FDA 510(k) clearances — page 152
clearances on record, most recent first.
Clearances — page 152
15,101–15,200 of 176,479- K213671 — Astroglide Sensual Strawberry Personal Lubricant
- K213778 — IV Administration Set
- K213835 — TENS & EMS Device
- K220018 — MR Elastography; MZEK-001A
- K220379 — IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
- K201861 — Bio Fluff System
- K203376 — ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
- K210923 — Southern Implants Instrument Trays
- K211183 — Sugita AVM Microclips
- K212379 — N Latex FLC kappa, N Latex FLC lambda
- K212652 — Sterile Syringe with Fixed Safety Needle for Single Use
- K212698 — Plus Medical Isolation Gown Level 3
- K213127 — ReNew Disposable Scissor Tips
- K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
- K213279 — NovaGuide 2 Intelligent Ultrasound
- K213457 — Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
- K213551 — Giraffe Omnibed Carestation CS1
- K213553 — Giraffe Incubator Carestation CS1
- K213567 — Medline UNITE Calcaneal Fracture Plating System
- K213579 — Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
- K213932 — A-dec 300, A-dec 500
- K214091 — Dental Image Plate Scanner, Model DFC-4T-SMART
- K220006 — angioLOCK Polymer Ligating Clip
- K202046 — LOTA SLA Dental Implant System and LOTA HA Dental Implant System
- K210073 — Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
- K210074 — Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
- K210075 — Vigilant Software Suite Vigilant Master Med
- K210151 — Digimamo D
- K210811 — Dynamyx Digital Pathology Software
- K210848 — Sure-Fine Insulin Syringes
- K211484 — Disposable Sterile Syringe with Safety Needle +3 more
- K211776 — Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
- K211802 — GoBack Crossing Catheter
- K211868 — MYAH
- K212057 — Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
- K212187 — Restoration® Modular Hip System
- K212365 — BoneView
- K212596 — Sterile Latex Surgical Gloves Powder Free
- K212945 — Sterile Disposable Temperature Probe
- K213189 — Wrist-type Fully Automatic Digital Blood Pressure Monitor
- K213400 — Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
- K213590 — Blue Topaz Sacroiliac Screw System
- K220109 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
- K211661 — ENFit enteral syringes (NUTRIFIT)
- K212833 — Disposable Nitrile Examination Gloves
- K213635 — Vathin Video Bronchoscope System
- K213750 — VyLink Spinal Screw System
- K193406 — CardioChek Plus Test System; CardioChek Plus Home Test System
- K203113 — Masimo SedLine Sedation Monitor and Accessories
- K203150 — Cool-tip RF Ablation System E Series
- K203541 — Okamoto 002 Lubricated Polyurethane Male Condom
- K211711 — OmniTom Elite
- K211722 — Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
- K211855 — Ion Facet Screw System
- K212300 — Pulse Oximeter
- K212800 — PRIMA Humeral System and SMR Glenosphere Ø42
- K213043 — Levator Elite (Model LE9011)
- K213084 — Ear Thermometer, Model ET005, ET008, ET009
- K213241 — VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
- K213693 — MAGNETOM Vida with syngo MR XA50A
- K214066 — FEops HEARTguide
- K214097 — Explorer Air II
- K220217 — Normatec 3
- K220238 — Cohitech Cottonlock Tampons with Reusable Applicator
- K202845 — Bodygard SFS Surgical Gown Level 3
- K210135 — PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
- K211320 — CAPRI Corpectomy Cage System
- K211510 — uLab Systems Dental Aligner Kit
- K211645 — Epione
- K211798 — Cleaner Plus Thrombectomy System
- K212949 — Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use
- K213941 — Annalise Enterprise CXR Triage Pneumothorax
- K214094 — ROKI Surgical Mask
- K214100 — Luminice
- K220028 — NightOwl
- K220384 — ArtiSential Laparoscopic Instruments-Electrodes
- DEN210034 — ONE Male Condom
- K211965 — StimRouter Neuromodulation System
- K212378 — Arsenal Ankle Plating System
- K212668 — Sclerotherapy Needle
- K212786 — LevaLap Laparoscopic Access Device
- K213599 — SuperLine
- K213654 — NuVasive Reline Cervical System
- K214102 — Glidewell Appliance Resin, Hard/Soft
- K220003 — EzOrtho v1.3
- K220197 — Trigon HA Wedge Fixation System
- K211686 — Flexible Video-Choledo-Cysto-Ureteroscope System
- K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
- K213392 — INLIANT Surgical Navigation System
- K213991 — Enbio S
- K220471 — VALO X, VALO X Accessory Lenses
- K203548 — EndoArmor + Surgical Gown
- K213500 — TMG Nitrile Powder Free Examination Glove
- K213548 — Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
- K213724 — Medical Surgical Mask
- K220232 — Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
- K212366 — Heartland Health Surgical Mask
- K212863 — Surgical Face Mask
- K212935 — Air Pressure Foot Massager
- K212998 — Powder Free Nitrile Examination Gloves (White, Blue and Black)
Data sourced from openFDA. This site is unofficial and independent of the FDA.