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
MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert
Medisono
HALO AP Dx
Indica Labs, Inc.
Caduceus S
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
OSSTM Orthopedic Salvage System
Biomet, Inc.
CS-Pro MED
Curative Sound Therapeutics
MedicloseTM System
Health Value Creation B.V., Trading AS Corporis Medical
NeVasc Aspiration System
Vesalio, Inc.
Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Eagle S/Saevo Slim/D700 Slim
Alliage S/A Industrias Medica Odontológico.
microINR System
Iline Microsystems, S.L.
Axiostat Gauze
Advamedica, Inc.
NuVasive Reline Cervical System
Nu Vasive, Incorporated
PiezoImplant System
Rex Implants, Inc.
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
Shenzhen AOJ Medical Technology Co., Ltd.
Light Therapy Decollete Mask (1019135)
Merchsource, LLC
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
Cosmo Artificial Intelligence - Ai, Ltd.
Trigon HA Wedge Fixation System
Nvision Biomedical Technologies, Inc.
Celsi Warmer
Hadleigh Health Technologies
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
Sol-Millennium Medical, Inc.
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
Imperative Care, Inc.
Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
Xaga Surgical
Extension Feeding Set with ENFit Connectors
SKY Medical, a.s.
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue El
Boston Scientific Corporation
LMNT O2
Xplr , Ltd.
Tontarra Punches and Rongeurs
Tontarra Medizintechnik GmbH
SMARTDent
Ray Co., Ltd.
Electric wheelchair (C001)
Zhejiang Hfizer Medical Equipment Co., Ltd.
CARESCAPE B650, E-musb
GE Healthcare Finland Oy
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Rubberex Alliance Products Sdn Bhd
Pixie Skin Tag
Oystershell NV
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert