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.
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