FDA 510(k) clearances — page 340
clearances on record, most recent first.
Clearances — page 340
33,901–34,000 of 175,770- K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
- K150064 — Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
- K150442 — Volcano Visions PV .018 Digital IVUS Catheter
- K150768 — JuggerKnot Soft Anchors
- K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
- K151160 — Arcus Staple System
- K151248 — PIEZOSURGERY WHITE
- K151249 — PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
- K151270 — CrossTIE Intraosseous Fixation System
- K151442 — TOTAL COMPRESSION PLATING (TCP) SYSTEM
- K151521 — Phoenix Thera-Lase System
- K151538 — NuVasive PEEK Corpectomy Railed System
- K151733 — Xenco Medical Pedicle Screw System
- K151822 — ab medica irrigation/suction gravity system
- K151838 — PRO-TOE Hammertoe Fixation System
- K152015 — Pyrenees Cervical Plate System
- K152176 — Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K140310 — Peristeen Anal Irrigation System
- K141960 — Exactech® Novation® Crown Cup®
- K142982 — OPUS 5100 Diagnostic Doppler Ultrasound System
- K143631 — Benefix Interspinous Fixation System
- K150265 — Model 206 Electrometer/Dosimeter
- K150812 — Genesys Spine Apache Cervical Interbody Fusion System
- K150852 — SIC 8000
- K151167 — NuVasive PEEK Corpectomy System
- K151440 — Klassic HD Hip System
- K151666 — Leksell GammaPlan
- K151705 — Lotus Posterior Cervical/Thoracic Spinal System
- K151885 — SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System
- K151902 — REDAPT¿ Revision Femoral System
- K152170 — Exactech Optetrak Logic Enhanced Assembly
- K152220 — MH01
- K152230 — Ebony PTA .014 RX Pheripheral Dilatation Catheter
- K152250 — SpeqRT
- K152396 — S12 Digital Color Doppler Ultrasound System
- K140939 — HAMILTON-T1,HAMILTON-C1
- K142592 — CleanSmart Wound Cleanser
- K143267 — TempTraq TT-100
- K143586 — FACT Medical Imaging Sysytem
- K143661 — DirectInject
- K150082 — Panorama Patient Monitoring Network
- K150124 — Cardinal Health NPWT PRO HC
- K150352 — V Series Monitoring System (including V12 and V21 Monitors)
- K151766 — BD Single Use, Hypodermic Syringe
- K151783 — COMPACT INTUITIV Multiple-Use Pack
- K151860 — Infinity CentralStation Wide
- K151869 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K152143 — TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
- K152148 — Fortress Pedicular Fixation System
- K152208 — The Belmont Hyperthermia Pump
- K150239 — FibroScan
- K150883 — HyaloGYN Vaginal Hydrating Gel
- K150977 — CIRRUS HD-OCT
- K151171 — TRAUS SUS10
- K151473 — NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
- K151575 — Dynarex Eye Cups
- K151957 — BOX DICOM Viewer
- K143539 — Dental Implant OKTAGON Bone Level
- K150143 — Normal Saline Flush
- K150146 — Biogel PI Micro Indicator Underglove
- K150896 — Vitality Spinal Fixation System
- K151006 — EarlySense Central Display Station (CDS)
- K151459 — Integra Total Ankle Replacement System
- K152174 — Sniper Spine System
- K143424 — UTAH CVX-RIPE
- K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
- K143579 — NuVasive Sterilization Trays
- K150154 — ANAM Test System: Military Battery
- K150288 — PDO Absorbable Punctum Plug
- K150412 — Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
- K150556 — Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
- K150894 — VIA 21 Microcatheter
- K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- K151088 — DMRC Bulk Fill
- K151206 — Fingertip Pulse Oximeter
- K151319 — Eko Electronic Stethoscope System
- K151732 — Arthrex Fracture Plates
- K151768 — Menicon Saline Rinse Solution
- K152133 — IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System
- K152164 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
- K143454 — Pruitt F3-S Carotid Shunt
- K143721 — PRCT2
- K143724 — COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
- K143738 — DSS Sinusplasty Balloon Catheter
- K150040 — Implanova
- K150289 — CARDIOLINE HD+
- K150357 — Reprocessed Electrophysiology Diagnostic Catheters
- K150572 — Respire Pink Series-Herbst-EF
- K150771 — RxG Distraction System
- K150786 — Rezum System
- K151305 — SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
- K151349 — Advanced Perfusion System 1
- K151437 — ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
- K151740 — JAZZ System
- K151753 — 16 ch Tx/Rx Knee SPEEDER
- K152116 — 5.5 F Worley Advanced LVI Lateral Vein Introducer
- K142976 — UltraTENS
- K143203 — AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe
- K143512 — ActiSpec Activity Monitor
- K143701 — EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.