS Clavicle System 2.8 | Medartis AG | Orthopedic | 2026-06-05 | 88 |
| Catalyze | BioTissue Holdings, Inc. | Unknown | 2026-06-05 | 252 |
| iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems w | Nextstep Arthopedix, LLC | Orthopedic | 2026-06-05 | 613 |
| OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation Sy | Medtronic Sofamor Danek USA, Inc. | General, Plastic Surgery | 2026-06-05 | 197 |
| Digital C-ARM with 3D | Allengers Medical Systems Limited | Radiology | 2026-06-05 | 249 |
| LUNA 3D | Lap GmbH Laser Applikationen | Radiology | 2026-06-04 | 258 |
| LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | General, Plastic Surgery | 2026-06-04 | 93 |
| Radius VSM and Accessories | Masimo Corporation | Cardiovascular | 2026-06-04 | 157 |
| Precision S 4K Sinuscope | Stryker Endoscopy | Neurology | 2026-06-04 | 198 |
| Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | Obstetrics/Gynecology | 2026-06-04 | 258 |
| Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | Orthopedic | 2026-06-04 | 28 |
| Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | Radiology | 2026-06-04 | 258 |
| Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | Radiology | 2026-06-04 | 94 |
| Orion | Resmed Corp | Anesthesiology | 2026-06-04 | 202 |
| Sonio Suspect | Sonio | Radiology | 2026-06-04 | 28 |
| TroKit Laparoscope Lens Wiper | TroCare, LLC | Gastroenterology, Urology | 2026-06-04 | 174 |
| Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | Gastroenterology, Urology | 2026-06-04 | 174 |
| Spectra Platinum Mini | Uzinmedicare Co., Ltd. | Obstetrics/Gynecology | 2026-06-04 | 73 |
| Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large ( | New York Embroidery Studio (NYES) | General, Plastic Surgery | 2026-06-04 | 294 |
| Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | Radiology | 2026-06-04 | 182 |
| GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | General, Plastic Surgery | 2026-06-04 | 253 |
| LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | Microbiology | 2026-06-04 | 87 |
| DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | Radiology | 2026-06-04 | 111 |
| Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Cardiovascular | 2026-06-03 | 251 |
| HeartFocus | Deski | Radiology | 2026-06-03 | 85 |
| CustoMED Viewer | CustoMED , Ltd. | Radiology | 2026-06-03 | 140 |
| Roosin Collagen Dressing | Roosin Medical Co., Ltd. | Unknown | 2026-06-03 | 174 |
| BracePaste Prime Plus | American Orthodontics | Dental | 2026-06-03 | 1 |
| MeRT System | Wave Neuroscience | Neurology | 2026-06-03 | 117 |
| Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. | Unknown | 2026-06-03 | 34 |
| VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | Dental | 2026-06-03 | 2 |
| BioWave BioWraps | Biowave Corporation | Neurology | 2026-06-03 | 27 |
| Powder Free Blue Nitrile Examination Glove - Tested for Use | S&S Glove Corporation | General Hospital | 2026-06-03 | 91 |
| CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | General, Plastic Surgery | 2026-06-03 | 90 |
| KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG | Gastroenterology, Urology | 2026-06-03 | 273 |
| Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | General Hospital | 2026-06-03 | 90 |
| VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Neurology | 2026-06-03 | 133 |
| Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | Physical Medicine | 2026-06-03 | 118 |
| Nitrile Disposable Examination Gloves | Vista Industries,, LLC | General Hospital | 2026-06-03 | 83 |
| SteriTite Container System with MediTray Products | Case Medical, Inc. | General Hospital | 2026-06-03 | 268 |
Recalls posted
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