Atlas FDA

FDA clearances & recalls - week 29, 2026

FDA cleared 79 devices through the 510(k) pathway in week 29 of 2026 (2026-07-20 to 2026-07-26), up 65% from the prior week's 48. Radiology led with 15 clearances. Average review time for the week's cohort was 131 days; the fastest decision was TheraSphere 360™ Y-90 Management Platform (K262462) at 7 days. FDA also posted 48 device recalls.

79510(k) clearances
48recalls posted
131 daysaverage review, this cohort
+65%vs prior week

By specialty

Radiology (15)Cardiovascular (11)Orthopedic (10)General, Plastic Surgery (8)Gastroenterology, Urology (7)

Clearances (top 50 of 79)

DeviceApplicantSpecialtyDecidedReview days
CorVista System® with PCWP Add-On Analytics For Life, Inc.Cardiovascular2026-07-26251
Corsano CardioWatch 287-2 System Corsano Health B.V.Cardiovascular2026-07-2690
MONARCH™ Platform (MON-000008) Auris Health, Inc.Ear, Nose, Throat2026-07-25170
METICULY Patient-specific CMF solution Meticuly Co., Ltd.Dental2026-07-25302
DIANA ROPCA ApSRadiology2026-07-24183
TheraSphere 360™ Y-90 Management Platform Boston Scientific CorporationRadiology2026-07-247
LumenCare Azure Nucletron B.V.Radiology2026-07-2411
GEN 4 JOY Wheelchair Free Wheelchair MissionPhysical Medicine2026-07-24359
REMEDY POLY+PLUS SNAP FIT Acetabular Cup Osteoremedies, LLCOrthopedic2026-07-2418
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) Thermo Fisher Scientific (Oxoid Ltd.)Microbiology2026-07-2456
Accuro® 3S Needle Guide Kit Rivanna Medical, Inc.Radiology2026-07-24119
Temporary Keratoprosthesis (QuickSet TKP™) Eyekon Medical, Inc.Ophthalmic2026-07-2494
Careflux H60;Careflux H70;Careflux V500 Fresenius Medical Care Renal Therapies Group, LLCGastroenterology, Urology2026-07-2499
PerfusiX-Imaging LIMIS Development B.V.Gastroenterology, Urology2026-07-24213
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Cook Ireland, Ltd.Ear, Nose, Throat2026-07-2498
Tiger 2 System Zavation Medical Products, LLCOrthopedic2026-07-24226
Accuro 3S Rivanna Medical, Inc.Radiology2026-07-24291
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX P Medical ImpactGastroenterology, Urology2026-07-24252
QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET S MANTIZ Co., Ltd.Orthopedic2026-07-24170
Air Compression Massager (EP30B001 I) Wavepulse (Xiamen) Healthcare Technology Co., Ltd.Physical Medicine2026-07-24123
VERAFEYE Imaging Catheter (VF-VIC-002) Luma Vision LimitedCardiovascular2026-07-2451
FARADRIVE™ Steerable Sheath (M004PF21M402) Boston Scientific CorporationCardiovascular2026-07-2428
5 Wavelength LED Facemask (TN2508) iSMART Developments, Ltd.General, Plastic Surgery2026-07-24150
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTI Olympus Surgical Technologies AmericaGeneral, Plastic Surgery2026-07-24101
OBSIDIO Conformable Embolic Boston Scientific CorporationCardiovascular2026-07-2479
TMINI Miniature Robotic System THINK Surgical, Inc.Neurology2026-07-24116
SwiftMR Airs Medical, Inc.Radiology2026-07-2491
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (G Hycor BiomedicalImmunology2026-07-24116
VS-370CF, VS-370CT VISION MEDICAL Co., Ltd.Gastroenterology, Urology2026-07-2429
Ion-L Navigated Instruments SurGenTec, LLCNeurology2026-07-2431
Atellica CH Acetaminophen 2 (ACTM) Siemens Healthcare Diagnostics, Inc.Clinical Toxicology2026-07-2488
DiscreetDuo™ Flow Wearable Breast Pump (Model S3) Shenzhen TPH Technology Co., Ltd.Obstetrics/Gynecology2026-07-24177
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Ge Medical Systems Information Technologies, Inc.Cardiovascular2026-07-24298
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection Deka R&D CorpGeneral Hospital2026-07-24242
dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/ Philips Medical Systems Nederland B.V.Radiology2026-07-2417
Gepotidacin GEP 10 µg Liofilchem, Inc.Microbiology2026-07-2350
Klassic Infection Spacer System Total Joint Orthopedics, Inc.Orthopedic2026-07-2358
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpr Beijing Konted Medical Technology Co.,LtdRadiology2026-07-23113
ImageGrid StreamVue Candelis, Inc.Radiology2026-07-2328
FACEGYM Pro Device (HD-109) Shenzhen Kaiyan Medical Equipment Co., Ltd.Neurology2026-07-23226
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) Microlife CorporationCardiovascular2026-07-23113
VELMENI for DENTISTS (V4D) 3D Velmeni, Inc.Radiology2026-07-23216
Total Flow Medical Femoral Arterial (TFA) cannula Total Flow Medical Limited2026-07-23427
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) Guangzhou Daxin Health Technology Co., Ltd.Cardiovascular2026-07-23107
TRUE METRIX Self Monitoring Blood Glucose System Trividia Health, Inc.Clinical Chemistry2026-07-2330
RXiBreeze PAP System (RXiBreeze 20C) Resvent Medical Technology Co., Ltd.Anesthesiology2026-07-23304
Perfadex Plus Xvivo Perfusion ABGastroenterology, Urology2026-07-2366
3d Cage Cervical Fims Co., Ltd.Orthopedic2026-07-23304
CORE 300 Digital Stethoscope Eko Health, Inc.Cardiovascular2026-07-2362
Dental Cone-beam Computed Tomography (mDX-15P Series) Hefei Meyer Optoelectronic Technology, Inc.Radiology2026-07-2356

Recalls posted

ProductRecalling firmPosted
Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock RE Permobil Inc2026-07-24
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits label Windstone Medical Packaging, Inc.2026-07-24
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits label Windstone Medical Packaging, Inc.2026-07-24
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits label Windstone Medical Packaging, Inc.2026-07-24
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits label Windstone Medical Packaging, Inc.2026-07-24
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga Argon Medical Devices, Inc2026-07-24
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 38462 Argon Medical Devices, Inc2026-07-24
M5 Corpus Power Wheelchair REF,120032 Permobil Inc2026-07-24
MEDLINE medical procedure convenience kit labeled as: HIP CD Medline Industries, LP2026-07-23
MEDLINE medical procedure convenience kit labeled as: 1) TOT Medline Industries, LP2026-07-23
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) Medtronic MiniMed, Inc.2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline convenience kits containing Bard Silastic Foley Cath Medline Industries, LP2026-07-23
Medline medical convenience kits labeled as: 1) KIT PEDIATRI Medline Industries, LP2026-07-23
Medline medical convenience kits labeled as: 1) SHOULDER PAC Medline Industries, LP2026-07-23
Medline medical convenience kits labeled as: NEURO PACK, Med Medline Industries, LP2026-07-23
Medline medical convenience kits labeled as: 1) TOTAL JOINT Medline Industries, LP2026-07-23
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: N Alphatec Spine, Inc.2026-07-23
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, Karl Storz Endoscopy2026-07-23
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G Medline Industries, LP2026-07-22
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline S Medline Industries, LP2026-07-22
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Med Medline Industries, LP2026-07-22
Boston Scientific TheraSphere 360 Y-90 Management Platform, Boston Scientific Corporation2026-07-22
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: AVID Medical, Inc.2026-07-22
Pipeline Flex Embolization Device with Shield Technology, 3. Micro Therapeutics, Inc.2026-07-22
Pipeline Flex Embolization Device with Shield Technology, 3. Micro Therapeutics, Inc.2026-07-22
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. KENT IMAGING, INC.2026-07-22
Olympus High Flow Insufflation Unit - UHI-4. Model Number: U Olympus Corporation of the Americas2026-07-22
Emano Flow with software version v2.0.0 GS1 GTIN code: 19987 Emano Metrics, Inc.2026-07-22
The intended use is to be paired with a weapon for aiming pu Wilcox Industries Corp.2026-07-21
3mensio Workstation (Vascular Fenestrated) software PIE Medical Imaging B.V.2026-07-21
Ventriculostomy Kit, REF: 46154 Medtronic Neurosurgery2026-07-21
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appl Prismatik Dentalcraft, Inc.2026-07-21
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT Penumbra, Inc.2026-07-21
FARADRIVE Steerable Sheath Clear IDE, used to facilitate acc Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate acc Boston Scientific Corporation2026-07-20
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An elect Olympus Corporation of the Americas2026-07-20
SeaSpine Polyaxial Head REF Number: 41-3010 SEASPINE ORTHOPEDICS CORPORATION2026-07-20
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience k AVID Medical, Inc.2026-07-20

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