FDA 510(k) clearances — page 130
clearances on record, most recent first.
Clearances — page 130
12,901–13,000 of 175,699- K220385 — Intense Pulsed Light Equipment
- K220403 — Vibe SF Self-Fitting Hearing Aid
- K220434 — Blue Eye (TS-905)
- K220680 — Denture Base Polymers
- K220835 — Arkligners
- K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
- K221049 — Zavation VariSync Plate System and VariSync Spacer System
- K221126 — Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets
- K221131 — Tasso+
- K221466 — IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
- K222082 — aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
- K222145 — EzDent-i / E2 / Prora View/ Smart M Viewer
- K210949 — Foundation Dermal Regeneration Scaffold (DRS) Solo
- K212361 — Novo
- K213713 — AI-Rad Companion (Pulmonary)
- K220050 — KLS Martin IPS Distraction
- K220308 — Patient Monitor: RespArray
- K220472 — NEUWAVE Microwave Ablation System and Accessories
- K220648 — OMF ASP System
- K220731 — Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
- K220910 — Medical image processing software
- K221177 — Erbe's Tubing/Cap Sets
- K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
- K221737 — InstaFill Graft Delivery System, SIGNIFY Bioactive
- K222161 — Arthrex Knotless FiberTak Biceps Suture Anchor
- K222414 — TERA HARZ DENTURE
- K212364 — BLT Dental Implant System
- K212763 — UniVit HE, UniVit UHS
- K213524 — CytonPro-5000
- K220056 — iSyncWave
- K220900 — Safety Blood Collection Needles with/without Needle Holder
- K221381 — KDG Abutments
- K221879 — Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
- K212482 — Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
- K213609 — NOVA RESIN dual cure, self adhesive resin cement
- K220077 — IMICRYL Composite, Composite Flow Materials
- K220241 — POINT Kinguide Robotic-Assisted Surgical System
- K221776 — NextGen Pedicle Screw System
- K221789 — IRIS Pi Q switched Nd YAG laser
- K222083 — LimFlow V-Ceiver
- K222357 — DenMat Glutaraldehyde Desensitizer
- K211675 — Dasky Disposable Sampling Tube (Model name: VSM02)
- K212243 — VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
- K213645 — ClearPoint Maestro Brain Model
- K213727 — dS Sentinelle Breast 16ch 3.0T Coil
- K213735 — dS Sentinelle Breast 16ch 1.5T Coil
- K221668 — Dental Impression Material
- K222072 — Dolphin Imaging 12.0
- K213934 — Pro Guard Nitrile Powder Free Examination Glove
- K221854 — Reprocesses Umbilical Cable
- K212810 — MONOFIX PGCL, knotless wound closure device
- K213791 — Unispace SA Cervical Cage
- K213876 — Spineology Navigation Instruments
- K213993 — Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
- K220045 — TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
- K220576 — FAMA Male Latex Condoms
- K221336 — Avéli
- K221350 — Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K221405 — Neurophet SCALE PET
- K211614 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System
- K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- K220303 — MDHearingAid app, MDHearingAid Smart hearing aids
- K220524 — Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
- K220887 — Mini-ClotTriever Thrombectomy System
- K221104 — Actera hip system
- K221124 — MANTIS Clip
- K221328 — Bloomi Smooth Water Based Lubricant
- K221628 — exGraft, exGraft Carbon
- K221952 — Endoscope Model EG-580UT and Endoscope Model EG-580UR
- K221953 — Masimo CARESCAPE SpO2 Masimo with SpHb
- K191131 — Solidence Multipockets
- K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
- K213477 — Root ZX3
- K213614 — Cannulated Screws
- K220139 — QScreen
- K221347 — Transpara 1.7.2
- K221432 — Customize
- K210179 — QOCA Portable ECG Monitoring Device
- K220032 — iStent infinite Trabecular Micro-Bypass System, Model iS3
- K220816 — BruxZir NOW
- K213929 — Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K220237 — Disposable Medical Nitrile Examination Gloves
- K220736 — Consolidated HC Steam Sterilizer
- K221451 — IPL hair removal
- K221549 — X-ray Flat Panel Detectors (CareView 1800 RF)
- K221616 — Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
- K221671 — CellFX® System
- K221773 — Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
- K202852 — DiviTum TKa
- K211370 — Tablo Hemodialysis System
- K211585 — Bodyport Cardiac Scale
- K212982 — Medispine - Spinal Needle, Glospine - Spinal Needle
- K213104 — Auxilock Titanium Screw-In Suture Anchor
- K213760 — ABMD Software
- K213911 — Microstream CO2 NanoPod
- K213914 — Injection Needle
- K220048 — NobelProcera Zirconia N1 Base
- K220331 — 091 Balloon Guide Catheter
- K220566 — Vascette HP (hemostatic pad)
- K220577 — Dental Handpiece, Model CA160, CA160L, and CA500L
Data sourced from openFDA. This site is unofficial and independent of the FDA.