FDA 510(k) clearances — page 117
clearances on record, most recent first.
Clearances — page 117
11,601–11,700 of 175,620- K222234 — GlucoSure ADVANCE Link Blood Glucose Monitoring System
- K222351 — inspired VHB20 Heated Humidifier
- K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
- K222586 — Mural Clinical Viewer
- K222637 — TriMed Wrist Fixation System 3
- K222864 — 8MP Color LCD Monitor CL-R813
- K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
- K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
- K223244 — Pristine Arthroscopic Visualization System
- K223482 — reVive Light Therapy® Wrinkle and Acne LED Device
- K213677 — Bonafix 2 Plus
- K220517 — IBS System
- K220991 — IntelliSep test
- K221004 — HOPKINS Telescopes
- K221011 — AI.ME System
- K221031 — Arthrex DualCompression Hindfoot Fusion Nail Implant System
- K221039 — Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
- K221070 — DP4 Microneedling device
- K221603 — Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI
- K221735 — Mineral Collagen Composite Bioactive Moldable
- K221775 — LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
- K221904 — EK12 V2 Algorithm
- K221926 — Invictus® Bone Cement, Invictus Spinal Fixation System
- K222308 — Al Smile Aligner
- K222358 — Indigo Aspiration System - Lightning Flash
- K222405 — Smart SPACE Shoulder Planner and 3D Positioners
- K222808 — Penumbra System (Reperfusion Catheter RED 43)
- K222896 — AirRay
- K223140 — AEON-C Stand Alone System
- K223294 — SpineJack® Expansion Kit
- K213196 — MARVEL Growing Rods
- K213653 — 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
- K214076 — EsCem
- K221351 — Mechanical Guidewire
- K221896 — BreathID Hp System
- K222213 — Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
- K222217 — ViewFlex Xtra Reprocessed ICE Catheter
- K222919 — GORE® ENFORM Biomaterial
- K220881 — INOUE BALLOON A
- DEN220012 — Tornier Pyrocarbon Humeral Head
- K212559 — CardioPhase® hsCRP
- K213110 — AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
- K213601 — Surgical Mask
- K213984 — Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
- K220010 — Daylily Single Use Sterile Embryo Transfer Catheter
- K220036 — Wellead Ureteral Catheter
- K220052 — Copan FecalSwab Collection, Transport and Preservation System
- K220281 — multiFiltratePRO System
- K220554 — Caduceus S
- K220928 — Overjet Calculus Assist
- K222275 — Saige-Density
- K222502 — KLICK (VARIANTS: POWER, RACE, MONSTER)
- K222608 — Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
- K222798 — Rejoni Intrauterine Catheter
- K222820 — BRM TOOL Screws, BIOPLAN Subtalar Implant
- K223153 — Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
- K223184 — Phantom Metatarsal Shortening System
- K223237 — SofWave System
- K223243 — BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets
- K223251 — Hexanium PLIF
- K223268 — BrainInsight
- K223334 — Sterile Hypodermic Needles for Single Use
- K214086 — Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
- K220520 — PM Excellence SEQUR 100 Surgical Face Mask
- K220591 — Proxima
- K220873 — Perceptive electric dental motor and control unit
- K220883 — Small Field Applicator
- K221102 — LOTUS Series 4 Enhanced Shears, LOTUS Series 5
- K221267 — VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
- K221453 — S.I.N. Dental Implant System
- K221555 — Dozee VS
- K222892 — Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
- K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
- K213722 — ICE Ceramics, ICE Stains, Fresco
- K220079 — Magicore Narrow System
- K220971 — QuikClot Control+ Hemostatic Dressing
- K221245 — PTA Balloon Dilatation Catheter
- K221800 — Infrared Thermometer (Model: Y20001, Y20002)
- K221891 — UNO Negative Pressure Wound Therapy System
- K221910 — QRS Dental Implants System
- K222527 — Nitrile Patient Examination Glove
- K222533 — Target Tetra Detachable Coils
- K222623 — Digital Crown
- K212071 — Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
- K213105 — Epilaser Absolute
- K214004 — CCBIO ASCPO Needle
- K220046 — Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
- K221318 — HVT 2.0
- K221342 — REDEMPTION Beaming System
- K222651 — Surgical Face Mask
- K222770 — Conductive Gel
- K223433 — Quantra QPlus System
- K202674 — Medidenta High Speed Handpieces
- K212957 — BioButton System
- K220921 — Metal Bone Screw
- K220926 — Spectra Wearable
- K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack
- K221642 — SIRIUS Endoscope System
- K223190 — Hive Standalone Cervical System
- K223510 — Matrix HA Fusion Porous Cervical IBF System
Data sourced from openFDA. This site is unofficial and independent of the FDA.