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

GEM ZIPCLIP

Synovis Micro Companies Alliance A Subsidiary of Baxter Int

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger

Pall Corporation

AngioVac Cannula

AngioDynamics, Inc.

MOSES Raydar™

Boston Scientific Corporation

SafetiHeel, MediHeel, Novaplus

Nsp Tech Pte, Ltd.

BioFire COVID-19 Test 2

Biofire Defense, LLC

Safecare Urinary Tract Infection Test

Safecare Biotech (Hangzhou) Co., Ltd.

Well-Root PT

Vericom Co., Ltd.

EMPOWR Revision Knee

Encore Medical L.P.

Wesper Lab

Wesper, Inc.

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

Arftx Medical, LLC

Franz Zirconia Dental Crown

Franz Biotech, Inc.

EzDent-i / E2 / Prora View/ Smart M Viewer

Ewoosoft Co., Ltd.

JO CUMPLAY Personal Lubricant

CC Wellness, LLC

Apapro Desensitizer

Sangi Co., Ltd.

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)

Cresilon, Inc.

DRX9000C-SL Cervical Spinal Decompression System

Excite Medical of Tampa Bay, LLC

NIKKICART

Renal Care Dialysis Solutions, S.A. DE C.V.

F65 Laser System

Lumenis Be, Ltd.

AlloMap Heart Molecular Expression Testing

Caredx, Inc.

Polyver Silver Alginate Dressing (Prescription and OTC)

Roosin Medical Co., Ltd.

syngo.CT Dual Energy

Siemens Medical Solutions USA, Inc.

Anterior Spine Truss System-Stand Alone (ASTS-SA)

4Web Medical, Inc.

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

Ortho Clinical Diagnostics

HP PTA Balloon Dilatation Catheter

Kossel Medtech (Suzhou) Co., Ltd.

Prolystica Pass Thru Disinfectant Wipes

Steris

EM-07 Cordless Endo Motor

Forum Engineering Technologies (96) , Ltd.

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

CANON Fundus Camera CR-10 (CR-10)

Canon, Inc.

VALORY

Agfa N.V.

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