Atlas FDA

FDA clearances & recalls - week 20, 2026

FDA cleared 78 devices through the 510(k) pathway in week 20 of 2026 (2026-05-18 to 2026-05-24), up 1% from the prior week's 77. General, Plastic Surgery led with 14 clearances. Average review time for the week's cohort was 161 days; the fastest decision was Stelo Glucose Biosensor System (K261359) at 27 days. FDA also posted 19 device recalls.

78510(k) clearances
19recalls posted
161 daysaverage review, this cohort
+1%vs prior week

By specialty

General, Plastic Surgery (14)Cardiovascular (12)Radiology (12)Gastroenterology, Urology (8)Neurology (5)

Clearances (top 50 of 78)

DeviceApplicantSpecialtyDecidedReview days
MediBot Needle Driver Uno Parallel Robotics, LLCGastroenterology, Urology2026-05-24123
Arc Adjustable Radial Cuff Compression Device Tz Medical, Inc.Cardiovascular2026-05-22262
DePuy ATTUNE™ Knee System DePuy Orthopaedics, Inc.Orthopedic2026-05-22254
Spectrum-2 Neko Health ABCardiovascular2026-05-22151
PCWP Analysis Software Cardiosense, Inc.Cardiovascular2026-05-22186
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Acce Senzime ABAnesthesiology2026-05-2250
MagVenture Accelerated TMS (aTMS) Therapy System Tonica Elektronik A/SNeurology2026-05-22120
ATLAAS (Atraumatic Left Atrial Appendage System) (AD) Genesee Biomedical, Inc.General, Plastic Surgery2026-05-22252
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Plan Canon Medical Informatics, Inc.Radiology2026-05-22112
eXaSkin Plus Anatomical Geometry S.L.Radiology2026-05-22262
Zenith Distal Access Long Sheath Suzhou Zenith Vascular SciTech LimitedCardiovascular2026-05-22234
C-beam Pulmera, Inc.Radiology2026-05-22267
InQwire Amplatz Guide Wire Merit Medical Ireland, Ltd.Cardiovascular2026-05-22151
Atmo Gas Capsule System Atmo Biosciences, Ltd.Gastroenterology, Urology2026-05-22186
Ion-C Navigation Instruments SurGenTec, LLCNeurology2026-05-22112
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Contain Taizhou Huangyan Guanhong Plastic Steel Products FactoryGeneral Hospital2026-05-22177
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Uri Vivachek Biotech (Hangzhou) Co., Ltd.Clinical Toxicology2026-05-2235
uMR Astra Shanghai United Imaging Healthcare Co., Ltd.Radiology2026-05-22128
Sterile Latex Powder Free Surgical Gloves Protect Gloves Company LimitedGeneral, Plastic Surgery2026-05-22242
AiSteth® Ai Health Highway India Pvt., Ltd.Cardiovascular2026-05-22252
SonoPort Series Digital Color Doppler Ultrasound System (Son CHISON Medical Technologies Co., Ltd.Radiology2026-05-22163
Apollo TMS Therapy System;Apollo light TMS Therapy System Mag & More GmbHNeurology2026-05-2292
da Vinci Firefly Imaging System Intuitive SurgicalGastroenterology, Urology2026-05-2280
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Ma Dcstar, Inc.Anesthesiology2026-05-21332
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI0 Shenzhen Ulike Smart Electronics Co., Ltd.General, Plastic Surgery2026-05-2129
Nisus NPWT Canister 500-mL (CPC-500) Cork MedicalGeneral, Plastic Surgery2026-05-2131
BAC DeepHealth, Inc.Radiology2026-05-21150
Sofjec (Single use Needle); Sofjec (Single use Syringe with Hlb Lifescience Co., Ltd.General Hospital2026-05-21239
DCMhotbond zircon Dental Creativ Management GmbHDental2026-05-21237
Boston 2910 (Boston 2910) Boston Aesthetics, Inc.General, Plastic Surgery2026-05-21234
Ulthera® System Ulthera, Inc.General, Plastic Surgery2026-05-2185
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Olympus Medical Systems Corp.Gastroenterology, Urology2026-05-2190
MuCover (proposed name) Oral Wound Dressing MoleculeX Co., Ltd.Unknown2026-05-21174
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2 Olympus Winter & Ibe GmbHGastroenterology, Urology2026-05-2183
PanopticAI Vital Signs (1.6.1-22) PanopticAI Technologies LimitedCardiovascular2026-05-21132
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) C Pegavision CorporationOphthalmic2026-05-21233
pjur NATURE Touch, 100 ml Pjur Group Luxembourg S.A.Obstetrics/Gynecology2026-05-21132
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (113647 Siemens Medical Solutions USA, Inc.Radiology2026-05-2130
ROSA® Shoulder System Orthosoft Inc. (d/b/a) Zimmer CASNeurology2026-05-2190
Sphincterotome Taewoong Medical Co., Ltd.Gastroenterology, Urology2026-05-2159
Wearable Breast Pump (Model S39) Shenzhen TPH Technology Co., Ltd.Obstetrics/Gynecology2026-05-21143
Stelo Glucose Biosensor System Dexcom, Inc.Clinical Chemistry2026-05-2127
DeepView AI® System Spectralmd, Inc.General, Plastic Surgery2026-05-21328
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) Drägerwerk AG Co. KgaaAnesthesiology2026-05-21265
MSK Go Smart Alfa Teknoloji San. Ve Tic. A.S.Radiology2026-05-21115
Manual Wheelchair (DY01903(2)) Guangdong Dayang Medical Technology Co., Ltd.Physical Medicine2026-05-21150
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, Sofradim ProductionGeneral, Plastic Surgery2026-05-21162
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Wuhan United Imaging Healthcare Co.,LtdRadiology2026-05-21178
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL Shenzhen Xiazhifeng Electronic Co., Ltd.General, Plastic Surgery2026-05-2086
WAVE PTA Balloon Catheter WAVE Medical AGCardiovascular2026-05-20110

Recalls posted

ProductRecalling firmPosted
RelayPro Thoracic Stent-Graft System (various sizes) Referen Bolton Medical Inc.2026-05-22
Automated Impella Controller (AIC); Product Code: 0042-0000- Abiomed, Inc.2026-05-22
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference N O&M HALYARD INC2026-05-22
Philips Azurion systems not configured with an optional auxi PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-21
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc C.R. Bard Inc2026-05-21
Azurion system; System Code Description (Model Numbers): Azu PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-21
Allura system; System Code Description (Model Numbers): Allu PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-21
Integris-Allura system; System Code Description (Model Numbe PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-21
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small Novapproach Spine, LLC2026-05-20
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Medtronic Perfusion Systems2026-05-20
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Bod Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Bod Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Bod Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Bod Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Bod Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Bod Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Bod Medtronic Perfusion Systems2026-05-20
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w ICU Medical, Inc.2026-05-18

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