FDA 510(k) clearances — page 78
clearances on record, most recent first.
Clearances — page 78
7,701–7,800 of 175,620- K240619 — e-SDF
- K231210 — DGA Abutment
- K231260 — HTx Disposable Hysteroscope System
- K233526 — Medline Open-back Level 3 Protective Gown
- K233859 — BASIS FLOW II
- K234070 — Stelo Glucose Biosensor System
- K240090 — Argo Knotless GENESYS Anchor
- K240404 — NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
- K240459 — Cerament Bone Void Filler
- K240597 — TERA HARZ CLEAR
- K230047 — Medical Diode Laser Systems
- K231288 — Vyvo
- K233738 — Overjet Caries Assist-Pediatric
- K233877 — XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)
- K240453 — ReBOSSIS
- K231365 — Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
- K231648 — Muscle Stimulator
- K231690 — iCAS-LV
- K231778 — Nihon Kohden NKV-550 Series Ventilator System
- K231915 — Zfx Abutments
- K232040 — Gynatrof
- K232316 — DEKA Infusion System, DEKA Administration Set
- K232328 — Insignis Syringe Infusion System
- K232385 — OxiplexTS200
- K232791 — Access Intact PTH
- K232828 — IMAGEnet6 Ophthalmic Data System
- K233030 — BoneMRI
- K233095 — S21 OTC Transcutaneous Electrical Nerve Stimulator
- K233410 — LIAISON PLEX Respiratory Flex Assay
- K233862 — NUNA LUX (NUNL528)
- K240023 — Probe Covers (YF-001, YF-002)
- K240083 — GORE® PROPATEN® Vascular Graft
- K240277 — MiroDry Wound Matrix
- K230837 — PlazMagik
- K231683 — inHEART Models
- K232765 — MAGNETOM Cima.X Fit
- K232842 — Balloon Inflation System
- K232971 — APRO 55 Catheter and Alembic Aspiration Tubing
- K233360 — Curiteva Thoracolumbar Plate System
- K240051 — Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
- K240244 — NPseal (Small, Medium, Large)
- K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- K240268 — Accu-Joint Hemi Implant
- DEN230024 — Technozym ADAMTS13 Activity
- K231845 — Dental unit Model: Mare
- K232562 — PowerWire Radiofrequency Guidewire Kit
- K232613 — CT Cardiomegaly
- K232885 — Dawn Diode Laser System
- K233488 — Intra.Ox 2.0 Handheld Tissue Oximeter
- K233830 — OsteoCool 2.0 RF Ablation System
- K222400 — Coresculpt & Magsculpt
- K232522 — ARK Levetiracetam II Assay
- K232607 — 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
- K233435 — Peace N Quiet (0.7.0)
- K233623 — Praxiject SP 0.9% NaCl
- K233879 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)
- K233972 — Camber Sacroiliac (SI) Fixation System
- K234014 — Obsidian® NOW
- K230693 — BIS Advance Monitoring System
- K230782 — TENS device-HeadaTerm 2 (Model: YF-HT2)
- K231822 — GOLFF Sterile Anti-Fog Solution
- K232084 — Stellaris Elite vision enhancement system
- K232628 — VADER® Pedicle System
- K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
- K233560 — Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
- K233675 — FMS VUE Fluid Management and Tissue Debridement System
- K234133 — Dexcom G7 Continuous Glucose Monitoring System
- DEN230025 — MIRA Surgical System
- K230423 — Electronic Peak Flow Meter
- K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System
- K232075 — StatStrip Glucose Hospital Meter System
- K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
- K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
- K232536 — Soldier Microcatheter
- K232800 — Navigation Tracking Instruments
- K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
- K233590 — Overjet Charting Assist
- K233709 — Exceed Unlimited
- K233722 — RADspeed Pro
- K233754 — AIO Breathe
- K233784 — ENSO (Model 2)
- K233995 — Ivotion Base Print
- K240011 — Lymphedema Compression
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K240201 — PathLoc SI Joint Fusion System
- K240212 — COGNiTiON Staple System
- K240213 — Iconix Knotless Anchor
- K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
- K223826 — NanoDrop Lancet
- K231875 — Vaginal Tactile Ultrasound Imager
- K231876 — MultiPulse HoPLUS
- K232074 — Serafin®
- K232163 — Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
- K232831 — Quiver Aspiration Pump
- K233544 — MESHEET
- K233640 — Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System
- K233749 — Revolution Ascend Sliding
- K233775 — Vivatmo pro
- K233996 — Ulthera System (UC-1 Control Unit PRIME)
Data sourced from openFDA. This site is unofficial and independent of the FDA.