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

Eminent Spine SI Screw System

Eminent Spine, LLC

Genie MAX Large Bore Introducer Sheath

Cultiv8 1, LLC

Hemastyl(™) Wound Dressing

Rapid Nexus Nanotech Wound Solutions, Inc.

CloudCath Peritoneal Dialysis Drain Set Monitoring System

Cloudcath

RI.HIP MODELER

Blue Belt Technologies, Inc.

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20

Shenzhen Smallsignal Technology Co., Ltd.

PlazMagik

Agnes Medical Co., Ltd.

Cassette Autoclave (ACA5)

Guangzhou Ajax Medical Equipment Co., Ltd.

Transducer Probe Cover

Hony Medical Co., Ltd.

Zamenix™ P

Roen Surgical, Inc.

Compact Wearable Pump

Lansinoh Laboratories

ClearHemograsper

Finemedix Co., Ltd.

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Changsha Honchon Technology Co., Ltd.

CentriMag Pre-connected Pack

Abbott

MediLab

Sigma Scientific Services, LLC

G7, Dental Operative Unit and Accessories

Shinhung Company, Ltd.

Galen™ Second Read™

Ibex Medical Analytics , Ltd.

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

Edwards Lifesciences, LLC

Firstar Dental Electric Motor

FDC Technology Industry Co.

EMBOGUARD Balloon Guide Catheter

Neuravi Limited

Glass Ceramic

Shenzhen Xiangtong Co., Ltd.

Firefighter™ Pro PTCA Balloon Catheter

Shanghai MicroPort Medical (Group) Co., Ltd.

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System

Synthes GmbH

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

Zhejiang Gongdong Medical Technology Co., Ltd.

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

Telefield Medical Imaging (Shenzhen) Limited

Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL

Thermo Fisher Scientific

Fusion Craniofacial Implant; Fusion Skull Implant

Kelyniam Global, Inc.

Veritas Reverse Total Shoulder System

Restor3D

Safety lancet (XL)

Tianjin Huahong Technology Co., Ltd.

BioPoly Radial Head Implant

BioPoly, LLC

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