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
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
Thompson Surgical Instruments, Inc.
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
MacroLux Medical Technology Co., Ltd.
ClariCT.AI
Claripi, Inc.
MyKnee R Pin Positioners
Medacta International S.A.
ApolloHipX (THR.SS.0001)
Corin U.S.A. Limited
SofWave System
Sofwave Medical, Ltd.
Dental Air Polishing Handpiece
Guilin Woodpecker Medical Instrument Co., Ltd.
REUNION Sacroiliac Joint Fusion System
Astura Medical
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Disposable Vinyl Examination Gloves
Anqing Pukang Medical Technology Co., Ltd.
SCOPE BUDDY PLUS Endoscope Flushing Aid
Medivators, Inc.
Biomet Microfixation OmniMax MMF System
Biomet Microfixation
Sterile Syringes for Single Use
Shanghai Kindly Enterprise Development Group Co., Ltd.
ABL90 FLEX PLUS System, safeCLINITUBES
Radiometer Medicals Aps
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
Macromedics BV
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
Terumo Europe N.V.
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen®
Healgen Scientific,, LLC
PathBuilder Transseptal Needle
Shanghai Microport EP Medtech Co., Ltd.
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
Olympus Medical Systems Corporation
OSSIOfiber® Suture Anchor
OSSIO , Ltd.
Action Trackchair Hawk
Action Manufacturing, Inc.
Alinity m HCV
Abbott Molecular, Inc.
MiRus MoRe Lumbar Plating System
MiRus, LLC
OmniTrans Transport System
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Needle Free Connector
Medcaptain Life Science Co., Ltd.
PathKeeper System
Pathkeeper Surgical , Ltd.
preCARDIA Occlusion System
Abiomed, Inc.
ComASP Cefiderocol 0.008-128
Liofilchem s.r.l.
TRAUMAGEL® 2.0 Hemostatic Gel
Cresilon, Inc.
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
Atraverse Medical
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