Atlas FDA

FDA clearances & recalls - week 21, 2026

FDA cleared 58 devices through the 510(k) pathway in week 21 of 2026 (2026-05-26 to 2026-05-30), down 26% from the prior week's 78. Radiology led with 12 clearances. Average review time for the week's cohort was 165 days; the fastest decision was ANDI 2.2 (K261405) at 29 days. FDA also posted 45 device recalls.

58510(k) clearances
45recalls posted
165 daysaverage review, this cohort
-26%vs prior week

By specialty

Radiology (12)Orthopedic (11)General, Plastic Surgery (7)Anesthesiology (5)Gastroenterology, Urology (5)

Clearances (top 50 of 58)

DeviceApplicantSpecialtyDecidedReview days
CoLink® & CoLag® Non-Sterile Screws In2Bones USA, LLCOrthopedic2026-05-3052
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adul Philips Medizin Systeme Böblingen GmbHCardiovascular2026-05-29267
Peak Flow Meter (PF-10(BR-PEF231)) Shenzhen Bi-Rich Medical Devices Co., Ltd.Anesthesiology2026-05-29268
LASEmaR 1500 Eufoton S.R.L.General, Plastic Surgery2026-05-29105
Injection Needle Mirco-Tech (Nanjing) Co., Ltd.Gastroenterology, Urology2026-05-29121
Xpert PFP Newclip TechnicsOrthopedic2026-05-2960
Navigated LLIF Impactable Tracker Tyber Medical, LLCNeurology2026-05-2959
M12 Telemetry System Global Instrumentation, LLCCardiovascular2026-05-29266
HistoSonics® Planning Tool HistoSonics, Inc.Radiology2026-05-29256
CoSense ETCO Monitor Capnia, Inc.Anesthesiology2026-05-29247
Oxygen Concentrator (OX-5A, OX-5C) Oxytek Medical Technology Co., Ltd.Anesthesiology2026-05-29254
OrthoGrid Hip AI® 4.0 OrthoGrid Systems, Inc.Radiology2026-05-29137
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter K C.R. Bard, Inc.Gastroenterology, Urology2026-05-29162
Cryo Sport 2.0 (AVA 501) Avanutri Equipamentos DE SaúdePhysical Medicine2026-05-29302
ZEUS Platform (FG0501US) iRhythm Technologies, Inc.Cardiovascular2026-05-29262
GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) Cosmo Artificial Intelligence - Ai, Ltd.Gastroenterology, Urology2026-05-2932
Exceed® Biplanar Expandable Interbody System Spine Wave, Inc.Orthopedic2026-05-2951
LUNE PureHygiene Enamel PureGeneral, Plastic Surgery2026-05-29133
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003 Anker Innovations LimitedObstetrics/Gynecology2026-05-29149
Nexus DRF Digital X-ray Imaging System Varex Imaging CorporationRadiology2026-05-29247
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrog INTEROJO, Inc.Ophthalmic2026-05-29101
ENTire IRE System Entire Medical , Ltd.General, Plastic Surgery2026-05-2946
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD Bioptimal International Pte. , Ltd.Cardiovascular2026-05-28274
Arthrex Bioabsorbable PushLock Suture Anchors Arthrex, Inc.Orthopedic2026-05-28170
Ulike Clear Zero (YC10 BU) Guangxi Ulike Medical Technology Co., Ltd.Neurology2026-05-2871
Zimmer® Persona® Personalized Knee System Zimmer, Inc.Orthopedic2026-05-28346
STIMPOD NMS460 Nerve Stimulator Algiamed Technologies USA, Inc.Neurology2026-05-28274
Helio Kids; Apex P Motion CompositesPhysical Medicine2026-05-28119
780 nm SPY Portable Handheld Imaging (SPY-PHI) System Stryker EndoscopyRadiology2026-05-2859
Disposable Endoscopic Distal Attachments Yangzhou Fartley Medical Instrument Technology Co., Ltd.Gastroenterology, Urology2026-05-28108
BD BACTEC FXI Culture System BD Diagnostic SystemsMicrobiology2026-05-28125
Trexon™ Monofilament Synthetic Absorbable Suture MedtronicGeneral, Plastic Surgery2026-05-28196
BMD Titanium Spinal Fusion System Global Biomedica s.r.o.Orthopedic2026-05-28175
ANDI 2.2 Imeka Solutions, Inc.Radiology2026-05-2829
Bellalun 2D (VDMS-1000S) Vieworks Co., Ltd.Radiology2026-05-28160
Dukal Crepe Paper Sterilization Wrap Dukal, LLCGeneral Hospital2026-05-28266
Multimodality Simulation Workspace (MM Sim) (v1.0.0) Philips Medical Systems Nederland B.V.Radiology2026-05-27124
XR-Series (XR-10, XR-20) Automated Hematology Analyzers Sysmex America, Inc.Hematology2026-05-27240
RENASYS EDGE (66803126) Smith & Nephew Medical, Ltd.General, Plastic Surgery2026-05-2789
AQUA Laminoplasty Systems ZheJiang Decans Medical Devices Co., Ltd.Orthopedic2026-05-27254
StimelMD (SSMD) system Motion Informatics ltd.Physical Medicine2026-05-27127
Synapse Lung Nodule AI Fujifilm CorporationRadiology2026-05-27160
EPIQ Series Diagnostic Ultrasound System Philips Ultrasound, LLCRadiology2026-05-27132
ResScan Essentials Resmed CorpAnesthesiology2026-05-27159
Dione PEEK Screw System ZheJiang Decans Medical Devices Co., Ltd.Orthopedic2026-05-27244
Glucommander Glytec, LLCAnesthesiology2026-05-27159
LigaPASS™ System Medicrea International S.A.SOrthopedic2026-05-2730
Helion Viewer Suite Videomed Srl ( a Baxter Healthcare Corp company)Radiology2026-05-27148
Visby Medical Flu and COVID-19 Test Visby Medical, Inc.Microbiology2026-05-27167
Portable Dental X-ray System Model PDX nova PDX Co., Ltd.Dental2026-05-27112

Recalls posted

ProductRecalling firmPosted
Ivenix Infusion System (IIS), Large Volume Pump, Model Numbe Fresenius Kabi USA, LLC2026-05-29
BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocain Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocain Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocain Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocai Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocai Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuinc Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocai Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocai Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocai Becton Dickinson & Company2026-05-29
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocai Becton Dickinson & Company2026-05-29
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula Covidien LLC2026-05-29
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inl Baxter Healthcare Corporation2026-05-29
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSID B Braun Medical Inc2026-05-29
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJ B Braun Medical Inc2026-05-29
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL B Braun Medical Inc2026-05-29
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS B Braun Medical Inc2026-05-29
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOH B Braun Medical Inc2026-05-29
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSI B Braun Medical Inc2026-05-29
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS B Braun Medical Inc2026-05-29
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DO B Braun Medical Inc2026-05-29
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Covidien LLC2026-05-29
Covidien Mon-a-Therm General Purpose Temperature Probe REF: Covidien LLC2026-05-29
Covidien Mon-a-Therm general purpose temperature probe size: Covidien LLC2026-05-29
The Large Volume Pump (LVP) of the Ivenix Infusion System (I Fresenius Kabi USA, LLC2026-05-29
Medline kits containing Huons Co. Bupivacaine HCL in Dextros Medline Industries, LP2026-05-28
Medline kits containing Huons Co. Bupivacaine HCL in Dextros Medline Industries, LP2026-05-28
Medline kits containing Huons Co. Bupivacaine HCL in Dextros Medline Industries, LP2026-05-28
Medline kits containing Huons Co. Bupivacaine HCL in Dextros Medline Industries, LP2026-05-28
Medline kits containing Huons Co. Bupivacaine HCL in Dextros Medline Industries, LP2026-05-28
Medline kits containing Huons Co. Bupivacaine HCL in Dextros Medline Industries, LP2026-05-28
Medline kits containing Huons Co. Bupivacaine HCL in Dextros Medline Industries, LP2026-05-28
Automated Impella Controller (AIC) with the below product de Abiomed, Inc.2026-05-28
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Medtronic Neuromodulation2026-05-28
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Medtronic Neuromodulation2026-05-28
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF # GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Rec GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, R GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH A GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L GE Medical Systems Information Technologies Inc2026-05-28
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, GE Medical Systems Information Technologies Inc2026-05-28
Azurion system; System Code Description (Model Numbers): Azu PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-28
Allura system; System Code Description (Model Numbers): Allu PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-28
Medline medical convenience kit labeled as EYE TRAY-LF, Medl Medline Industries, LP2026-05-28
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-1 Devicor Medical Products Inc2026-05-27

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