FDA 510(k) clearances — page 144
clearances on record, most recent first.
Clearances — page 144
14,301–14,400 of 176,479- K220488 — Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K220650 — TriMed Ripcord Device
- K220973 — CoreLink Navigation Instruments
- K221002 — IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
- K221264 — FROG Forceps Valve (VAL1-F1-100)
- K203771 — Urea Nitrogen2
- K210987 — IRRIGO Wound Wash Jet System
- K211571 — Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
- K212680 — LuxCreo Clear Aligner System
- K212699 — Disposable Powder Free Polyethylene Examination Gloves
- K212729 — Bone Cement-Normal Viscosity
- K213065 — Distal Access Catheter
- K213341 — Fibrillar Collagen Wound Dressing
- K213731 — EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
- K214096 — Respire Clear
- K220113 — Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
- K220766 — eMurmur Heart AI
- K221248 — Rapid LVO
- K221270 — EchoNavigator R4.0
- K221440 — Liverty TIPS Access Set
- K212584 — Blue Nitrile Examination Gloves Powder Free
- K212597 — Amazing+ Latex Examination Powder Free Gloves
- K213141 — Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
- K212268 — FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
- K212669 — Single Use Hemoclip
- K212838 — Benchmark Intracranial Access System
- K212873 — Aspire Cristalle
- K213698 — CoLink PCR Plating System
- K220146 — VisAR
- K220557 — MoistureMeterD Compact, LymphScanner
- K220593 — Spine Guidance Software, Stryker Q Guidance System
- K220609 — Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
- K220610 — SOLO-L
- K220889 — Senhance Surgical System
- K220902 — Navagio Lumbar Cage
- K210633 — Amylase2
- K211779 — ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
- K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K212413 — I-Motion
- K212629 — PP Care Nitrile Examination Gloves
- K212644 — Aura Storm
- K213027 — Laser Hair Growth Comb
- K213171 — Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
- K213221 — AMADEO, M-UK1015 (incl. attachments and accessories)
- K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K214074 — Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
- K220195 — iFuse Bedrock Granite Implant System
- K220249 — Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
- K220355 — Astroglide Ultra Gentle Gel
- K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
- K220596 — Wearable Breast Pump (Model S9)
- K220597 — Disposable Surgical Face Mask (FM-34EE,FM-44EE)
- K220641 — Barrigel Injectable Gel
- K201393 — restor3d MTP Implant
- K202920 — OptiComp
- K203661 — CRYO Arctic, CRYO Penguin
- K210655 — Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
- K210748 — Well-life TM Pen Needles, Well-life TM Safety Pen Needles
- K211652 — Renuvion Dermal Handpiece, Renuvion Dermal System
- K211953 — Disposable Sterilized Latex Surgical Gloves
- K213039 — Micro-current facial cold and hot service (model: TPML-100)
- K213485 — Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
- K214046 — 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
- K220065 — Single Use Ureteral Access Sheath
- K220083 — LDV((Low Dead Volume )Syringe
- K220200 — Paltop Conical Implant System
- K220350 — KardiaMobile 6L
- K220416 — SwiftMR
- K220481 — Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
- K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
- K220793 — InnoVoyce Laser Fiber
- K221180 — Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
- K221244 — CD Horizon Spinal System
- DEN200062 — Parsortix PC1 Device
- K210614 — BENCOX Mirabo Z Cup Cortinium
- K212327 — M-Vizion Monobloc
- K213191 — S-Line
- K213481 — Medline General Surgery Tray
- K213659 — LigaPASS 2.0 Ligament Augmentation System
- K220191 — Disposable Face Mask
- K220888 — MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
- K220952 — MY01 Continuous Compartmental Pressure Monitor
- K221215 — e-motion M25
- K200788 — Assure Titanium Blood Glucose Monitoring System
- K211810 — Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
- K211878 — LiquiBand XL
- K212563 — CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
- K212803 — DailyMate Orthodontic Aligner System
- K212988 — ONO Retrieval Device
- K213402 — Triever24, Triever20
- K213829 — SCENARIA View
- K220155 — Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
- K220470 — Smart Wireless Stethoscope
- K220507 — 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
- K220532 — Disposable surgical mask
- K220564 — 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355
- K220867 — Tapestry Biointegrative Implant
- K221000 — ON3D
- K210545 — Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
- K211256 — Disposable Sampler Viral Transport Media
Data sourced from openFDA. This site is unofficial and independent of the FDA.