FDA 510(k) clearances — page 113
clearances on record, most recent first.
Clearances — page 113
11,201–11,300 of 175,620- K223186 — Indigo® Aspiration System Lightning Bolt Aspiration Tubing
- K223263 — Prevena Plus 125 Therapy Unit
- K223370 — NeatNick Heel Safety Lancet
- K223387 — V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
- K223439 — SIGNA Victor
- K223656 — AmeriWater MediQA Reverse Osmosis System (MSP3HF)
- K223761 — OIC Intramedullary Screw System
- K223767 — Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
- K223779 — EMPOWR blade stem
- K223859 — Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
- K230196 — syngo.via View&GO VA40A
- K230207 — ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
- K213629 — SMILE
- K213853 — RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large
- K220435 — SEJONG Surgical Gown Soft
- K220657 — Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
- K220715 — ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
- K221452 — DiLumen C1, EZ1 and Tool Mount
- K221474 — PRIMUS Healthcare Sterilizer (Model PSS11-HC)
- K221476 — Perifit
- K222129 — Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
- K222513 — Glass Ceramics
- K222596 — S90 Exp Series Digital Color Doppler Ultrasound System
- K223194 — Glass Ceramic
- K223208 — Safety Lancet
- K223249 — Pro-Tx Endorectal Balloon (PROT-25)
- K223413 — Pisces-SA STANDALONE ALIF Interbody System
- K223425 — MD.ai Viewer
- K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications
- K223467 — Disposable Isolation Gown
- K223680 — Eneka Pro
- K223786 — Orthex External Fixation System
- K203211 — Insulin syringe with integrated needle DL
- K220505 — ATTIVA
- K221223 — extriCARE® 3000 Negative Wound Pressure Therapy System
- K221400 — hygh-tec drainage
- K221694 — External Drainage System
- K222041 — CYGNUS-C Standalone ACIF System
- K222073 — VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
- K223338 — Toothsi, Smilealigners
- K223559 — Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
- K223678 — Sterile Syringes for Single Use
- K230063 — G Surgical Marksman Spinal Deformity System
- K230073 — Okti
- K230089 — ETHICON LINX® Esophagus Sizing Tool
- K221472 — Filter and HME/Filter
- K222247 — Hailie Sensor NF0110
- K222685 — NIRA Model 2
- K223038 — Access Cortisol
- K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K222451 — SAVE GBR
- K222928 — Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System
- K223146 — EVOLUTION SPINE Interbody System
- K223686 — Medical Protective Masks
- K212701 — Eminent Spine 3D Cervical Interbody Fusion System
- K221531 — ClotTriever Thrombectomy System
- K221980 — Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
- K222398 — Care Team Portal
- K222955 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
- K223169 — Nerivio
- K223296 — Videa Perio Assist
- K223444 — Powder Free Blue Nitrile Examination Glove
- K223735 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
- K230095 — ScanX Swift 2.0, ScanX Swift View 2.0
- K230270 — 3M VitCal Liner/Base
- K222570 — COPAL knee moulds
- K222574 — Simparo Anchor Line Fixation System
- DEN220044 — Active Anthrax DetectTM Plus Rapid Test
- K213954 — BIOFIRE SPOTFIRE Respiratory (R) Panel
- K220296 — Manta Ray TDF Spacer
- K220337 — GaiaBone Bioabsorbable Bone Graft
- K220996 — Duoblade
- K221253 — SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
- K221348 — IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
- K221491 — Anivia SG1000 Pump Console
- K222063 — MONTAGE Settable, Resorbable Bone Putty
- K222153 — Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
- K222950 — AcuPebble OX100
- K223026 — NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
- K223051 — Pre-Formed Silicone Block
- K223395 — Luna Dental Implant System
- K223481 — VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
- K223648 — Cook® Spectrum® 2 MRC Central Venous Catheter
- K223679 — Access AMH
- K223876 — SMR Shoulder System
- K230051 — 14F iSLEEVE Introducer Set
- K230059 — Digital Flat Panel Detector
- K210751 — S.E.A.L. Hemostatic Wound Spray
- K213545 — Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
- K220126 — Geonic Nasal Aspirator, Geonic Nasal Cleaner
- K221356 — Wee Bell
- K221515 — StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
- K221781 — Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
- K222211 — Implant Direct Dental Implant Systems Portfolio - MR Conditional
- K222422 — Polaris Valve Electronic Reading Instrument
- K222671 — DeltaScan Patch
- K222680 — DeltaScan Monitor
- K222803 — Oncospace
- K223284 — SutureLoc Implant
- K223362 — Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.