FDA 510(k) clearances — page 293
clearances on record, most recent first.
Clearances — page 293
29,201–29,300 of 175,699- K162820 — AC3 Series IABP System
- K162873 — MEP Monitor
- K163096 — GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
- K163350 — Multibase Abutments EV and ATLANTIS Suprastructures
- K163649 — SureSigns VS3; SureSigns VS4
- K170098 — ICONIX TT All Suture Anchor
- K170243 — LOSPA IS TLIF & DLIF Cages
- K170284 — Great Basin Bordetella Direct Test
- K170449 — Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
- K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
- K170628 — BioMonitor 2-AF, BioMonitor 2-S
- K170783 — CX50N(CX50YQS)
- K162471 — Hach CM130 Chlorine Monitoring System
- K162995 — Ibis® Pedicle Screw System
- K170009 — Esophageal Cooling Device
- K170077 — LUOFUCON Silicone Ag Foam Dressing with Border
- K170271 — NuVasive(r) Monolith Corpectomy System
- K170310 — Alians Clavicle range
- K170327 — Parcus SLiK Anchors
- K170635 — Chameleon PTA Balloon Catheter
- K170743 — AngioDynamics Total Abscession Biliary Drainage Catheter
- K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
- K161929 — Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
- K162124 — Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
- K162693 — VertebraLINK Fusion Platform
- K162999 — V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
- K163052 — Brevera Biopsy System with Corlumina Imaging Technology
- K163529 — ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
- K163700 — Bodycad Unicompartmental Knee System
- K170161 — New Deantronics E Green Electrosurgical Monopolar Pencils
- K170654 — USS System
- K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
- K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
- K162405 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)
- K162789 — Foresight Intracardiac Echocardiology (ICE) System
- K163565 — MR8 Drill System
- K170476 — Nio Color 5.8MP (MDNC-6121)
- K170493 — HS50 / HS60 Diagnostic Ultrasound System
- DEN160028 — ipsogen JAK2 RGQ PCR Kit
- K161667 — Sapphire Infusion Pump
- K161731 — Cleveland Multiport Ventricular Catheter Set
- K161812 — Freedom Syringe
- K163248 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K162784 — Silk'n HST
- K160581 — K3PRO Konus Additional Abutments and Implants
- K161680 — MEDICON Spinal Spreading Systems
- K161835 — iovera system
- K162023 — CardioDay V2.5
- K162028 — PREMIUM - SHELTA Prosthetic Components
- K162235 — LUVENA VAGINAL MOISTURIZER & LUBRICANT
- K162342 — Stellaris Elite Vision Enhancement System
- K162503 — Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
- K162556 — LIGHTFUSION LED SYSTEM
- K162615 — Mould Applicator Set
- K162701 — VERIFY Assert Self-Contained Biological Indicator
- K162850 — GuideMia Ortho+
- K162967 — nuance UNIVERSAL
- K162979 — Veloxion System
- K163249 — GoSpiro
- K163267 — NITRILE EXAMINATION GLOVE
- K163290 — INFINITT ULite
- K163297 — Scan&GO
- K163425 — NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
- K163491 — NuVasive CoRoent Small Interbody System
- K163587 — VERIFY Incubator for Assert Self Contained Biological Indicators
- K170204 — FFR Link, FFR Signal Processing Module
- K170329 — Basic, Dominant Flex
- K170335 — Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
- K170701 — GEN_2 and GEN_3 Mechanical Wheelchairs
- K161428 — PerfectSmooth
- K162037 — Eclipse with VEMP
- K162217 — LOYON
- K163103 — Tranberg CLS Diffusor Laser Fiber
- K163182 — Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
- K163314 — Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
- K163558 — Synapsys Ulmer Video Nystagmograph
- K170277 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
- K161141 — ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
- K161979 — ENFit enteral syringe
- K163017 — Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
- K163099 — My Dose Coach
- K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family
- K163300 — ThermoShield HME Filter
- K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
- K170530 — Butrex Lumbar Buttress Plating System
- K170636 — Fathom-16 Steerable Guidewires
- K152534 — Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
- K162740 — MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
- K162758 — VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
- K163157 — SmartGrid
- K163296 — SOMATOM go.Up, SOMATOM go.Now
- K163320 — LAP-Pump PP110
- K163343 — Icare HOME tonometer
- K163401 — Nix Ultra Lice Treatment Kit
- K163405 — 360KS Implant Positioning System
- K163608 — HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
- K163637 — BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
- K160139 — Luggie Chair
- K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
- K161691 — Direct LDL Cholesterol (LDL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.