Atlas FDA

FDA clearances & recalls - week 28, 2026

FDA cleared 48 devices through the 510(k) pathway in week 28 of 2026 (2026-07-13 to 2026-07-17), down 8% from the prior week's 52. Orthopedic led with 10 clearances. Average review time for the week's cohort was 138 days; the fastest decision was Aventus Thrombectomy System (K262030) at 28 days. FDA also posted 26 device recalls.

48510(k) clearances
26recalls posted
138 daysaverage review, this cohort
-8%vs prior week

By specialty

Orthopedic (10)Cardiovascular (7)Radiology (6)General, Plastic Surgery (4)Obstetrics/Gynecology (4)

Clearances

DeviceApplicantSpecialtyDecidedReview days
Diode laser hair removal machine (QDTM-04) Beijing Nubway S&T Co., Ltd.General, Plastic Surgery2026-07-1756
ZEISS CLINIC 360 Carl Zeiss Meditec, AGRadiology2026-07-17136
LED LCD Monitor (OEV-271H) Lg Electronics.IncGastroenterology, Urology2026-07-1763
Natural Cycles Natural Cycles Nordic ABObstetrics/Gynecology2026-07-17238
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tri Stryker SpineOrthopedic2026-07-1729
Drivewire 35 Guidewire Rapid Medical Ltd.Cardiovascular2026-07-17214
LoFric Origo Pro Coudé Wellspect ABGastroenterology, Urology2026-07-1759
Cubresa BrainPET Cubresa, Inc.Radiology2026-07-17218
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit Biofire Defense, LLCMicrobiology2026-07-1773
SportSuite Vision Software Stryker EndoscopyOrthopedic2026-07-17318
Virasight Virasoft CorporationPathology2026-07-17387
AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Assure Tech., LLCClinical Toxicology2026-07-1735
CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK- Shenzhen Chuanghong Zhilian Technology Co., Ltd.Physical Medicine2026-07-1757
Catalyft PL Expandable Interbody System Medtronic Sofamor Danek USA, Inc.Orthopedic2026-07-17301
Dental Zirconia Blank & Coloring Liquid Hunan Qinghao Puzhong Technology Co., Ltd.Dental2026-07-17108
cobas® BV/CV Roche Molecular Systems, Inc.Microbiology2026-07-16192
Skin Air Cooling System (QALF-01) Beijing Nubway S&T Co., Ltd.General, Plastic Surgery2026-07-1656
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed No TriMed, Inc.Orthopedic2026-07-1629
Cable-Ready® Cable Grip System Pioneer Surgical Technology, Inc.Orthopedic2026-07-1690
Palisades™ Buttress Plate System Bethesda Medical Devices, LLCOrthopedic2026-07-1686
Socrates Aspiration System (Socrates 70 Aspiration Catheter) Scientia Vascular, Inc.Cardiovascular2026-07-16195
Endomat Select (UP220) KARL STORZ SE & CO. KGObstetrics/Gynecology2026-07-1655
Aventus Thrombectomy System Inquis MedicalCardiovascular2026-07-1528
Profoject™ Pen Needles (Model A; Model B) CMT Health PTE., Ltd.General Hospital2026-07-15131
WRAP System Huneo, LLCAnesthesiology2026-07-15189
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tes Kyocera Medical Technologies, Inc.Orthopedic2026-07-1582
NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Sli Hamamatsu Photonics K.K.Pathology2026-07-15239
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant Atlas Spine, Inc.Orthopedic2026-07-15314
ThinkSono Guidance ThinkSono GmbHRadiology2026-07-15163
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, X Dongguan Miqiang Technology Co., Ltd.General, Plastic Surgery2026-07-1577
SkeletonPlanner UPlanner B.V. - PresurgeoRadiology2026-07-15173
EnSite™ X EP System Abbott MedicalCardiovascular2026-07-1530
Better Diagnostics Dental Assist (BDDA) Version 1.0 Better Diagnostics AI Corp.Radiology2026-07-15121
Symmetrix™ L Spinal System Medtronic Sofamor Danek USA, Inc.Orthopedic2026-07-14109
LIXI (LXOSFM1) Luwi, LLCObstetrics/Gynecology2026-07-14236
Invictus® Small Stature Spinal Fixation System; Invictus® 2. Alphatec Spine, Inc.Orthopedic2026-07-1488
IERO Mobility Scooter (IERO-01) Jochu Technology Co., Ltd.Physical Medicine2026-07-1490
Universal Seal (5-12 mm) Intuitive Surgical, Inc.Gastroenterology, Urology2026-07-1489
VisuBreath Affirm Medical Technologies II, LLCAnesthesiology2026-07-1457
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, Ambu A/SNeurology2026-07-14144
Accoat Guide Wire Sp Medical A/SCardiovascular2026-07-14235
Hearing assist Meta Platform Technologies, LLCEar, Nose, Throat2026-07-13208
Rapid Vessel Occlusion (Rapid VO) iSchemaviewRadiology2026-07-13103
Ultra-Fine™ SAFETY Insulin Syringe embecta Medical II, LLCGeneral Hospital2026-07-13171
Wearable Breast Pump (Model S32A) Shenzhen TPH Technology Co., Ltd.Obstetrics/Gynecology2026-07-1391
Volnewmer™ Classys, Inc.General, Plastic Surgery2026-07-13255
Merit MAK Nitinol/Gold-Tungsten Guide Wire Merit Medical Ireland , Ltd.Cardiovascular2026-07-1356
SLIM Microcatheter Balt USA, LLCCardiovascular2026-07-13172

Recalls posted

ProductRecalling firmPosted
FARASTAR Ablation Generator EU, Pulsed Field Ablation Genera Boston Scientific Corporation2026-07-17
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFC Boston Scientific Corporation2026-07-17
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutane Boston Scientific Corporation2026-07-17
FARASTAR Ablation Generator EU, Pulsed Field Ablation Genera Boston Scientific Corporation2026-07-17
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC Paragon 28, Inc.2026-07-17
Hotline Fluid Warming Set, single use device, is designed to ICU Medical Inc.2026-07-17
Power F2 Powered Fastening System, Product No. 0567091 Power Ferno-Washington Inc2026-07-17
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for t Tosoh Bioscience Inc2026-07-16
Papablic Replacement Brush Heads. Model Number: Papablic18B Papablic Inc2026-07-15
Papablic Replacement Brush Heads. Model Number: PAPA317AA. Papablic Inc2026-07-15
Medline Kits containing Zimmer Biomet mixing bowls and spatu Medline Industries, LP2026-07-15
Medline Kits containing Zimmer Biomet mixing bowls and spatu Medline Industries, LP2026-07-15
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Medtronic Perfusion Systems2026-07-15
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN Medtronic Perfusion Systems2026-07-15
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Inte 3B Medical, Inc.2026-07-15
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System ( Maquet Cardiovascular, LLC2026-07-15
Photera 400, phototherapy device; Ultraviolet Lamp For Derma Daavlin Distributing Company2026-07-15
Photera 600, phototherapy device; Ultraviolet Lamp For Derma Daavlin Distributing Company2026-07-15
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For D Daavlin Distributing Company2026-07-15
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: Orthofix U.S. LLC2026-07-14
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral o Orthofix U.S. LLC2026-07-14
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M Orthofix U.S. LLC2026-07-14
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: Orthofix U.S. LLC2026-07-14
Optima XR200amx, Mobile Digital-Ready Radiographic System GE Medical Systems, LLC2026-07-13
Optima XR220amx, Mobile Digital-Ready Radiographic System GE Medical Systems, LLC2026-07-13
Optima XR240amx, Mobile Digital Radiographic System GE Medical Systems, LLC2026-07-13

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