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
1NEED Pro
Campomats S.R.L.
cobas liat CT/NG/MG nucleic acid test
Roche Molecular Systems, Inc.
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
Beckman Coulter, Inc.
HD Mediastinoscope
Karl Storz Endoscopy America, Inc.
Healgen® Accurate Oral Fluid Drug Test
Healgen Scientific,, LLC
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
Stryker Corporation (Tornier, Inc.)
Dream Sock
Owlet Babycare, Inc.
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
Tigon Medical
Chiavaye Personal Moisturizer
Unipack, LLC
Universal Endometrial Applicator Set (GM11009840)
Varian Medical Systems, Inc.
Interson USB Ultrasound System
Interson Corporation
i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Quantib ND
Quantib B.V.
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
Spectrum Medical S.R.L.
Klassic Knee Revision System
Total Joint Othopedics, Inc.
Universal Tendon Spacer
Askorn Medical
Onclarity Self-Collection Kit
Becton, Dickinson and Company
Synthecure Synthetic Calcium Sulfate
Austin Medical Ventures, Inc.
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Hangzhou Laihe Biotech Co., Ltd.
Unscented menstrual three-piece applicator tampon
Unibeauty (Hubei) Technology Co., Ltd.
SOMNUM (SOMNUM)
Honeynaps Co., Ltd.
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Karl Storz SE & CO. KG
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Mu
Hangzhou AllTest Biotech Co., Ltd.
Acumed Acutrak 3 Headless Compression Screw System
Acumed, LLC
RTapp
Segana, Inc.
Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Reso
Boston Scientific Corporation
SilentCloud
Aureliym GmbH
OrangeCAD Med Abutments
Orangecad Med GmbH
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
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