Atlas FDA

FDA clearances & recalls - week 24, 2026

FDA cleared 89 devices through the 510(k) pathway in week 24 of 2026 (2026-06-15 to 2026-06-20), up 19% from the prior week's 75. Radiology led with 15 clearances. Average review time for the week's cohort was 179 days; the fastest decision was NEUROMARK System (NMK00301) (K261833) at 14 days. FDA also posted 50 device recalls.

89510(k) clearances
50recalls posted
179 daysaverage review, this cohort
+19%vs prior week

By specialty

Radiology (15)Orthopedic (14)Dental (8)Cardiovascular (7)General, Plastic Surgery (7)

Clearances (top 50 of 89)

DeviceApplicantSpecialtyDecidedReview days
Dynamis Robotic Surgical System LEM Surgical AGNeurology2026-06-20135
Powder Free Nitrile Examination Gloves Non-Sterile Black Kanglongda Vietnam Protection Technology Company LimitedGeneral Hospital2026-06-18199
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syring Sol-Millennium Medical, Inc.General Hospital2026-06-18267
MEMO 4D Curve™ Semirigid mitral annuloplasty ring Corcym S.r.l.Cardiovascular2026-06-1827
ZywieZ3 Sensor & Adhesive Zywie, Inc.Cardiovascular2026-06-18286
Syncron-E Autonomous Healthcare, Inc.Anesthesiology2026-06-18360
SteriBest® Sterilization Tray System Mastel SurgicalGeneral Hospital2026-06-18265
SmartSpectra Vital Signs Monitor 1.0 Presage Security, Inc. d/b/a Presage Technologies, Inc.Cardiovascular2026-06-18177
Blood Volume Analyzer (200) Daxor CorporationHematology2026-06-1877
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03B Guangdong Newdermo Biotech Co., Ltd.General, Plastic Surgery2026-06-1887
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40- Micro-Energy Medical Technology Co., Ltd.General, Plastic Surgery2026-06-1827
CORUS™ Navigation System-GN Providence Medical Technology, Inc.Neurology2026-06-1829
CONDUIT™ ZERO-P™ VA Secured Spacer System Avalign Technologies, Inc.Orthopedic2026-06-18274
Power Wheelchair (W5915B, W5915C, W5915D) Zhejiang Innuovo Rehabilitation Devices Co.,LtdPhysical Medicine2026-06-18202
ARTHUR ROPCA ApSRadiology2026-06-18147
Curing Light (M-Cure 6) Guangzhou Rebornendo Medical Instrument Co., Ltd.Dental2026-06-18266
InstaTRU Instant Biological Indicator for Steam (IBI-05) True Indicating, LLCGeneral Hospital2026-06-18393
inspired™ Heated Breathing Circuit (510-008); inspired™ Heat Vincent Healthcare Products LimitedAnesthesiology2026-06-18352
3D MAC Titanium Cranial Plate (TCP) System The Surgeon General, Department of the Army (TSG-DA)Neurology2026-06-18267
RadOncAI InformaiRadiology2026-06-18269
MegaGen Zygoma Dental Implant System Megagen Implant Co., Ltd.Dental2026-06-18422
Portable DR Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd.Radiology2026-06-18269
ECMT-100 WMD Ecm Therapeutics, Inc.Unknown2026-06-18217
Pelvic Muscle Trainer (KM510, KM516B) Shenzhen Konmed Technology Co., Ltd.Gastroenterology, Urology2026-06-18148
NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Tri Hycor BiomedicalImmunology2026-06-18140
VIVIX-S 4386W (FXRD-4386WA) Vieworks Co., Ltd.Radiology2026-06-1897
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Witho Stryker Sustainability SolutionsGeneral, Plastic Surgery2026-06-18112
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311 Shenzhen Root Innovation Technology Co., Ltd.Obstetrics/Gynecology2026-06-18171
Wrist Blood Pressure Monitor (XW-05) Shenzhen Ziqing Medical Equipment Co., Ltd.Cardiovascular2026-06-18266
Vascular Assist Occlusion Triage (VAOT) (v1.0) GuideAI HealthRadiology2026-06-18104
Implantmed Plus II & Piezomed Plus II Module W&H Dentalwerk Buermoos GmbHDental2026-06-18204
Synapse PACS (7.6.0) FUJIFILM Healthcare Americas CorporationRadiology2026-06-1827
SRGC-06 GC America, Inc.Dental2026-06-1863
MAMMOMAT B.brilliant (11372950) Siemens Medical Solutions USA, Inc.Radiology2026-06-18209
Dental Implant System A.B. Dental Devices , Ltd.Dental2026-06-18458
Precice™ Max System and Precice™ Ankle Salvage System NuVasive Specialized OrthopedicsOrthopedic2026-06-1830
AND Medical Femoral Nail System (PFNA01); AND Medical Femora Suzhou and Science & Technology Development Corp.Orthopedic2026-06-18268
PICOSURE WORKSTATION Cynosure, LLCGeneral, Plastic Surgery2026-06-1736
INOSS System Inosys, Inc.Dental2026-06-17166
Nitrile Powder Free Examination Gloves Tested for Use with C Hartalega NGC Sdn. Bhd.General Hospital2026-06-1792
Hydro Irrigation System Stryker InstrumentsEar, Nose, Throat2026-06-1740
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420 Shenzhen Root Innovation Technology Co., Ltd.Obstetrics/Gynecology2026-06-17120
Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Nordic Kinetics ABNeurology2026-06-17268
FLEXI-PORT™ Power Injectable Implantable Port Portal Access, Inc.General Hospital2026-06-1790
twiist Automated Insulin Delivery (AID) System Deka Research and DevelopmentClinical Chemistry2026-06-1727
“Socko” Vimax Spinal Fixation System Socko Medical Co., Ltd.Orthopedic2026-06-17268
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel Foshan Pingchuang Medical Technology Co., Ltd.Radiology2026-06-17261
Fule Metallic Lockable Intramedullary Nail Systems Beijing Fule Science & Technology Development Co., Ltd.Orthopedic2026-06-17264
Amplatzer TorqVue Exchange System Abbott MedicalCardiovascular2026-06-1730
Bonvadis® Oneness Biotech Co., Ltd.Unknown2026-06-1730

Recalls posted

ProductRecalling firmPosted
Giraffe Stand-alone Infant Resuscitation System; Powered eme Datex-Ohmeda Inc2026-06-18
Giraffe Warmer with Integrated Resuscitation System (iRes), Datex-Ohmeda Inc2026-06-18
Panda Freestanding Warmer, Infant Radiant Warmer Product Ide Datex-Ohmeda Inc2026-06-18
Impella CP Set with SmartAssist. Product Codes: 1000080, 100 Abiomed, Inc.2026-06-18
Product Name: STAAR ICL Calculation Software Software Versio Staar Surgical AG2026-06-18
iLet Bionic Pancreas, REF: BB1001 Beta Bionics, Inc.2026-06-18
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 003829 BD SWITZERLAND SARL2026-06-18
Brand Name: Inspire Medical Systems, Inc. Product Name: Insp Inspire Medical Systems Inc.2026-06-18
Brand Name: Inspire Medical Systems, Inc. Product Name: Insp Inspire Medical Systems Inc.2026-06-18
Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI Merit Medical Systems, Inc.2026-06-18
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventric Thoratec LLC2026-06-18
Brand Name: HeartMate Product Name: HeartMate 3" System Cont Thoratec LLC2026-06-18
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Bat Thoratec LLC2026-06-18
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. Howmedica Osteonics Corp.2026-06-17
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. Howmedica Osteonics Corp.2026-06-17
ConMed AirSeal 5 mm Smooth Access Port and Obturator with Bl ConMed Corporation2026-06-17
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Ti ConMed Corporation2026-06-17
ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip ConMed Corporation2026-06-17
ConMed AirSeal 8mm Access Port and Low Profile Obturator wit ConMed Corporation2026-06-17
ConMed AirSeal 8mm Access Port and Low Profile Obturator wit ConMed Corporation2026-06-17
ConMed AirSeal 5mm Access Port and Low Profile Obturator wit ConMed Corporation2026-06-17
ConMed AirSeal 5mm Access Port and Low Profile Obturator wit ConMed Corporation2026-06-17
ConMed AirSeal 5mm Access Port and Low Profile Obturator wit ConMed Corporation2026-06-17
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with ConMed Corporation2026-06-17
ConMed AirSeal 12mm Access Port and Low Profile Obturator wi ConMed Corporation2026-06-17
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with ConMed Corporation2026-06-17
Giraffe OmniBed, a combination of an infant incubator and an GE Medical Systems, LLC2026-06-17
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation GE Medical Systems, LLC2026-06-17
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers GE Medical Systems, LLC2026-06-17
Mito Red Light, Super Mobile MITO RED LIGHT INC2026-06-17
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Medline Industries, LP2026-06-17
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Med Medline Industries, LP2026-06-17
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Medline Industries, LP2026-06-17
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber La Medline Industries, LP2026-06-17
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to C Medline Industries, LP2026-06-17
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to C Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBI Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PA Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADU Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, M Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASEC Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOM Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORAT Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY UR Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BAS Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT Medline Industries, LP2026-06-17
MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Med Medline Industries, LP2026-06-17

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