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

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color

Maxter Healthcare, Inc.

Identity Shoulder System

Zimmer, Inc.

KODEX – EPD™ System 1.5.0

Philips Medical Systems Nederland, B.V. (Pmsn)

PlumeSafe X5 Smoke Management System

Conmed Corporation

iStent infinite Trabecular Micro-Bypass System, Model iS3

Glaukos Corporation

b-ONE® Bipolar Head

B-One Ortho, Corp.

Mpact 3D Metal Implants Extension – DMLS Technology

Medacta International S.A.

KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simul

Kimberly-Clark Corporation

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

Masimo Corporation

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

Salter Labs

Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical

Hubei Xinxin Non-Woven Co., Ltd.

SwissMembrane X; SwissMembrane X Socket

Geistlich Pharma AG

IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL

Bestway Plastic and Metal Products , Ltd.

Revi System

Bluewind Medical , Ltd.

Aeka Imaging

Good Methods Global, Inc.

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

Life Spine, Inc.

Qlicksmart BladeFlask UNIVERSAL

Qlicksmart Pty , Ltd.

Micro Ace™ Advanced Micro Access System

Merit Medical Systems, Inc.

TORPEDO Implant System®

Deltacor GmbH

Aulisa Temperature Module (TM0002)

Taiwan Aulisa Medical Devices Technologies, Inc.

Electronic Apex Locator (Alpha Apex I)

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

CORE1 Implant System

Cybermed, Inc.

AI-Rad Companion Brain MR

Siemens Healthcare GmbH

UniSpace® TPLIF Cage

Cg Medtech Co., Ltd.

Arthrex SS VAL and VAL KreuLock™ Compression Screw System

Arthrex, Inc.

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Hyperfine, Inc.

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black

Aamedix Glove Sdn Bhd

ThinkQA 3

Dosisoft SA

RODIN Titan 3D Resin

Belport Company, Inc., Gingi-Pak

ReNew Disposable Scissor Tips

Microline Surgical, Inc.

← PrevPage 92 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert