Atlas FDA

FDA clearances & recalls - week 30, 2026

FDA cleared 71 devices through the 510(k) pathway in week 30 of 2026 (2026-07-27 to 2026-07-31), down 10% from the prior week's 79. Radiology led with 19 clearances. Average review time for the week's cohort was 138 days; the fastest decision was NanoCeram Resin (K262681) at 1 days. FDA also posted 50 device recalls.

71510(k) clearances
50recalls posted
138 daysaverage review, this cohort
-10%vs prior week

By specialty

Radiology (19)Cardiovascular (13)Orthopedic (9)Neurology (8)Gastroenterology, Urology (6)

Clearances (top 50 of 71)

DeviceApplicantSpecialtyDecidedReview days
I-Genius (100019400) Esaote, S.p.A.Radiology2026-07-31100
0909FCE, 0909FCE-HS Rayence Co., Ltd.Radiology2026-07-31245
SnØreNegatØr DnB Innovations, LLCDental2026-07-3153
Vertiwedge® Intraosseous System Foundation Surgical GroupOrthopedic2026-07-3160
Affinity Hermes Medical Solutions ABRadiology2026-07-31242
ZSAlign Cervical Interbody System ZSFab, Inc.Orthopedic2026-07-3191
WatchPAT SW Itamar Medical , Ltd.Anesthesiology2026-07-31227
Interwedge® Standalone Lateral Foundation Surgical GroupOrthopedic2026-07-3160
Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethos Shanghai Hulu Devices Co., Ltd.Cardiovascular2026-07-3186
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF- Olympus Medical Systems CorporationGastroenterology, Urology2026-07-31112
MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAG Siemens Healthineers AGRadiology2026-07-31137
Shield System (Siemens 30x40) Radiaction , Ltd.Radiology2026-07-31157
UniPearls® Embolic Microspheres Suzhou Haowei Medical Technology Co., Ltd.Cardiovascular2026-07-31330
da Vinci Surgical System, Model IS5000 Intuitive Surgical, Inc.Gastroenterology, Urology2026-07-3160
Angled Screwdriver MED (M-SD090) W&H Dentalwerk Bürmoos GmbHDental2026-07-31253
VitalFlow Set with Balance™ Biosurface Medtronic, Inc.Cardiovascular2026-07-3199
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACT Globus Medical, Inc.Orthopedic2026-07-3130
LightStim for Wrinkles (1984); LightStim for Acne (2038) Led Intellectual Properties, LLCGeneral, Plastic Surgery2026-07-3187
RadioViewAI Neurocareai, Inc. (Dba Savelife.Ai)Radiology2026-07-31133
xvision Spine system Augmedics, Ltd.Neurology2026-07-3158
NanoCeram Resin 3BFAB TEKNOLOJI A.S.Dental2026-07-311
Hearing Aid Feature Samsung Electronics Co., Ltd.Ear, Nose, Throat2026-07-31112
Flexitouch® Plus Advanced Pneumatic Compression System Tactile MedicalCardiovascular2026-07-31259
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigat Orthalign, Inc.Neurology2026-07-3129
Motivista (CT-155) Click Therapeutics, Inc.Neurology2026-07-30226
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) Salter LabsAnesthesiology2026-07-3093
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Br Philips Medical Systems Nederland B.V.Radiology2026-07-3021
SMARTVERTIGO™ Vestibular Assessment System VertigoDx, Inc.Neurology2026-07-30161
TnR Cranial Implant T&R BIOFAB CO., Ltd.Neurology2026-07-30399
neXus Ultrasonic Surgical Aspirator System Misonix, LLCUnknown2026-07-3090
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001- Suite 201, National Innovation CentreNeurology2026-07-3091
AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-I Stryker EndoscopyOrthopedic2026-07-3020
Obsidian® Press Over Zirconia Prismatik Dentalcraft, Inc.Dental2026-07-3029
cmAngio® V2.0 Curemetrix, Inc.Radiology2026-07-30127
Sync AV II Temporary Pacing Catheter Swift Sync, Inc.Cardiovascular2026-07-30395
SmartGuide Disposable Guides and Grids UC-CARE , Ltd.Radiology2026-07-30191
LOGIQ Focus GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiology2026-07-3058
SeptAlign (SPLN001) Spirair, Inc.Ear, Nose, Throat2026-07-30155
Handheld Ultrasound Scanner IMGFAX CO., LTD.Radiology2026-07-30101
Arthrex Radial Head Replacement System Arthrex, Inc.Orthopedic2026-07-30154
CPS Locator 3D Plus Delivery Catheter CenterPoint Systems, LLCCardiovascular2026-07-2962
Cleerly Plaque Cleerly, Inc.Radiology2026-07-29106
Profoject™ Dual-Safety Pen Needles CMT Health PTE., Ltd.General Hospital2026-07-2957
Suture Button Repair System Skeletal Dynamics, Inc.Orthopedic2026-07-2961
SSPC NXT Delivery Catheter CenterPoint Systems, LLCCardiovascular2026-07-2928
Emanate Tray Emanate BiomedicalUnknown2026-07-29404
Cleerly LABS Cleerly, Inc.Radiology2026-07-29159
SPINEART Navigation Instrument System Spineart SANeurology2026-07-29107
NAMIC Dilator and Sheath Medline Industries, LPCardiovascular2026-07-29258
Stone Clear (BWSC-LP9-02) Sonomotion, Inc.Gastroenterology, Urology2026-07-2930

Recalls posted

ProductRecalling firmPosted
Halyard convenience kits containing recalled Medline Namic A AVID Medical, Inc.2026-07-31
Halyard convenience kits containing recalled Medline Namic A AVID Medical, Inc.2026-07-31
Halyard convenience kits containing recalled Medline Namic A AVID Medical, Inc.2026-07-31
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099 Beckman Coulter Biomedical GmbH2026-07-31
Charger for the Therabody Theragun, G4 PRO massage device, a Therabody, Inc2026-07-31
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). INTEGRATED MEDCRAFT LLC2026-07-31
Kingfisher Compact Individual First Aid Kit. REF Number: 766 INTEGRATED MEDCRAFT LLC2026-07-31
Radial Jaw 4 Standard Capacity Biopsy Forceps with the follo Boston Scientific Corporation2026-07-31
Radial Jaw 4 Large Capacity Biopsy Forceps with the followin Boston Scientific Corporation2026-07-31
Radial Jaw 4 Jumbo Biopsy Forceps with the following descrip Boston Scientific Corporation2026-07-31
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Mod Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Quantum Outback Mode Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Mo Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Cat Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Ca Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/C Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Cata Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Cata Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD M Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Pride Mobility Products Corp.2026-07-31
Brand Name: Quantum Rehab Product Name: Quantum Rival Model/ Pride Mobility Products Corp.2026-07-31
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Numb Copan WASP2026-07-31
Nerivio Infinity. Model/Catalog Number: FGD000100. Software THERANICA BIOELECTRONICS LTD2026-07-31
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands MUNEVO GMBH2026-07-31
Power Over Fiber Base Module Terex Utilities2026-07-30
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medical Action Industries, Inc. 3062026-07-30
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Pre Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Instrumentation Laboratory2026-07-29
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Instrumentation Laboratory2026-07-29
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog N Stryker GmbH2026-07-29
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog N Stryker GmbH2026-07-29
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog N Stryker GmbH2026-07-29
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog N Stryker GmbH2026-07-29
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog N Stryker GmbH2026-07-29
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Stryker GmbH2026-07-29
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Stryker GmbH2026-07-29
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator s ResMed Ltd.2026-07-28
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. IsoTis OrthoBiologics, Inc.2026-07-28
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Bri PHILIPS MEDICAL SYSTEMS2026-07-27
IQon Spectral CT IQon Spectral CT Upgrades PHILIPS MEDICAL SYSTEMS2026-07-27
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT50 PHILIPS MEDICAL SYSTEMS2026-07-27
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intend Medtronic Perfusion Systems2026-07-27
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intend Medtronic Perfusion Systems2026-07-27
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, inte Medtronic Perfusion Systems2026-07-27
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, inte Medtronic Perfusion Systems2026-07-27

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