FDA 510(k) clearances — page 113
clearances on record, most recent first.
Clearances — page 113
11,201–11,300 of 176,479- K231143 — GI Genius System 100 and GI Genius System 200
- DEN220027 — B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
- K220829 — Endo Motor
- K222356 — Claritag Advanced
- K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
- K223269 — Spencer Probe Depth Electrodes
- K223276 — Anchor Bolts as Accessories to Depth Electrodes
- K223645 — I.V. Administration Set, I.V. Extension Set
- K223725 — Restrata® MiniMatrix
- K230200 — Single-Use Flexible Ureteroscope
- K230432 — Single Use Bipolar Forceps
- K230453 — OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
- K230479 — ComASP Cefiderocol 0.008-128
- K230723 — C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
- K230758 — uMR 570
- K231113 — Arthrex FiberTak Suture Anchor
- K222728 — Radiation Planning Assistant (RPA)
- K223437 — Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
- K223696 — F&P Solo Mask Range
- K230286 — Assert-IQ Insertable Cardiac Monitor
- K230448 — DeepX DermoSight Dermatoscope
- K231102 — Symbia Pro.specta VA20A Family
- K231128 — JuggerKnot Soft Anchor
- K220964 — VERSAJET Hydrosurgery System (III)
- K222024 — Evita V800, Evita V600
- K222207 — Babylog VN800, Babylog VN600
- K222254 — Gunther Tulip Vena Cava Filter Retrieval Set
- K222560 — BlueCheck Caries Detection & Monitoring
- K222736 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- K222812 — Insufflator
- K222912 — c1Trac
- K223893 — Infrared Heat (Model: E0221)
- K230219 — Eminent Spine 3D Lumbar Interbody Fusion Systems
- K230262 — BruxZir Incisal Coloring Liquid
- K230358 — SAVI Dual (TM) Migraine Therapy
- K202993 — Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro) +1 more
- K220526 — HD+12, HD+15
- K222836 — Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
- K223836 — Vathin® Video Bronchoscope System
- K230121 — Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) System
- K231391 — Combi Touch
- K223147 — myLEDmask
- K223308 — HEATING TENS/EMS, FT-810R
- K230217 — Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
- K221969 — IU Implant System Abutment
- K222106 — Waypoint GPS
- K222460 — Intraoperative Ultrasound Probe Cover
- K222489 — Harvest Printable Resin
- K222854 — iTFlow
- K223101 — BD Secondary Infusion Set
- K223706 — PMMA BLOCK
- K230394 — EUROSCREW NG; EUROSCREW TCP NG
- K230414 — ClariVy Cervical IBF System
- K230684 — RadiForce MX217
- K230975 — Ahmed® Glaucoma Valve Model FP7
- K231051 — Ahmed® Glaucoma Valve Model FP8
- K231063 — SOMAVAC® 100 Sustained Vacuum System
- K231190 — EPIQ Series Diagnostic Ultrasound System
- K231224 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K220721 — FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
- K222501 — Regeneten Bioinductive Implant
- K222549 — OpenTex
- K223265 — CryoX Vitrification Freeze Kit / Thaw Kit
- K223623 — SubtleMR (2.3.x)
- K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
- K230550 — JAWS Nitinol Staple System
- K231052 — ExacTrac Dynamic 1.1.2
- K220437 — Neurophet AQUA
- K221127 — Sientra, inc. Portfinder
- K222870 — Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
- K222987 — Akunah REFLECT
- K223044 — Digital Thermometer (Model QT001)
- K223318 — Internal Joint Stabilizer - Elbow
- K223624 — Emerald Herbst
- K230491 — HandX Monopolar Scissors
- K231032 — AMP by Method Mobility, AMP Plus (or +) by Method Mobility
- K231338 — 3M Clinpro Clear 2.1% Sodium Fluoride Treatment
- DEN220083 — Stanza
- K212857 — Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
- K222436 — Latitud Hip Replacement System
- K222484 — Retitrack
- K222719 — CX50N
- K223015 — STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
- K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- K223025 — Tyvek Roll with CI for STERLINK Sterilizer
- K223335 — SIRION Lateral Lumbar Interbody System
- K223655 — Catalyst R1 Reverse Shoulder System
- K223825 — Tens & Ems Device
- K230721 — ATEC Lateral Plate System
- K222487 — Anika Tissue Tack Fixation System
- K222716 — MX50N
- K223280 — Disposible Nitrile Gloves
- K223428 — Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
- K230674 — JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
- DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
- DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
- K202963 — ELEC Master, ELEC Master Dual
- K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
- K221768 — Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
Data sourced from openFDA. This site is unofficial and independent of the FDA.