Atlas FDA

FDA clearances & recalls - week 18, 2026

FDA cleared 48 devices through the 510(k) pathway in week 18 of 2026 (2026-05-04 to 2026-05-09), down 32% from the prior week's 71. Orthopedic led with 10 clearances. Average review time for the week's cohort was 151 days; the fastest decision was AccelFix Spinal Fixation System (K261130) at 29 days. FDA also posted 50 device recalls.

48510(k) clearances
50recalls posted
151 daysaverage review, this cohort
-32%vs prior week

By specialty

Orthopedic (10)General, Plastic Surgery (9)Radiology (6)Neurology (5)Dental (4)

Clearances

DeviceApplicantSpecialtyDecidedReview days
aprevo® anterior and lateral lumbar interbody system; aprevo Carlsmed, Inc.Orthopedic2026-05-0992
Avanti Distal Elbow ORIF System Avanti Orthopaedics, LLCOrthopedic2026-05-0932
Hydro Irrigation System Stryker InstrumentsNeurology2026-05-08168
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm Elde Medikal Sanayi ve Ticaret Anonim SirketiNeurology2026-05-08221
Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SS Zeus ScientificImmunology2026-05-08417
AYON Body Contouring System™ (AYON SYSTEM) Apyx Medical CorporationGeneral, Plastic Surgery2026-05-08220
HipGuide (V 1.0.0.0) Orthopedic Driven Imaging, LLCRadiology2026-05-0898
Modius Spero Neurovalens LimitedNeurology2026-05-08387
Arthrex Beaming System Arthrex, Inc.Orthopedic2026-05-08130
Disposable Stone Retrieval Balloon Catheter Zhejiang Soudon Medical Technology Co., Ltd.Gastroenterology, Urology2026-05-08231
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening Sy Orthofix SrlOrthopedic2026-05-08147
MiroCam® Capsule Endoscope System Intromedic Co., Ltd.Gastroenterology, Urology2026-05-08262
LingOral Dental Design System Hangzhou ChohoTech Co., Ltd.Dental2026-05-0888
DeepSkin (DEP100) El Global Trade, Ltd.Neurology2026-05-08262
Smylio Aligners Smylio, Inc.Dental2026-05-0859
AerFrame Patient Immobilization System (AFPIS) Stabilix, LLCRadiology2026-05-0858
Neodent Gold Hue Custom Abutments, Medentika Custom Abutment Institut Straumann AGDental2026-05-0785
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module Heidelberg Engineering GmbHOphthalmic2026-05-07157
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilizat Globus Medical, Inc.Orthopedic2026-05-07164
MR Conditional Cup Electrodes Technomed EuropeNeurology2026-05-07135
Lynx Aspiration Catheter System Q’Apel Medical, Inc.Cardiovascular2026-05-07128
Evita (V800); Evita (V600) Draegerwerk AG & CO KgaaAnesthesiology2026-05-07168
Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Galvanize Therapeutics, Inc.General, Plastic Surgery2026-05-07157
Veritas Reverse Total Shoulder System Restor3DOrthopedic2026-05-07146
CO2 Laser Machine (Monica-I,Monica-II) Nanjing Bestview Laser S&T Co., Ltd.General, Plastic Surgery2026-05-0744
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP100 Biozen, LLCCardiovascular2026-05-06222
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD Shenzhen Changkun Technology Co., Ltd.Gastroenterology, Urology2026-05-06266
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff Nihon Kohden CorporationCardiovascular2026-05-0661
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ Teleflex Medical, LLCGeneral, Plastic Surgery2026-05-0657
Anchor with Fiber Wire and Disposable Inserter Ortobio S.A.Orthopedic2026-05-06229
CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd.Orthopedic2026-05-0633
KardiaPSI Balloon Catheter Intervention Tech, Inc. ; dba CorventionCardiovascular2026-05-06154
Denture Base Shandong Huge Dental Material CorporationDental2026-05-0690
Healium Intelliscan LX192LC Healium Intelliscan CorporationRadiology2026-05-0529
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003 Wenzhou Lingfeng Electronic Technology Co., Ltd.Physical Medicine2026-05-05127
MectaLIF 3D Metal Anterior Medacta International S.A.Orthopedic2026-05-05127
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI2 Shenzhen Ulike Smart Electronics Co., Ltd.General, Plastic Surgery2026-05-0560
AccelFix Spinal Fixation System L&K BIOMED Co., Ltd.Orthopedic2026-05-0529
Lumify Diagnostic Ultrasound System Philips Ultrasound, LLCRadiology2026-05-05265
Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810 Leaseir Technologies, SluGeneral, Plastic Surgery2026-05-04217
Wound Geni NPWT System Bechtel Medical, Inc.General, Plastic Surgery2026-05-04140
MammoSightAI Neurocareai, Inc. (Dba Savelife.Ai)Radiology2026-05-04230
Neowise Cefla S.C.Radiology2026-05-0460
Q-Switched Nd: YAG Laser Systems Shanghai Apolo Medical Technology Co., Ltd.General, Plastic Surgery2026-05-0496
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, B Amsino International, Inc.General Hospital2026-05-04265
ArteraAI Breast Artera, Inc.Pathology2026-05-04136
Male Latex Condom HA Okamoto USA, Inc.Obstetrics/Gynecology2026-05-04258
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY- Shenzhen Kaiyan Medical Equipment Co., Ltd.General, Plastic Surgery2026-05-0462

Recalls posted

ProductRecalling firmPosted
Custom Convenience Kit containing recalled Medline Namic Ang Windstone Medical Packaging, Inc.2026-05-08
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: O On-X Life Technologies, Inc.2026-05-08
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/C DJO, LLC2026-05-08
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH M DJO, LLC2026-05-08
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH M DJO, LLC2026-05-08
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH M DJO, LLC2026-05-08
Namic Angiographic Manifold, custom, Medline Product Number/ Medline Industries, LP2026-05-08
Namic Angiographic Manifold, custom, Medline Product Number/ Medline Industries, LP2026-05-08
Namic Angiographic Manifold, custom, Medline Product Number/ Medline Industries, LP2026-05-08
Namic Preceptor Manifold, custom, Medline Product Number/SKU Medline Industries, LP2026-05-08
Namic Preceptor Manifold, custom, Medline Product Number/SKU Medline Industries, LP2026-05-08
Medline medical convenience kits, containing Namic Manifold, Medline Industries, LP2026-05-08
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. M Medline Industries, LP2026-05-08
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V Medline Industries, LP2026-05-08
Medline medical convenience kits, containing Namic Manifold, Medline Industries, LP2026-05-08
Medline medical convenience kits, containing Namic Manifold, Medline Industries, LP2026-05-08
Medline medical convenience kits, containing Namic Manifold, Medline Industries, LP2026-05-08
Revolution Ascend, computed tomography, Model Numbers 696900 GE Medical Systems, LLC2026-05-08
Revolution CT, x-ray computed tomography, Model Numbers 5590 GE Medical Systems, LLC2026-05-08
Revolution Apex Elite, X-ray Computed Tomography, Model Numb GE Medical Systems, LLC2026-05-08
Revolution Apex Plus, X-ray Computed Tomography, Model Numbe GE Medical Systems, LLC2026-05-08
Revolution CT ES, X-ray Computed Tomography, Model Number 55 GE Medical Systems, LLC2026-05-08
Revolution Apex, X-ray Computed Tomography, Model Number 559 GE Medical Systems, LLC2026-05-08
Revolution Apex Select, X-ray Computed Tomography, Model Num GE Medical Systems, LLC2026-05-08
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Num Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Num Medline Industries, LP2026-05-07
See RES for complete list. Medline Convenience Kits: 1) OPEN Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00 Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, M Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL Medline Industries, LP2026-05-07
See RES for full list. Medline Convenience Kits: 1) CHP COCH Medline Industries, LP2026-05-07
See RES for complete list. Medline Convenience Kits: 1) MAJO Medline Industries, LP2026-05-07
See RES for complete list. Medline Convenience Kits: 1) PLAS Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: D Medline Industries, LP2026-05-07
See RES for complete list. Medline Convenience Kits: 1) DRAW Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500 Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK10119 Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA13 Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Mode Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Numb Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; Medline Industries, LP2026-05-07
See full list in RES, exceeds character limit 1) GYN LAPAROS Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: C Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Medline Industries, LP2026-05-07
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, M Medline Industries, LP2026-05-07
See RES for complete list. Medline Convenience Kits: 1) SPIN Medline Industries, LP2026-05-07

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