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
Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
Medtronic Sofamor Danek, Inc.
Xpert Xpress MVP; GeneXpert Xpress System
Cepheid
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-F
Karl Storz Endovision, Inc.
BTL-299-F
BTL Industries, Inc.
Newclip Patient-matched instrumentation non sterile PSI
Newclip Technics
Pounce Sheath
Surmodics,Inc.
Elecsys Tg II
Roche Diagnostics
Disposable Medical Mask
Jiangsu Nanfang Medical Co., Ltd.
NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-
Raumedic AG
ASEPT® Glide Peritoneal Drainage System
Pfm Medical, Inc.
SAFIRA
Medovate Limited
3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indi
3M Company
CardioPhase® hsCRP
Siemens Healthcare Diagnostics Products GmbH
United U2 femoral head, 22mm delta ceramic head
United Orthopedic Corporation
Sim&Size
Sim&Cure
SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LO
Satelec - Acteon Group
ArtUs
Telemed
3M Filtek Supreme Flowable Restorative
3M Company Espe Dental Products
OnPoint Augmented Reality Spine System
Onpoint Surgical, Inc.
Overjet Multi-Image Caries and Charting Assist
Overjet, Inc.
Nurochek-II System
Headsafe Mfg Pty, Ltd.
TC Gloves
Thanh Cong Pharmaceutical and Trading Company Limited
Miris Human Milk Analyzer (HMA)
Miris AB
ArteVu
Cardio Ring Technologies, Inc. Taiwan Branch
Treace Medical Concepts (TMC) Hammertoe Fixation System
Treace Medical Concepts, Inc.
ulrichINJECT CT Motion (XD 8000)
Ulrich GmbH & Co. KG
NextDent Ortho Flex
Vertex-Dental B.V.
LUOFUCON® Antimicrobial Wound Gel
Huizhou Foryou Medical Co., Ltd.
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Prevention
SOFIA EX Intracranial Support Catheter
MicroVention, Inc.
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