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
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cycl
Central Medicare Sdn Bhd
Fine Osteotomy
Bodycad Laboratories, Inc.
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Jiujiang Taixin Technology Co., Ltd.
AION TempShield
Aion Biosystems, Inc.
Partial Flex
Clemde SA DE CV
ICS Dizcovery (1091)
Natus Medical Denmark Aps
swiftPro System
Emblation , Ltd.
LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
Lina Medical Aps
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Quanta Dialysis Technologies, Ltd.
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
Longly Biotechnology (Wuhan) Co., Ltd.
Renova RP Centesis Pump
Gi Supply, Inc.
ArtiSential Laparoscopic Instruments-Electrodes
Livsmed, Inc.
Socko Vimax Spinal Fixation System
Socko Medical Co., Ltd.
VITROS AFP
Ortho Clinical Diagnostics
Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC
OTOPLAN
Cascination AG
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP
Depuy Ireland UC
Materialise TKA Guide System
Materialise NV
Somfit D
Compumedics Limited
UltraPrint-Dental Denture UV
Guangzhou Heygears IMC., Inc.
DESS Dental Smart Solutions
Terrats Medical SL
Terragene® Bionova® BT20 Biological Indicator
Terragene
K-Bond Universal
Spident Co., Ltd.
Soniquence Reusable Neutral Plate
Soniquence, LLC
Insignia Hip Stem
Stryker Orthopaedics
ANT-X System
Ndr Medical Technology Pte. , Ltd.
Alveoair Digital Spirometer
Roundworks Technologies Private Limited
Distal Elbow Plating System
Skeletal Dynamics, Inc.
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
Gimbo Medical Technology Shenzhen Co., Ltd.
Procedure Mask
Little Rapids Corporation
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