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
Remanufactured EndoWrist Tenaculum Forceps (420207)
Rebotix
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w
Thermo Fisher Scientific
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
Thermasolutions, LLC
TruAbutment DS; TruBase
Truabutment, Inc.
LISA Laser Surgical Fibers
Omni-Guide Holdings, Inc.
Liberty SI Lateral Implant System
Spinal Simplicity, LLC
FlexitSystem Knee osteotomy system
Neosteo
UltraFlo-R Push Button Blood Collection Set
Innovative Medical Technologies, Inc.
BioGend Interbody Fusion System 001 Cage
Biogend Therapeutics Co., Ltd.
InBody Blood pressure monitor, Model BPBIO480KV
Inbody Co., Ltd.
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drug
Sentienx Sdn Bhd
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
Asahi Intecc Co., Ltd.
SCORPION Portal Vein Access Set
Argon Medical Devices
DEKA TORO
El.En S.P.A.
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
QIAGEN GmbH
Acumed Wrist Plating System
Acumed, LLC
IPL Hair Removal Device (BE965A, BE965B, BE965C)
Shenzhen Yang WO Electronic Co., Ltd.
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-
bioMerieux, Inc.
Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
Davol, Inc.
TROJAN Fire & Ice lubricated male natural rubber latex condom
Church & Dwight Co., Inc.
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
Medtronic Sofamor Danek USA, Inc.
neoLaser Laser Surgery Fibers
G.N.S Neolaser , Ltd.
Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear P
Teleflex Incorporated
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
BioButton System
Biolntellisense, Inc.
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
Stryker
EnSite X EP System
ABBOTT MEDICAL
Wearable Breast Pump (Model S1DW)
Shenzhen TPH Technology Co., Ltd.
RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTI
Xenix Medical
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert