Atlas FDA

FDA clearances & recalls - week 27, 2026

FDA cleared 52 devices through the 510(k) pathway in week 27 of 2026 (2026-07-06 to 2026-07-10), up 2% from the prior week's 51. Radiology led with 9 clearances. Average review time for the week's cohort was 122 days; the fastest decision was Denture Base Resin V2 (K262300) at 1 days. FDA also posted 50 device recalls.

52510(k) clearances
50recalls posted
122 daysaverage review, this cohort
+2%vs prior week

By specialty

Radiology (9)Orthopedic (7)Cardiovascular (7)General, Plastic Surgery (6)Microbiology (4)

Clearances (top 50 of 52)

DeviceApplicantSpecialtyDecidedReview days
Avara Viewer Avara SoftwareRadiology2026-07-1017
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series Howmedica Osteonics Corp., Dba Stryker OrthopaedicsOrthopedic2026-07-1056
Flowflex Plus RSV + Flu A/B + COVID Rapid Test ACON Laboratories, Inc.Microbiology2026-07-1087
SmartCT (R3.0 (L10)) Philips Medical Systems B.V.Radiology2026-07-10231
Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Cochlear AmericasEar, Nose, Throat2026-07-10114
ClearSafe Closed System MedSource Labs, LLCGeneral Hospital2026-07-10101
NYES Tuff Cuff L3 Disposable Gowns New York Embroidery StudioGeneral, Plastic Surgery2026-07-1029
SedLine Sedation Monitor Masimo CorporationNeurology2026-07-10115
LungFlow Airway Catheter Free Flow Medical, Inc.Ear, Nose, Throat2026-07-10206
AI Contouring (VA10A) Varian Medical SystemsRadiology2026-07-1081
POSEIDON ST Signus Medinzintechnik GmbHOrthopedic2026-07-10102
WallFlex Esophageal Stent System;Agile Esophageal Over-the-W Boston Scientific CorporationGeneral, Plastic Surgery2026-07-1028
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 Fre C.R. Bard, Inc.Gastroenterology, Urology2026-07-10246
Sofia Lyme FIA; Sofia 2 Campylobacter FIA Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)Microbiology2026-07-10191
Capenergy C Equipments RF C200 and C400 Drakarian Capenergy Medical S.L.General, Plastic Surgery2026-07-10269
Electric Wheelchair (DY611A-2, DY612A-1) Zhejiang Lumbre Electric Appliance Co., Ltd.Physical Medicine2026-07-1093
HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYD Procept BioroboticsGeneral, Plastic Surgery2026-07-09126
Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Teleflex Medical, LLCGeneral, Plastic Surgery2026-07-0927
Zeta TMS Navigation System Zeta Surgical, Inc.Neurology2026-07-0966
Millipede88 Access Catheter Perfuze, Ltd.Cardiovascular2026-07-09216
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knot Smith & Nephew, Inc.Orthopedic2026-07-0928
MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ MedSource Labs, LLCGeneral Hospital2026-07-09142
PINKSLIP Water-Based Personal Lubricant and Moisturizer PINKSLIP, LLCObstetrics/Gynecology2026-07-0990
UbiqVue™ 2AYe Cardiac System (UX2253) Lifesignals, Inc.Cardiovascular2026-07-0958
SmartGuard Technology; Predictive Low Glucose Technology Medtronic MiniMedClinical Chemistry2026-07-0928
ScioCardio ECG Analysis Platform Synergen Technology Labs, LLCCardiovascular2026-07-09295
3D-Anywhere Provect.AIRadiology2026-07-09216
DIA-CEM DiaDent Group InternationalDental2026-07-0991
LifeLens Physiological Monitor LifeLens Technologies, Inc.Cardiovascular2026-07-09170
CXRDetectAI Neurocareai, Inc. (Dba Savelife.Ai)Radiology2026-07-08225
Alians Elbow S Newclip TechnicsOrthopedic2026-07-0886
BlueDop Vascular Expert BlueDop Medical, Ltd.Cardiovascular2026-07-08126
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cob Roche Molecular Systems, Inc.Microbiology2026-07-08111
Denture Base Resin V2 Formlabs Ohio, Inc.Dental2026-07-081
ThermAffyx(TM) Patient Safety System Stihler Electronic GmbHCardiovascular2026-07-08160
C.A. Medical Interbody Fusion System C.A. Medical, LLCOrthopedic2026-07-08198
Electric Wheelchair Ningbo Resshidi Medical Devices Co., Ltd.Physical Medicine2026-07-0870
Virtual Cone (1.0) Varian Medical Systems, Inc.Radiology2026-07-08124
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System bioMerieux, Inc.Microbiology2026-07-08169
Luja Soft Coloplast A.S.Gastroenterology, Urology2026-07-0720
Electric wheelchair (XW-LY007 ) Yongkang Ruihe Metal Product Co., Ltd.Physical Medicine2026-07-0789
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact L HOYA Lamphun , Ltd.Ophthalmic2026-07-0736
Pulmonex II Xenon System (132-503) Mirion Technologies (Capintec), Inc.Radiology2026-07-07210
InferOperate Suite Beijing Infervision Healthcare Medical Technology Co., Ltd.Radiology2026-07-07105
Mobility Scooter (R200) Yongkang Ruihe Metal Product Co., Ltd.Physical Medicine2026-07-0789
Cytrans™ Elashield GC America, Inc.Dental2026-07-06279
TESSA Spatial Surgery System; INTELLIO Tablet (72205455) Smith & Nephew, Inc.Orthopedic2026-07-06318
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) SteriLance Medical (Suzhou), Inc.General, Plastic Surgery2026-07-06172
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories PCCA, Inc.Obstetrics/Gynecology2026-07-0628
MobileLink Acetabular Cup System – 40mm ID Inserts (various) Waldemar Link GmbH & Co. KGOrthopedic2026-07-06102

Recalls posted

ProductRecalling firmPosted
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostati Oscor Inc.2026-07-10
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostati Oscor Inc.2026-07-10
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostati Oscor Inc.2026-07-10
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code Abiomed, Inc.2026-07-10
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing Abiomed, Inc.2026-07-10
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Abiomed, Inc.2026-07-10
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, Abiomed, Inc.2026-07-10
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Cod Abiomed, Inc.2026-07-10
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Cod Abiomed, Inc.2026-07-10
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 100 Abiomed, Inc.2026-07-10
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1 Abiomed, Inc.2026-07-10
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Abiomed, Inc.2026-07-10
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048- Abiomed, Inc.2026-07-10
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Abiomed, Inc.2026-07-10
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; Abiomed, Inc.2026-07-10
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set C Abiomed, Inc.2026-07-10
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Argon Medical Devices, Inc2026-07-10
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascula Argon Medical Devices, Inc2026-07-10
General Biospy Tray, REF: GUTS1000 Argon Medical Devices, Inc2026-07-10
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104 Argon Medical Devices, Inc2026-07-10
Arterial Line Kit 20ga x 6, REF: 400115A Argon Medical Devices, Inc2026-07-10
Bone Marrow Tray, REF: CB0033TL; CB0355TLA Argon Medical Devices, Inc2026-07-10
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 18 Olympus Corporation of the Americas2026-07-10
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 18 Olympus Corporation of the Americas2026-07-10
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Olympus Corporation of the Americas2026-07-10
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 19 Olympus Corporation of the Americas2026-07-10
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 4 Intuitive Surgical, Inc.2026-07-10
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 4 ICU Medical, Inc.2026-07-10
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number ICU Medical, Inc.2026-07-10
Rapid Refill Continuous Injection System, UPN M00566001 Boston Scientific Corporation2026-07-10
Brand Name: Fletcher CT/MR Shielded Applicator Set Product N Elekta, Inc.2026-07-09
Brand Name: Brachytherapy Applicator Product Name: Advanced Elekta, Inc.2026-07-09
Brand Name: Geneva Product Name: Brachytherapy Applicator Pr Elekta, Inc.2026-07-09
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. WALLAC OY2026-07-09
OmniTract Surgical Retractor System, which includes 633 of t Integra LifeSciences Corp. (NeuroSciences)2026-07-09
VITEK 2 AST-N447 TEST KIT Product reference 424620 Biomerieux Inc2026-07-09
TMINI Femur Tracking Array REF 109003 UDI-DI code: M94610900 Think Surgical, Inc.2026-07-09
Brand Name: Versius Surgical System US Product Name: Vesius CMR SURGICAL LIMITED2026-07-09
Intracept Access Instruments, Description/REF: INTRACEPT ACC Boston Scientific Neuromodulation Corporation2026-07-08
Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Mode Medline Industries, LP2026-07-08
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Num Medline Industries, LP2026-07-08
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Num Medline Industries, LP2026-07-08
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895 Medtronic MiniMed, Inc.2026-07-08
KL Owen Custom Orthodontic Solution, model/catalog number CI Klowen Braces2026-07-08
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, Encore Medical, LP2026-07-08
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, Encore Medical, LP2026-07-08
5008X Blood Tubing Set, 24 units per case. Includes the belo Fresenius Medical Care Holdings, Inc.2026-07-08
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Numbe Siemens Healthcare Diagnostics, Inc.2026-07-08
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Us Olympus Corporation of the Americas2026-07-07
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in ConvaTec, Inc2026-07-07

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