Atlas FDA

FDA clearances & recalls - week 31, 2026

FDA cleared 55 devices through the 510(k) pathway in week 31 of 2026 (2026-08-03 to 2026-08-07), down 23% from the prior week's 71. Gastroenterology, Urology led with 9 clearances. Average review time for the week's cohort was 162 days; the fastest decision was Alturion Series Diagnostic Ultrasound System (K262311) at 27 days. FDA also posted 50 device recalls.

55510(k) clearances
50recalls posted
162 daysaverage review, this cohort
-23%vs prior week

By specialty

Gastroenterology, Urology (9)Radiology (8)Orthopedic (8)Cardiovascular (5)General, Plastic Surgery (5)

Clearances (top 50 of 55)

DeviceApplicantSpecialtyDecidedReview days
Zamenix™ P Roen Surgical, Inc.Gastroenterology, Urology2026-08-07280
Intuitive Endoluminal Gastrointestinal System (IG1000) Intuitive Surgical, Inc.Gastroenterology, Urology2026-08-07256
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) Lakong Medical Devices Co., Ltd.Dental2026-08-07444
BUM Oil Bumlicious, LLC (DBA “Bumlicious”)Obstetrics/Gynecology2026-08-0760
mdprostate Mediaire GmbHRadiology2026-08-07358
Mistral-Air® Warming System The Surgical Company International B.V., doing business as TSC LifeCardiovascular2026-08-0799
Zenition 30 Philips Medical Systems Nederland B.V.Radiology2026-08-07221
Metrix COVID Test; Metrix COVID Test Pro Aptitude Medical Systems, Inc.Microbiology2026-08-07305
Xpert Hemorrhagic Fever CepheidImmunology2026-08-07102
Aperio GT 450 DX; Aperio GT 180 DX Leica Biosystems Imaging, Inc.Pathology2026-08-07266
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) Yadu Medical (Henan) Co., Ltd.General, Plastic Surgery2026-08-07130
Aperio iQC DX Software Leica Biosystems Imaging, Inc.Pathology2026-08-07263
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR- Hangzhou Qiantang Longyue Biotechnology Co., Ltd.General Hospital2026-08-07140
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) Shenzhen Chuangtong Yigou Technology Co., Ltd.General, Plastic Surgery2026-08-0785
PacTemp Automix NE The Belport Company Inc., DBA Gingi-PakDental2026-08-0758
Arthrex Bioabsorbable PushLock Suture Anchors Arthrex, Inc.Orthopedic2026-08-0728
Venue Go GE Medical Systems Ultrasound and Primary care Diagnostics, LLCRadiology2026-08-0779
Freedom Total Knee System (E-Poly Tibial Liners) Maxx Orthopedics, Inc.Orthopedic2026-08-0788
EW10-EC02 Endoscopy Support Program Fujifilm CorporationGastroenterology, Urology2026-08-07169
Universal Base ASC Engaging; Universal Base ASC Non-Engaging Nobel Biocare ABDental2026-08-06234
Overjet Multi-Image Caries and Charting Assist Overjet, Inc.Radiology2026-08-06128
Megalodon Dynamic Compression System Paragon 28, Inc.Orthopedic2026-08-06125
Aristotle Mini Guidewire Scientia Vascular, Inc.Cardiovascular2026-08-06192
Telemetry Monitor (iT30, iT50) Edan Instruments, Inc.Cardiovascular2026-08-06447
Manual Wheelchair (H008, PCK7) Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.Physical Medicine2026-08-0686
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 3 Mozarc Medical Us, LLCGastroenterology, Urology2026-08-06300
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpi Howmedica Osteonics Corp. dba Stryker OrthopaedicsOrthopedic2026-08-0662
QIAstat-Dx BCID GPF Plus AMR Panel QIAGEN GmbHMicrobiology2026-08-06226
CAD - Lower GI (EC07-01) Xiamen Inno Medical Technology Co., Ltd.Gastroenterology, Urology2026-08-05331
Huahong Sharps Container (HHR-I, HHR-II) Tianjin Huahong Technology Co., Ltd.General Hospital2026-08-05142
Transurethral Catheter Safety Valve (TUCSV) (80050) Class Medical , Ltd.Gastroenterology, Urology2026-08-05139
Ruthinium Disc Dental Manufacturing S.p.A.Dental2026-08-0596
pVasc Net Mechanical Thrombectomy Device Vesalio, Inc.2026-08-05219
Leksell® Vantage Stereotactic System Elekta Solutions ABNeurology2026-08-0557
NaturaJel™ Oral Wound Care Kit HCS Innovation, LLCUnknown2026-08-05202
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Fe ConvatecGastroenterology, Urology2026-08-05152
Rusch Latex Gold Foley Catheter Teleflex Medical Sdn. Bhd.Gastroenterology, Urology2026-08-0548
GFS - Sterile Screws and Top Hat T.A.G. Medical Products Corporation, Ltd.Orthopedic2026-08-05245
Concentriq AP-Dx Proscia, Inc.Pathology2026-08-05100
OMNI Ultra Surgical System (1-110) Sight Sciences, Inc.General Hospital2026-08-04252
LED Light Therapy Masks (PE748, PE749, PE756) Duplex International Trading LimitedGeneral, Plastic Surgery2026-08-0490
LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Shenzhen Qianyu Technology Co., Ltd.General, Plastic Surgery2026-08-0462
Marrow Marxman Medimetrix, LLCGastroenterology, Urology2026-08-04166
Vertex™ Thrombectomy System Jupiter EndovascularCardiovascular2026-08-0489
TRIVANCE™ Hip Stem Globus Medical, Inc.Orthopedic2026-08-04230
RealGUIDE 3DIEMME SRLRadiology2026-08-04242
Alturion Series Diagnostic Ultrasound System Philips Ultrasound, LLCRadiology2026-08-0427
VueJect® Ultrasound Enhancing Agent Delivery System ACIST Medical Systems, Inc.Cardiovascular2026-08-0341
Halcyon, Ethos Radiotherapy System (5.0) Varian Medical Systems, Inc.Radiology2026-08-0360
Grappler Suture Anchor System Paragon 28, Inc.Orthopedic2026-08-0346

Recalls posted

ProductRecalling firmPosted
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BO MICROVENTION INC.2026-08-07
navify Digital Pathology (on-prem) v2.5, Material Number 100 Ventana Medical Systems, Inc.2026-08-07
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSW W L Gore & Associates, Inc.2026-08-07
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSW W L Gore & Associates, Inc.2026-08-07
Brand Name: Xhibit Product Name: Xhibit Central Station Mode Spacelabs Healthcare, Inc.2026-08-07
Boston Scientific Enhance Transcarotid/Peripheral Access Kit Galt Medical Corporation2026-08-07
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS- Covidien, LP2026-08-07
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLI Covidien, LP2026-08-07
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 Covidien, LP2026-08-07
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 Covidien, LP2026-08-07
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX Covidien, LP2026-08-07
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 1 Medline Industries, LP2026-08-07
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", Medline Industries, LP2026-08-07
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12" Medline Industries, LP2026-08-07
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12" Medline Industries, LP2026-08-07
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL Remel Europe Ltd.2026-08-07
Brand Name: U2 Total Knee System Product Name: Femoral offse United Orthopedic Corp.2026-08-06
Brand Name: U2 Total Knee System Product Name: Femoral offse United Orthopedic Corp.2026-08-06
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 0007740 Instrumentation Laboratory2026-08-06
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 0 Instrumentation Laboratory2026-08-06
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect TISSIUM SA2026-08-06
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT TISSIUM SA2026-08-06
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT TISSIUM SA2026-08-06
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT TISSIUM SA2026-08-06
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT TISSIUM SA2026-08-06
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT TISSIUM SA2026-08-06
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT TISSIUM SA2026-08-06
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT TISSIUM SA2026-08-06
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm Freudenberg Medical, LLC2026-08-06
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm Freudenberg Medical, LLC2026-08-06
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloo Contego Medical, Inc2026-08-06
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M36 Boston Scientific Neuromodulation Corporation2026-08-05
Brand Name: U2 Total Knee System Product Name: PSA Box Trial United Orthopedic Corp.2026-08-05
Brand Name: USTAR II Knee System Product Name: Hinge Box Tri United Orthopedic Corp.2026-08-05
Brand Name: U2 Total Knee System Product Name: Femoral valgu United Orthopedic Corp.2026-08-05
Brand Name: U2 Total Knee System Product Name: Femoral valgu United Orthopedic Corp.2026-08-05
HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AS Hardy Diagnostics2026-08-05
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), E Beckman Coulter Inc.2026-08-05
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit Beckman Coulter Inc.2026-08-05
Atellica CH Urine Albumin REF: 11537225 Siemens Healthcare Diagnostics, Inc.2026-08-05
Philips Allura under the following System Descriptions and c PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-05
Philips Azurion under the following System Descriptions and PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-05
Philips Allura, Cardio Vascular-Allura Centron. Model Number PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-05
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-4 Aniara Diagnostica LLC2026-08-05
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 Aniara Diagnostica LLC2026-08-05
5-PLASMA Bivalirudin Control, Model Number 5D-44905 Aniara Diagnostica LLC2026-08-05
Merge PACS, medical imaging diagnostic workstation Merge Healthcare, Inc.2026-08-04
Merge OrthoPACS, medical imaging diagnostic workstation Merge Healthcare, Inc.2026-08-04
GE Healthcare MAC VU360, REF# part number 2030361-023; Elect GE Medical Systems Information Technologies Inc2026-08-04
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: Biofire Defense2026-08-04

Get this in your inbox or your code

Paid plans receive weekly change alerts by email, and the /v1/changes API serves the same feed for automation.