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
TRUST
Rgorithm Korea
Pectus Blu Support Bar System
Biomet Micofixation
RODIN Palette Naturalizing Kit
Belport Company, Inc., Gingi-Pak
OSTEOMNI SPINAL CAGES SYSTEM
Osteomni, Inc.
Vantage PSI System
3D Systems, Inc.
Colli-PeeDx Urine Collection Kit
DNA Genotek, Inc.
SmartGuard Anti-Snoring Device
Smartguard Rx, Inc.
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Guilin Hbm Health Protections, Inc.
Ligence Heart
Ligence Uab
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (H
Smith & Nephew, Inc.
KARL STORZ Endoscopic Accessories for Urology
Karl Storz SE & CO. KG
Blue Eye (TS-905)
The Standard Co., Ltd.
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Hospital Equipment Manufacturing Company
CavaClear Laser Sheath
Spectranetics, Inc.
AUTION EYE AI-4510 Urine Particle Analysis System
Arkray, Inc.
TitanPico Laser Workstation (PICO-450)
Rhein Laser Technologies Co., Ltd.
PowerWire® 14 Radiofrequency Guidewire Kit
Baylis Medical Technologies, Inc.
VERIFY STEAM Integrating Indicator
STERIS Corporation
TDM Plate and Screw System
Tdm Co., Ltd.
Nitrile Powder Free Examination Gloves Biodegradable (Green)
Comfort Rubber Gloves Industries Sdn. Bhd.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
See-Mode Technologies Pte, Ltd.
UV5000W Handle
Uroviu Corporation
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Boston Scientific Corporation
Surgical Face Mask
Zhejiang Hongyu Medicali Commodity Co., Ltd.
Pitkar Spinal Pedicle Screw System
S.H.Pitkar Orthotools Pvt. , Ltd.
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
Shenzhen Lifotronic Technology Co., Ltd.
TriALTIS Spine System
Medos International SARL
Telemetry Monitor 5500 Release 4.0 (867232)
Philips Medizin Systeme Böblingen GmbH
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
MicroVention, Inc.
Clever One
Ewoosoft Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert