FDA 510(k) clearances — page 88
clearances on record, most recent first.
Clearances — page 88
8,701–8,800 of 176,479- K231107 — Bronchoscope System
- K231522 — EMPHASYS Dual Mobility System
- K231659 — MS55 Plus Digital Color Doppler Ultrasound System (MS55) +5 more
- K232245 — VedDilator ^TM (3-Stage Balloon Dilation Catheter)
- K232915 — EpiMonitor
- K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
- K233656 — Contour Shoulder
- K234028 — COPAL® exchange G hip spacer; COPAL® G+V
- K234036 — SONIK MONARK 100
- K240130 — Medical Monitor (21HQ613D)
- K240157 — InVision 1.5 Surgical Theatre
- K231514 — Azure
- K233678 — Radiography 7000 M
- K240427 — airVata
- K231134 — VerteLoc Spinal System
- K231855 — QOCA® image Smart RT Contouring System
- K231990 — Apex Locator
- K232082 — EXPD 4343S
- K233661 — Transorb Self-Gripping Resorbable Mesh
- K233740 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile
- K233788 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K233954 — Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
- K233959 — EPi-Ease Epicardial Access Device (EAS)
- K234048 — M.U.S.T. Pedicle Screw System - Extension
- K234123 — Easi-Vue® embolic microspheres System
- K231468 — SCOUT MD Surgical Guidance System
- K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope
- K232674 — PainFreeze II
- K233040 — EMS/TENS Massager Device
- K233092 — Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
- K233134 — I.T.S. INS Proximal Femur Nail
- K233217 — Mimics Cardiac Planner
- K233260 — Univers Revers CA Head and Adapter
- K233401 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
- K233533 — NerveTape
- K233635 — SPY Cystoscope/Hysteroscope
- K233667 — Facial Toning device (UIC-189); Facial Toning device (UIC-589)
- K231355 — Aurora
- K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor
- K232072 — AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
- K232473 — Infrared Thermometer: Model YJ600
- K233464 — WSA Self-Fitting Hearing Aid Gen 2
- K233631 — ZapStim Controller Application (Z1023)
- K233638 — VERZA High Speed Drills
- K234034 — VenaCore Thrombectomy Catheter (46-101)
- K234037 — CATS-L Tonometer Prism
- K240066 — Fine Osteotomy
- K240072 — Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
- K240084 — V-STRUT® Vertebral Implant
- K240098 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K230839 — Concentriq Dx
- K231536 — eQUANT System
- K231575 — Vecttor VT-300
- K231662 — Aid-U
- K231913 — T-FIT
- K232644 — neuro42 MRI System
- K232854 — Leksell GammaPlan (LGP)
- K233024 — Alma Harmony
- K233080 — HealthFLD
- K233184 — T2Bacteria® Panel
- K233350 — SINC Support Catheter
- K233476 — Z1 Hip System
- K233480 — Access SHBG
- K233504 — Lexa MINI (RIS-303, RIS-305)
- K233914 — XVbeam2000
- K240069 — Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
- K240086 — Ion 3D
- K231956 — F&P Optiflow+ Duet Nasal Cannula
- K232171 — Purema® H Hemoconcentrator (EtO Sterilized)
- K232764 — Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K240064 — Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
- K240075 — FUJIFILM Endoscope Model EB-710XT
- DEN230041 — Sleep Apnea Feature
- K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap
- K233115 — Hawkeye Control Unit with Eyas Endoscope
- K233221 — Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
- K233416 — Cryojet Plus (SHE-ACP001-1)
- K233593 — MAGEC Spinal Bracing and Distraction System
- K233897 — 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
- K233960 — INNOVERSE Spinal System
- K232363 — Viz HDS, Viz Volume Plus, Viz ICH+
- K232379 — PREVENT Kit
- K232694 — Central Monitoring System (MFM-CMS)
- K233174 — FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
- K233600 — Smart Fit Knee 3.0T
- K233895 — EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA) +2 more
- K234013 — Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
- K234075 — Flow-Nail
- K240099 — Ziehm Vision RFD
- K232210 — X-trodes System M
- K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- K230548 — Myoaligner Appliance
- K231325 — Corplex P / Theracor P / Allacor P
- K231373 — BD Vacutainer® K2 EDTA Blood Collection Tubes
- K231534 — 5008X Hemodialysis System
- K231625 — VitalDetect
- K233143 — PiXel8-Reveal
- K233472 — CVAC Aspiration System + CVAC Image Processor
- K233531 — OIC FLEX-FIX System
- K233756 — Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
Data sourced from openFDA. This site is unofficial and independent of the FDA.