FDA 510(k) clearances — page 147
clearances on record, most recent first.
Clearances — page 147
14,601–14,700 of 175,699- K213475 — Elevo Snoring Intervention Set
- K213489 — Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
- K213493 — Fortilink with TiPlus Technology
- K213771 — Merlin Aspiration System
- K202914 — SternaFuse Fixation System
- K210101 — American-Made Surgical Mask
- K211219 — LASSOSTAR NAV Circular Mapping Catheter
- K212610 — Surgical Face Mask
- K212771 — LightStim Elipsa
- K212868 — JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
- K212938 — Vitalograph Model 6000 Alpha
- K213591 — ANTHEM® Fracture System
- K213692 — SmoothSkin Pure Mini
- K201323 — INNO SLA Submerged Implant System
- K211355 — iCare HOME2
- K212173 — HDH Treatment Planning System
- K213347 — ADI Medical Surgical Face Mask
- K211482 — Disposable Syringe with Needle
- K212333 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
- K213639 — Revaclear 500, Revaclear 400, Revaclear 300
- K213780 — DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
- K210463 — Thermoplastic Elastomer (TPE) Hybrid Examination Glove
- K210810 — Steiking Packaging for Medical Devices
- K212111 — Myflon Surgical Mask Level 3
- K213970 — D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
- DEN200059 — POMC/PCSK1/LEPR CDx Panel
- K191105 — e-Throne Folding Wheelchair, Model: ET-12F22
- K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS
- K203761 — ParaMotion
- K211752 — Infrared Thermometer
- K211864 — Powder Free Nitrile Patient Examination Gloves, Blue Color
- K212594 — OSSIOfiber® Staple
- K212991 — Osteorevive
- K213044 — Nitrile Examination Gloves
- K213343 — Saremco Print CROWNTEC
- K213412 — VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
- K213470 — PERLA® TL Posterior Osteosynthesis System
- K213673 — b-ONE MOBIO Total Knee System
- K213696 — ETHICON Megadyne Electrosurgical Generator
- K214030 — Universal DR 1748
- K203161 — Surgical Face Mask
- K210259 — Parkell Self-Adhesive Cement
- K211333 — KIDNEY ASSIST-transport
- K212357 — Surgical isolation gown
- K212458 — Flexible Video-Uretero-Renoscope SSU System
- K212592 — Gas-Chex Indicator
- K212748 — Disposable Dual Action Tissue Clip
- K212884 — Electric breast pump
- K212941 — Porous Patella
- K213075 — Goody Gloves, Wincare, TBG Gloves
- K213356 — Entuit PEG, Entuit PEGJ
- K213668 — SIGNA Hero
- K213709 — SIGNA PET/MR
- K214019 — syngo.CT Extended Functionality
- K214084 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- K203072 — Franz Zirconia Dental Crown
- K210747 — Caption Interpretation Automated Ejection Fraction Software
- K211003 — SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
- K211330 — R3 Large Head Liners
- K211532 — Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
- K211613 — Stern Fix Sternal Stabilization System
- K211709 — Biotres
- K212012 — Follicle Clarity
- K212576 — MDx-Chex for BCID2
- K212581 — VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
- K212650 — Celeris, Disposable Sinus Debrider
- K212683 — GLOBAL ICON Stemless Shoulder System
- K212826 — Disposable Medical Mask
- K213227 — Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
- K213424 — Jabra Enhance Plus
- K213438 — 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
- K213447 — LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
- K214059 — CoreLink Navigation Instruments
- K201044 — CHIRANA Insulin Syringes
- K210679 — Medical Face Mask
- K212503 — HP458E Electrically Powered Wheelchair
- K212713 — Air compression leg massager HY-1117A
- K212842 — Microvolume Luer Access Device
- K213216 — Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
- K213572 — JuniOrtho Plating System
- K213781 — ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP
- K212994 — Medical Face Mask
- K211833 — Disposable Medical Face Mask
- K211980 — SIGNA Prime
- K213920 — Kangbeier Surgical Mask (Model: KBR-1001)
- K211360 — Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
- K212772 — Precision Align
- K201057 — Bio-Medicus Life Support Catheter and Introducer
- K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
- K203773 — BRM TOOL Screws
- K210466 — Silver Gelling Fiber Dressing
- K210760 — Precise Image
- K211254 — ARAI Surgical Navigation System
- K211632 — Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
- K211814 — Wellead Endoscopic Seal
- K212093 — Medline Universal Grounding Pad
- K212318 — IPL Hair Removal
- K212478 — Dermatological diode laser system
- K212913 — Surgical Face Mask
- K212997 — Surgical Mask
Data sourced from openFDA. This site is unofficial and independent of the FDA.