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

Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Bl

Shenzhen AOJ Medical Technology Co., Ltd.

Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Re

Ge Medical Systems, LLC

KARL STORZ Trocars with Valve Seals

Karl Storz SE & CO. KG

Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)

Anhui Jbh Medical Apparatus Co., Ltd.

ReFlow System Mini

Anuncia Medical, Inc.

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 36

Cardiovascualr Systems, Inc.

TDM Large Bone Plate and Screw System

Tdm Co., Ltd.

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

Thera B Medical Products

VivaChek Link Plus Blood Glucose Monitoring System

Vivachek Biotech (Hangzhou) Co., Ltd.

Universal Seal (5-12 mm)

Intuitive Surgical, Inc.

AccuCTP Pro

ArteryFlow Technology Co., Ltd.

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

Qingdao Hightop Biotech Co., Ltd.

Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

Genadyne Biotechnologies, Inc.

cmAngio® (V1.6)

Curemetrix, Inc.

Chemotherapy Gloves

3A Glove Sdn. Bhd.

IceCap product line

Bioserenity Medical Devices Group

OrthoFit

Spident Co., Ltd.

MSS - Monobloc stem

Medacta International S.A.

OpenRad Cloud

Openrad Services Uk, Ltd.

Advanced Algorithms for Treatment Management Applications (AATMA)

Elekta Solutions AB

CollOvine™ Wound Powder

Ovigenex, LLC

Vena MicroAngioscope™ System

Vena Medical Holdings Corp

Fine TTO™

Bodycad Laboratories, Inc.

da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System

Intuitive Surgical, Inc.

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Inte

Qura S.R.L

Invisalign Palatal Expander System

Align Technology, Inc.

Kenota 1 Total IgE; Kenota 1 (instrument)

Kenota, Inc.

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

Genmark Diagnostics, Incorporated

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Shenzhen Sophway Technology Co., Ltd.

Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

Shenzhen Fansizhe Science and Technology Co., Ltd.

← PrevPage 116 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert