FDA 510(k) clearances — page 134
clearances on record, most recent first.
Clearances — page 134
13,301–13,400 of 176,479- K212751 — Powder Free Nitrile Examination Glove
- K221718 — Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
- K221887 — Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color
- K222294 — Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
- K222342 — Betel Gloves Nitrile Examination Glove Powder Free
- K222693 — Single-use medical latex examination gloves (LG100)
- K202144 — A.B. Dental Devices Dental Implants System
- K213339 — DENU Composite Resin, DENU Flow Resin
- K213759 — XACT Robotic System, ACE Model
- K220369 — Esthetic Colorant
- K220483 — Platform® Acetabular System
- K220941 — HotDog Temperature Management System
- K221481 — NeutrArt
- K221724 — Conductive Gel
- K221821 — ATEC IOM Accessory Instruments
- K221829 — Wet Flavored Personal Lubricants
- K222152 — 3M Attest Hydrogen Peroxide Indicator Tape 1228
- K222204 — Medical Surgical Mask
- K222265 — Diosculpt
- K222555 — reepot Nd; YAG laser system
- K222561 — Align
- K222568 — OptiCross 18 Peripheral Imaging Catheter
- K222877 — FREEPRINT crown
- K211605 — Dual Switch
- K212197 — WasherCap Fixation System
- K213674 — CellFX System
- K214125 — TRANBERG Thermoguide Therapy System
- K220089 — Disposable Polyp Snare
- K220540 — ProGrip Self-Gripping Polypropylene Mesh
- K220681 — Talee, Talee PostOP
- K222224 — SurgiLance® Safety Lancet
- K222253 — GlasIonomer FX ULTRA
- K222804 — Irrisept Antimicrobial Wound Lavage
- K210475 — EQ-M
- K212359 — PWD Negative Pressure Wound Therapy System
- K212615 — EpiFaith CV
- K213379 — Clearblue ® Early Pregnancy Test
- K220236 — V-Print dentbase
- K220607 — BD MAX Enteric Viral Panel
- K221179 — SomnoMetry
- K221214 — Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
- K221383 — MedtFine Blood Lancet
- K222059 — SpeediCath Flex Set
- K222293 — ArcSP Suprapubic Sling System
- K222542 — MCB UNIT Model: V10GMCBUS
- K213353 — Aorta-CAD
- K213598 — LUOFUCON Collagen Wound Dressing
- K214048 — Millipede 088 Access Catheter
- K214056 — Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
- K220359 — Tandry Compression Screw System
- K221227 — Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
- K221717 — Disposable Surgical Gown UM-148
- K221809 — DePuy Synthes 3.5mm Intrapelvic Acetabular System
- K221908 — JO CUMPLAY Personal Lubricant
- K221976 — Surgical Face Mask (Non-sterile)
- K222642 — Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
- K213013 — Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
- K213897 — Pro M Class
- K214060 — LANDMARK REBOA Catheter
- K220129 — Promisemed X-Safety Pen Needle
- K220839 — Arthrex Compression FT Pins
- K221638 — Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
- K221819 — 35g Standard SMMS Surgical Gown +6 more
- K221839 — Lancet
- K222121 — C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
- K222131 — NB 1 SA Implant System
- DEN220025 — Phagenyx System
- K202929 — Nexpowder
- K211027 — Altus Spine Pedicle Screw System
- K212217 — Tempo Smart Button
- K212926 — AllureTM Surgical Mask
- K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- K220297 — True Tulip, True M.I.S.
- K220339 — Esthetic Abutments Nobel Biocare N1
- K220441 — CYGNUS MoRe Anterior Cervical Plate System
- K220553 — Neuro Omega System, NeuroSmart System
- K220969 — GelPOINT V-Path Vaginal Access System
- K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
- K221194 — LEDEX
- K221249 — L1P-1F (TRIOS 5)
- K221343 — ECHELON ENDOPATH Staple Line Reinforcement
- K221534 — Surgical Face Masks (Ear Loops And Tie-On)
- K221676 — Exsalta
- K221799 — Electric Wheelchair, Model: 9000N
- K222155 — Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
- K222519 — ClearPoint System
- K203336 — Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
- K211204 — SafePort(TM) Manifold (or Stopcock)
- K213641 — MONDRIAN ALIF Cage with Supplementary Fixation Plate
- K213856 — Identity Shoulder System
- K220176 — Elecsys AFP
- K220697 — Nitrile Patient Examination Gloves, Powder Free
- K220830 — TrueBalance Surgical System
- K221089 — P12 Elite Series Digital Color Doppler Ultrasound System
- K221553 — Diamond Air+ (UI04A, UI04B, UI04C)
- K221597 — CO2 Laser System
- K221686 — NovoSorb Matrix
- K221966 — Dynamic TiBase
- K221968 — StageOne Shoulder Cement Spacer Molds
- K222468 — ArcTO Transobturator Sling System
Data sourced from openFDA. This site is unofficial and independent of the FDA.