Atlas FDA

FDA clearances & recalls - week 26, 2026

FDA cleared 51 devices through the 510(k) pathway in week 26 of 2026 (2026-06-29 to 2026-07-02), down 25% from the prior week's 68. Dental led with 10 clearances. Average review time for the week's cohort was 138 days; the fastest decision was Dandy Ceramic Stain and Glaze (K262195) at 1 days. FDA also posted 50 device recalls.

51510(k) clearances
50recalls posted
138 daysaverage review, this cohort
-25%vs prior week

By specialty

Dental (10)Cardiovascular (7)General, Plastic Surgery (7)Radiology (6)Orthopedic (6)

Clearances (top 50 of 51)

DeviceApplicantSpecialtyDecidedReview days
iTero Lumina™ Pro Align Technology , Ltd.Dental2026-07-0229
Koios DS (3.8) Koios Medical, Inc.Radiology2026-07-02210
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP C AbbottCardiovascular2026-07-0230
FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscop Fujifilm CorporationGastroenterology, Urology2026-07-0227
OncoStudio Oncosoft. Inc.,Radiology2026-07-02135
Claria System Claria Medical, Inc.Obstetrics/Gynecology2026-07-02329
Insufflation Retention Device (IRD) (11173-325-101) BPEndo, LLCGastroenterology, Urology2026-07-0250
Collagen Wound Powder Ventris MedicalUnknown2026-07-02128
FACE4D Aligner Avinent Implant System S.L.U.Dental2026-07-02135
ILR ECG Analyzer (IM007) Implicity, Inc.Cardiovascular2026-07-02267
Xpert Carba-R Cepheid®Microbiology2026-07-0228
OrthoFit Spident Co., Ltd.Dental2026-07-0287
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Tec O&M Halyard, Inc.General Hospital2026-07-0227
iPredict-DR iHealthscreen, Inc.Ophthalmic2026-07-02220
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) Edan Instruments, Inc.Cardiovascular2026-07-02330
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit Suzhou Precigenome, Ltd. Co;Medical Genetics2026-07-02349
OptraSCAN System Optrascan, Inc.Hematology2026-07-02115
OSSTM Orthopedic Salvage System Biomet, Inc.Orthopedic2026-07-01273
Tetric plus Fill;Tetric plus Flow Ivoclar Vivadent, Inc.Dental2026-07-0157
KHEIRON® Spinal Fixation System, including patient specific S.M.A.I.OOrthopedic2026-07-01215
Chromix Termosalud S.L.General, Plastic Surgery2026-07-0158
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545 Olympus Medical Systems Corp.General, Plastic Surgery2026-07-01196
Enteral Syringe (20ml, 60ml) Chirana T.Injecta,A.S.Gastroenterology, Urology2026-07-01328
Admiral ACP System; Explorer TO System; Laminoplasty System; SeaSpine Orthopedics CorporationOrthopedic2026-07-01273
DENTCA Tru Flexible Dentca, Inc.Dental2026-07-0158
EasyWhip Family Winter Innovations, Inc.General, Plastic Surgery2026-07-0196
Veritas Shoulder System Restor3DOrthopedic2026-07-01132
OTS Hip Ortoma ABNeurology2026-07-0128
Transcend Bulk Fill Flowable Composite Ultradent Products, Inc.Dental2026-07-011
RibPlate System Stryker Leibinger GmbH & Co KGOrthopedic2026-07-0192
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGC Covidien, LLCGeneral Hospital2026-07-01230
Neodent Implant System - NeoConvert Fit JJGC Indústria e Comércio de Materiais Dentários S.A.Dental2026-07-0185
Trevo Trak 21 Microcatheter Stryker NeurovascularCardiovascular2026-07-0126
Dandy Ceramic Stain and Glaze Zima International Inc., dba DandyDental2026-06-301
Ceribell Monitor Ceribell, Inc.Neurology2026-06-3089
ISAAC Neurovascular Navigation Catheter Microvention Inc. d/b/a Terumo NeuroCardiovascular2026-06-3029
UB ERP System Universal BrainNeurology2026-06-30217
NorthStar Mapping System (MAP01 or MAP01-01) Imricor Medical Systems, Inc.Cardiovascular2026-06-3088
MeVis AVM Contour MeVis Medical Solutions AGRadiology2026-06-30130
Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge ( Serpex MedicalGeneral, Plastic Surgery2026-06-3090
Zolid Lunaris Amann Girrbach AGDental2026-06-29102
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) Agada Medical, Ltd.Radiology2026-06-29222
LUTRONIC GENIUS Cynosure Lutronic Technology CorporationGeneral, Plastic Surgery2026-06-29255
LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Ches Guangdong Newdermo Biotech Co., Ltd.General, Plastic Surgery2026-06-2990
Pangea Femur Reconstruction System Stryker GmbHOrthopedic2026-06-2955
Injectable Root Canal Sealer (KP-Root SP) Guilin Kevin Peter Technology Co., Ltd.Dental2026-06-2960
Omnipod 6 algorithm Insulet CorporationClinical Chemistry2026-06-2956
Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, Sterilmed, Inc.Cardiovascular2026-06-29189
Irrigation Tubing Bipolar Cord Set New Deantronics Taiwan , Ltd.General, Plastic Surgery2026-06-29410
Alturion Series Diagnostic Ultrasound System Philips Ultrasound, LLCRadiology2026-06-29119

Recalls posted

ProductRecalling firmPosted
Reprocessed Electrophysiology Catheters and Ultrasound Cathe Medline Industries, LP2026-07-02
Medtronic Harmony Delivery Catheter System Medtronic Heart Valves Division2026-07-02
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-D Covidien LLC2026-07-02
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN05 BD SWITZERLAND SARL2026-07-02
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 011088 Bard Access Systems, Inc.2026-07-02
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Cod Bard Access Systems, Inc.2026-07-02
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Bard Access Systems, Inc.2026-07-02
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Bard Access Systems, Inc.2026-07-02
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 0080 Bard Access Systems, Inc.2026-07-02
5605150 Power-Trialysis Short-Term Straight Dialysis Cathete Bard Access Systems, Inc.2026-07-02
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialys Bard Access Systems, Inc.2026-07-02
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code Bard Access Systems, Inc.2026-07-02
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: Bard Access Systems, Inc.2026-07-02
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UD Bard Access Systems, Inc.2026-07-02
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI Bard Access Systems, Inc.2026-07-02
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00 Bard Access Systems, Inc.2026-07-02
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Cod Bard Access Systems, Inc.2026-07-02
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403 Bard Access Systems, Inc.2026-07-02
Solar GI System (Water Perfusion); Product Name (Catalog Num Laborie Medical Technologies Corp2026-07-02
Radius VSM ECG pre-connected Set, REF: 4842, 4695 Masimo Corporation2026-07-02
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 Masimo Corporation2026-07-02
GORE TAG Thoracic Branch Endoprosthesis Side Branch Componen W L Gore & Associates, Inc.2026-07-02
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 400 Zimmer Surgical Inc2026-07-02
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 400 Zimmer Surgical Inc2026-07-02
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circ Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Cir Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use C Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Baxter Healthcare Corporation2026-07-01
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number Windstone Medical Packaging, Inc.2026-07-01
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Windstone Medical Packaging, Inc.2026-07-01
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number Windstone Medical Packaging, Inc.2026-07-01
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Numbe Windstone Medical Packaging, Inc.2026-07-01
IntelliCuff, Portable automatic cuff pressure controller REF Hamilton Medical AG2026-07-01
CRE Pro Wireguided 6-8mm 240cm Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 8-10mm 240cm Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 10-12mm 240cm Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 12-15mm 240cm Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 15-18mm 240cm Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 18-20mm 240cm Boston Scientific Corporation2026-07-01
CRE Wireguided 6-8mm 240cm Boston Scientific Corporation2026-07-01
CRE Wireguided 8-10mm 240cm Boston Scientific Corporation2026-07-01
CRE Wireguided 10-12mm 240cm Boston Scientific Corporation2026-07-01
CRE Wireguided 12-15mm 240cm Boston Scientific Corporation2026-07-01
CRE Wireguided 15-18mm 240cm Boston Scientific Corporation2026-07-01
CRE Wireguided 18-20mm 240cm Boston Scientific Corporation2026-07-01
Adapter for Head Positioning, Model/Catalog Number: 1739994, Baxter Healthcare Corporation2026-07-01
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb TELEFLEX LLC2026-07-01
Cyberknife Treatment Deliver System equipped with the Xchang Accuray Incorporated2026-07-01
ARTIS icono biplane. Model Number: 11327600. Siemens Medical Solutions USA, Inc2026-07-01
ARTIS icono ceiling. Model Number: 11328100. Siemens Medical Solutions USA, Inc2026-07-01

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