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Recently FDA-cleared medical devices

Every device we hold with a US FDA 510(k) clearance decided in the last 12 months, newest first. Each one links through to its full regulatory record.

3,665 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
Hive™ Standalone Cervical System and Hive™ C Interbody System

NanoHive Medical, LLC

Cleared 2026-02-13

Registered with
  • US (FDA)
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

Medinice S.A.

Cleared 2026-02-13

Registered with
  • US (FDA)
DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

Alcon Laboratories

Cleared 2026-02-13

Registered with
  • US (FDA)
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)

Joytech Healthcare Co. , Ltd.

Cleared 2026-02-13

Registered with
  • US (FDA)
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)

Bayer Medical Care Inc

Cleared 2026-02-13

Registered with
  • US (FDA)
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

Shenzhen Best Electronics Co.,Ltd

Cleared 2026-02-13

Registered with
  • US (FDA)
Wearable Breast Pump (Model W12)

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2026-02-13

Registered with
  • US (FDA)
PreemptiveAI Clinical SDK

Measure Labs, Inc. (Dba Preemptiveai, Inc.)

Cleared 2026-02-13

Registered with
  • US (FDA)
Wrist Blood Pressure Monitor (BPM-W1VL)

Shenzhen IMDK Medical Technology Co, Ltd

Cleared 2026-02-13

Registered with
  • US (FDA)
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2026-02-13

Registered with
  • US (FDA)
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

Shenzhen Hingmed Medical Instrument Co., Ltd.

Cleared 2026-02-13

Registered with
  • US (FDA)
Argos Infinity (Rev. 1.0)

Retia Medical Systems, Inc

Cleared 2026-02-13

Registered with
  • US (FDA)
Motion InBra (YM-8801) wearable breast pump

Medela, Inc.

Cleared 2026-02-13

Registered with
  • US (FDA)
ARCHITECT FREE PSA

Abbott Laboratories

Cleared 2026-02-12

Registered with
  • US (FDA)
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application

Medtronic Navigation Inc

Cleared 2026-02-12

Registered with
  • US (FDA)
Freestyle Bioprosthesis

Medtronic, Inc

Cleared 2026-02-12

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

SZ KKS Silicone&Electronic Co., Ltd.

Cleared 2026-02-12

Registered with
  • US (FDA)
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

Guangzhou Hehong Biotech Co., Ltd.

Cleared 2026-02-12

Registered with
  • US (FDA)
Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test

Healgen Scientific, LLC

Cleared 2026-02-12

Registered with
  • US (FDA)
Well-Life Incontinence Stimulation System (WL-2405i(P))

Well-Life Healthcare, Inc.

Cleared 2026-02-12

Registered with
  • US (FDA)
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

Roche Diagnostics GmbH

Cleared 2026-02-12

Registered with
  • US (FDA)
Wrist Fracture System

Met One Technologies

Cleared 2026-02-12

Registered with
  • US (FDA)
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

Tianjin Huahong Technology Co, Ltd

Cleared 2026-02-12

Registered with
  • US (FDA)
PuraCath Firefly Needleless Connector IT (9005)

Puracath Medical, Inc.

Cleared 2026-02-12

Registered with
  • US (FDA)
IMAGE1 (TC400US); X-to-4U Adapter (TC040)

Karl Storz SE & CO.KG

Cleared 2026-02-12

Registered with
  • US (FDA)
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

Roche Diagnostics GmbH

Cleared 2026-02-12

Registered with
  • US (FDA)
Lumbar Spine Truss System Plating Solution (LSTS-PS)

4Web, Inc.

Cleared 2026-02-12

Registered with
  • US (FDA)
L12 LED Light Source with AIM

Stryker Endoscopy

Cleared 2026-02-12

Registered with
  • US (FDA)
Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)

Xenocor, Inc.

Cleared 2026-02-12

Registered with
  • US (FDA)
MINERVA ENDOMETRIAL ABLATION SYSTEM

Axora Medical, Inc.

Cleared 2026-02-12

Registered with
  • US (FDA)
SteriHub™ Disinfecting Device and Protective Cover

1World Vista Medical

Cleared 2026-02-11

Registered with
  • US (FDA)
iFuse INTRA Ti™ Implant System

Si-Bone, Inc.

Cleared 2026-02-11

Registered with
  • US (FDA)
AI4CMR v2.0

AI4MedImaging Medical Solutions SA

Cleared 2026-02-11

Registered with
  • US (FDA)
CURIS II RF Generator (REF 360100-05)

Sutter Medizintechnik GmbH

Cleared 2026-02-11

Registered with
  • US (FDA)
AXS Lift Intracranial Base Catheter

STRYKER NEUROVASCULAR

Cleared 2026-02-11

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
ArmSure Fluoroscopic Positioning System

Savfe Co. , Ltd.

Cleared 2026-02-11

Registered with
  • US (FDA)
Delivery Date AI

Ultrasound AI

Cleared 2026-02-11

Registered with
  • US (FDA)
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-02-11

Registered with
  • US (FDA)
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

UROMEDICA, INC.

Cleared 2026-02-11

Registered with
  • US (FDA)
LANDR Contact LENS Case

Fourth Axis, LLC

Cleared 2026-02-10

Registered with
  • US (FDA)
Optimum Infinite (tisilfocon A) Orthokeratology Lenses II

Contamac, Ltd.

Cleared 2026-02-10

Registered with
  • US (FDA)
SpaceOAR Vue System (SV-2101)

Boston Scientific Corp

Cleared 2026-02-10

Registered with
  • US (FDA)
XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

Biodynamik, Inc.

Cleared 2026-02-10

Registered with
  • US (FDA)
CollOvine™ Wound Powder

Ovigenex, LLC

Cleared 2026-02-10

Registered with
  • US (FDA)
GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only

Shenzhen RF Tech Co., Ltd.

Cleared 2026-02-10

Registered with
  • US (FDA)
multiFlux 130 (F00013123); multiFlux 160 (F00013124)

Fresenius Medical Care Renal Therapies Group, LLC

Cleared 2026-02-10

Registered with
  • US (FDA)
MI View&GO

Siemens Medical Solutions USA, Inc.

Cleared 2026-02-10

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Attain StarFix Lead

Medtronic, Inc

Cleared 2026-02-10

Registered with
  • US (FDA)
NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)

Medtronic Xomed

Cleared 2026-02-10

Registered with
  • US (FDA)
Vulcan Spinal System

K2M, Inc

Cleared 2026-02-10

Registered with
  • US (FDA)