FDA 510(k) clearances — page 348
clearances on record, most recent first.
Clearances — page 348
34,701–34,800 of 176,542- 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
- K150274 — GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
- K150658 — Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
- K150823 — EDLENi Intra-Oral Sensor
- K151008 — LINK® MEGASYSTEM-C®
- K152070 — BioZorb LP Marker
- K152071 — NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
- K152076 — PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
- K152081 — Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
- K152165 — S9 Portable Digital Color Doppler Ultrasound System
- K142351 — 25-Hydroxy Vitamin Ds EIA
- K142760 — Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
- K143648 — BD MAX Enteric Parasite Panel, BD MAX Instrument
- K150971 — Zekang Self-adhesive Electrode
- K151345 — BioGuard Air/Water Valve, BioGuard Suction Valve
- K151797 — Nuocande Plastic Manual Wheelchair Model NKD L07
- K152097 — Retraction Aspirator
- K150205 — LED Curing Light
- K150685 — Skynector CPAP Mask
- K151343 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
- K143348 — BC-3600 Auto Hematology Analyzer
- K143444 — SynePure Wound Cleanser
- K143487 — Lifelines iEEG
- K143529 — UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
- K143692 — GranOSTM - beta tricalcium phosphate synthetic bone granules
- K150673 — SYNFIX Evolution Secured Spacer System
- K150704 — PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
- K151087 — CS 8100SC, CS8100SC Access
- K151213 — UCP Drug Test Mini Cups
Data sourced from openFDA. This site is unofficial and independent of the FDA.