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

Swedge™ Pedicle Screw Fixation System Bezier Rod

Spinal Resources, Inc.

Pounce XL Thrombectomy System (PTS-1011-7F135)

Surmodics,Inc.

KARL STORZ Trocars with Valve Seals

Karl Storz SE & CO. KG

Air Compression Leg Massager (K-705)

Jiale Health Technology Shenzhen Co., Ltd.

Mini-ClotTriever Thrombectomy System

Inari Medical

Apollo TMS Therapy System

Mag & More GmbH

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

Arftx Medical, LLC

Zimmer Persona Personalized Knee System

Zimmer, Inc.

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Centers for Disease Control and Prevention

XBody Go USA, XBody Pro USA

Xbody Hungary Kft.

HAVAb IgG II

Abbott Laboratories

MIM – Monte Carlo Dosimetry

Mim Software, Inc.

Guiding Catheter

CenterPoint Systems, LLC

OrthoNext Platform System

Orthofix Srl

Combo Electrotherapy Device

Shenzhen Roundwhale Technology Co. , Ltd.

ArcSP Suprapubic Sling System

Urocure, LLC

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer

Carl Zeiss Meditec, AG

Triathlon® Total Knee System - Triathlon® Gold Femoral Components

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

LINK Endo-Model EVO Knee System

Waldemar Link GmbH & Co. KG

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

Drägerwerk AG Co. Kgaa

Finger Clip Pulse Oximeter

Guangdong Genial Technology Co., Ltd.

FlexCath Cross Transseptal Solution

Acutus Medical, Inc.

iFuse-TORQ® Implant System

SI-BONE, Inc.

Electro Lube NXT

Steris

InThrill™ Thrombectomy System

Inari Medical, Inc.

Activmotion S DTO

Newclip Technics

Universal Tendon Spacer

Askorn Medical

Stable-L Standalone Lumbar Interbody System

Nexus Spine, LLC

BriefCase

Aidoc Medical , Ltd.

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, B

Shenzhen Best Electronics Co., Ltd.

← PrevPage 2 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert