Atlas FDA

FDA clearances & recalls - week 23, 2026

FDA cleared 75 devices through the 510(k) pathway in week 23 of 2026 (2026-06-08 to 2026-06-13), up 0% from the prior week's 75. Radiology led with 10 clearances. Average review time for the week's cohort was 169 days; the fastest decision was ERBECRYO 2 Cryosurgical Unit and Accessories (K261806) at 8 days. FDA also posted 50 device recalls.

75510(k) clearances
50recalls posted
169 daysaverage review, this cohort
+0%vs prior week

By specialty

Radiology (10)Cardiovascular (9)Orthopedic (9)General, Plastic Surgery (8)Physical Medicine (6)

Clearances (top 50 of 75)

DeviceApplicantSpecialtyDecidedReview days
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx ( Neuroelectrics Barcelona S.L.U.Neurology2026-06-1330
Fast PCR Mini Respiratory Panel Autonomous Medical Devices IncorporatedMicrobiology2026-06-12270
Disposable Blood Lancet (Soft) SteriLance Medical (Suzhou), Inc.General, Plastic Surgery2026-06-1225
ThinkQA 3 Dosisoft SARadiology2026-06-12270
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH8 Polybell (Guangzhou) LimitedObstetrics/Gynecology2026-06-12129
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-02 Midmark CorporationCardiovascular2026-06-12259
Exalta Proximal Tibia Plating System Tyber Medical, LLCOrthopedic2026-06-1260
Tornier Perform Reversed Glenoid and Tornier Perform Reverse Stryker Corporation (Tornier, Inc.)Orthopedic2026-06-12150
cobas pulse blood glucose monitoring system Roche DiagnosticsClinical Chemistry2026-06-12322
MEDRAD® Imaging Bulk Package Transfer Spike Bayer Medical Care, Inc.General Hospital2026-06-12203
Profoject™ Safety Needle; Profoject™ Syringe with Safety Nee CMT Health PTE., Ltd.General Hospital2026-06-12115
Medical Monitor (40HT513D) Lg Electronics.IncRadiology2026-06-1259
ADRx™ Admixture Device Epic Medical Pte. , Ltd.General Hospital2026-06-12267
DYNE PORT Dyne Medical Group, Inc.Gastroenterology, Urology2026-06-12270
OneStim-DUO Cardiac Stimulator (MP5003-4CO) Micropace Pty, Ltd.Cardiovascular2026-06-12262
HARBOR Occlusion Device Nuvascular, Inc.Cardiovascular2026-06-12106
Brainomix 360 Hyperdensity Brainomix LimitedRadiology2026-06-12123
Barbed PDO Suture Sutura Medical Technology, Inc.General, Plastic Surgery2026-06-12337
Universal 1417PI Konica Minolta Healthcare Americas, Inc.Radiology2026-06-12267
Spiro-VISTA Spiro RoboticsAnesthesiology2026-06-12254
Cognitive Function Neuroimaging (cfNI) Software (1.0.0) VoxNeuro, Inc.Neurology2026-06-12266
Stelo Glucose Biosensor System Dexcom, Inc.Clinical Chemistry2026-06-1284
BTL-899TT BTL Industries, Inc.Physical Medicine2026-06-12268
WHILL (WHILL Model C2) Whill, Inc.Physical Medicine2026-06-1263
Virtus Somnomed, Inc.Dental2026-06-1246
Intense Pulsed Light Therapy Device Sanhe LEFIS Electronics Co., Ltd.General, Plastic Surgery2026-06-1260
UNEEG EpiSight System Uneeg Medical A/SNeurology2026-06-11205
Fluoride Varnish (Type A,Type C) Nagy Oral Technology Qinhuangdao Co., Ltd.Dental2026-06-11262
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShiel FloShield, Inc.Gastroenterology, Urology2026-06-1199
Snorbliss® Anti-Snoring Device Endeavor Commerce, LLCDental2026-06-1156
Respiration Rate algorithm Edwards Lifesciences, LLCAnesthesiology2026-06-11408
i-STAT hs-TnI cartridge with the i-STAT Alinity System Abbott Point of Care, Inc.Clinical Chemistry2026-06-11262
ICON 35; ICON 45; ICON 60; ICON 30FAF Rehasense USA, Inc.Physical Medicine2026-06-1187
Verge™ Microcatheter Instylla, Inc.Cardiovascular2026-06-1128
Ion-L SurGenTec, LLCUnknown2026-06-1159
PROBEAT-CR Hitachi High-Tech Corp.Radiology2026-06-11141
Omni-Directional Multi-Unit Abutment System (Trade Name: Omn Smart Denture Conversions, LLCDental2026-06-11171
AViTA Breast Pump Avita CorporationObstetrics/Gynecology2026-06-11510
Dental X-ray System Changzhou Boen Zhongding Medical Technology Co., Ltd.Radiology2026-06-11448
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-A Shenzhen Magnet Technology Co., Ltd.Ear, Nose, Throat2026-06-1156
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction Sy Synthes (USA) Products, LLCOrthopedic2026-06-11175
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Pe PR Personal Care LaboratoriesObstetrics/Gynecology2026-06-1152
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak MedicalRadiology2026-06-11132
Anura Mobile Core SDK (M1) Nuralogix CorporationCardiovascular2026-06-11203
Rosetta SM, Rosetta SP Hass Corp.Dental2026-06-1187
Dexter L6 System Distalmotion SAGeneral, Plastic Surgery2026-06-11104
DeepXray Spina Alpha Intelligence Manifolds, Inc.Radiology2026-06-10257
LARS ACJ Movmedix S.A.S.Orthopedic2026-06-10259
Tinnitus Therapy Sivantos GmbHEar, Nose, Throat2026-06-10105
MSS - Humeral reverse liners extension Medacta International, SAOrthopedic2026-06-1075

Recalls posted

ProductRecalling firmPosted
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/AS ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-A ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PS ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-4 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; R ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC- ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-1 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703- ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802- ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-0451 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPK ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-4155 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK- ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-0160 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK- ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PARACENTESIS KIT/ASK-00376-JHH ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK- ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SA ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: ACCESS TRAY/ASK-04001-MC3 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-0203 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L ARROW INTERNATIONAL, LLC2026-06-13
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; R ARROW INTERNATIONAL, LLC2026-06-13
Automated Impella Controller (AIC), for use with left heart Abiomed, Inc.2026-06-12
Medline EBSI Kit EBSI1534 Medline Industries, LP2026-06-12
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2 Medline Industries, LP2026-06-12
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A Medline Industries, LP2026-06-12
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47 Medline Industries, LP2026-06-12
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CD Medline Industries, LP2026-06-12
Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYND Medline Industries, LP2026-06-12
Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS98485 Medline Industries, LP2026-06-12
Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYN Medline Industries, LP2026-06-12
Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ Medline Industries, LP2026-06-12
Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLAS Medline Industries, LP2026-06-12
Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ6 Medline Industries, LP2026-06-12
Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662 Medline Industries, LP2026-06-12
Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359 Medline Industries, LP2026-06-12
Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D Medline Industries, LP2026-06-12

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