FDA 510(k) clearances — page 121
clearances on record, most recent first.
Clearances — page 121
12,001–12,100 of 176,479- K220276 — Infrared Thermometer TET-351
- K221043 — Doctor Tecar Plus, Doctor Tecar Smart
- K221483 — FlowSaver Blood Return System
- K221513 — Equashield Closed System Transfer Device
- K221645 — PROstep(TM) MIS 5mm Chamfer Screw System
- K222226 — EON
- K222588 — Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
- K222695 — troCarWash System
- K222971 — ULTRABUTTON QUAD Adjustable Fixation Device +4 more
- K222977 — DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip
- K223466 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101 +2 more
- K223497 — Spectrum Saliva Collection Device
- K223545 — APRO 70 Catheter and Alembic Aspiration Tubing
- K223798 — Glidewell TuffSplint Appliance Resin
- K223820 — EzDent-i / E2 / Prora View/ Smart M Viewer
- K223897 — Excipio LV Thrombectomy Device
- K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
- K213844 — Surgical Gown
- K220698 — Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
- K221784 — Single-use Video Pancreaticobiliary Scope, PB Digital Controller
- K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter
- K222622 — Disposable Infusion Bag for Parenteral Nutrition
- K222755 — uMR 680
- K223028 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
- K223056 — JAWS Nitinol Staple System
- K223327 — Sterile Aesthetic Cannula and Hypodermic Needle
- K223477 — PMMA Blocks for Dental Use
- K223478 — VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL)
- K223524 — IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
- K223733 — CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4
- K223766 — NUVISION NAV Ultrasound Catheter
- K223770 — Sonopet 1Q 3 7cm 1Q Large
- K223832 — Vivid S60N, Vivid S70N
- K230118 — Bony Trauma Extremity System (BTES) Screw Range, NX Nail
- K213669 — LIGHTSCALPEL LS-4020
- K221523 — Tanning Lamp
- K221874 — Altis Single Incision Sling System
- K222271 — Verisafe Safety sterile needles
- K222389 — ZEUS System
- K222869 — Arm Blood Pressure Monitor
- K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter
- K223046 — Xpert® FII & FV
- K223407 — Versana Essential
- K223815 — ONE DROP Lancing Device
- K223891 — Cobra Catheter System
- K230131 — ReShape Calibration Tubes
- K230175 — Digital Radiography CXDI-CS01
- K213757 — Endocem MTA Premixed Regular
- K221468 — Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants
- K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer
- K221527 — StitchKit
- K221672 — Creo Electrosurgical System with NP1 Instrument
- K223174 — X-Pac Expandable LLIF Cage System
- K223225 — 8ch T/R Knee Coil
- K212635 — Sofjec
- K213030 — Curiteva Porous PEEK Cervical Interbody Fusion System
- K221875 — Sterilization Pouch and Roll
- K222327 — Bloomlife MFM-Pro
- K222341 — Arrow 0.2 Micron Flat Filter, GVS
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.