RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

SurGenTec, LLC

Klassic Infection Spacer System

Total Joint Orthopedics, Inc.

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V

Remex Medical Corporation

CoreLevee

Lutronic Corporation

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)

Dolanvy (Suzhou) Medical Technology Co., Ltd.

aprevo® anterior lumbar interbody fusion device with interfixation

Carlsmed, Inc.

LAIA XR

Augmented Reality Software S.L.

CEPHX3D

Orca Dental AI , Ltd.

DESS Dental Smart Solutions

Terrats Medical SL

THERMOCLICK

T&R BIOFAB CO., Ltd.

Ultiri Measurement System

ABBOTT MEDICAL

EasyOne Sky Spirometer

Ndd Medizintechnik AG

Heel Stick Safety Lancet (HHZ-II, HHZ-III)

Tianjin Huahong Technology Co., Ltd.

Extremity Staple

Restor3D

Access TPO Antibody

Beckman Coulter, Inc.

INNOVISION-EXII

Dk Medical System

CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister

Argon Medical Devices, Inc.

Stable-L Standalone Lumbar Interbody System

Nexus Spine, LLC

Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI

Medline Industries, Inc.

Sil-Flow

Dsi Dental Solutions, Ltd.

brAIn™ Shoulder Positioning

Avatar Medical

TENSOR® Suture Button System

Globus Medical, Inc.

Eonis SCID-SMA kit

Perkinelmer, Inc.

FOX 810, FOX 980

A.R.C Laser GmbH

Sperm Freezing Medium

Gimbo Medical Technology Shenzhen Co., Ltd.

Albumin BCP2

Abbott Ireland Diagnostics Division

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

Philips Medical Systems Nederland B.V.

Clevaligner Software (V1.0.0)

Clevaligner, Ltd.

EnteraLoc Flow

Vonco Products

Nobel Biocare S Series Implants

Nobel Biocare AB

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