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
Versalock Rib and Sternum Plates System
GM Dos Reis Industria e Comercio Ltda.
Cove Putty, OsteoCove Putty
SeaSpine Orthopedics Corporation
Power Wheelchair (JJW-6001)
ZheJiang J&J Mobility Co., Ltd.
Fluido® AirGuard System
The Surgical Company International BV (As Tsc Life)
Oxus Sieve Beds
Oxus, Inc.
SonoStik Guide Wire Introducer
Sonostik, LLC
Contour ProtégéAI+
Mim Software, Inc.
Microwave Ablation Device
Nanjing Dewen Medical Technology Co., Ltd.
Boehringer Laboratories Liver Retractor
Boehringer Laboratories, LLC
ORAcollect®Dx
DNA Genotek, Inc.
Sugita AVM Microclip Applier
Mizuho America, Inc.
PrecivityAD2 Test
C2N Diagnostics, LLC
EchoSolv AS
Echo IQ, Ltd.
IPL Hair Removal Device
Ulike Co., Ltd.
Vigilant Software Suite Vigilant Master Med
Fresenius Kabi AG
Merge Universal Viewer (MUV)
Merge Healthcare Incorporated
LOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics
UltraSight AI Guidance
Ultrasight, Inc.
OptiComp
Pac-Dent, Inc.
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, A
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
MAVERICK External Fixation System
Smith & Nephew, Inc.
Laser hair growth helmet
Kam Yuen Plastic Products , Ltd.
OsteoFlo HydroFiber
SurGenTec, LLC
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
Guangzhou Decheng Biotechnology Co., Ltd.
LF900
Daesung Maref Co., Ltd.
Green X 21 (PHT-90CHO)
VATECH Co., Ltd.
Medicell Mycosis Laser (MCML24004)
Medicell Healthcare Co.,LTD
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
Arthrex, Inc.
canturio® se (Canturio Smart Extension)
Canary Medical USA, LLC
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
Medtronic, Ireland
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert