FDA 510(k) clearances — page 126
clearances on record, most recent first.
Clearances — page 126
12,501–12,600 of 176,479- 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) +2 more
- 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
- K222733 — Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
- K220774 — RobPath® Total Hip Application
- K220822 — 3D-SHAPER
- K220951 — PMT Facet Fixation System (PMT FFS)
- K221280 — Vesseal
- K221598 — Wearable breast pump
- K222086 — Inogen Rove 4 Portable Oxygen Concentrator
- K222117 — Swang-Ganz IQ pulmonary artery catheter
- K222242 — FloPatch FP120
- K222552 — 120V Neptune S Rover (0711-001-000) +3 more
- K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
- K222753 — SeaSpine 7D Navigation Instruments
- K222916 — US 450 Diode Laser Equipment
- K223193 — AIROS 8P Sequential Compression Device
- K223195 — AIROS 6P Sequential Compression Device
- K223275 — CELLO II Balloon Guide Catheter
- K223402 — HemosIL von Willebrand Factor Antigen
- K223403 — LIAISON Anti-HAV; LIAISON XS
- K211800 — Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
- K213210 — Oxygen Concentrator, Model JAY-5AW
- K220667 — Sleeved IC
- K220826 — LED Curing Light
- K221182 — Southern Transforaminal Lumbar Interbody Fusion (TLIF)
- K221444 — LED Eye Perfector, model: EY-36A, EY-36B
- K221862 — YY-A02-B Overlapped Compression Therapy
- K222038 — CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
- K222471 — IRRAflow Active Fluid Exchange System (AFES)
- K222750 — Yomi Robotic System
- K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K223112 — MAVERICK Mini External Fixation System
- K223239 — 8ch Wrist Coil
- K223487 — InkSpace Imaging Body Array
- K212567 — PVC Hydrophilic Urethral Catheter
- K213919 — Dexcom G7 Continuous Glucose Monitoring System
- K220772 — HydroMID 4F Single Lumen Midline Catheter
- K220843 — OAKTREE Anterior Lumbar Plate and Screw System
- K221626 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
- K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
- K221842 — Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
- K222441 — Ultrasound System 2300
Data sourced from openFDA. This site is unofficial and independent of the FDA.