FDA 510(k) clearances — page 125
clearances on record, most recent first.
Clearances — page 125
12,401–12,500 of 175,620- K221637 — Surgical Gown (Sterile); Surgical Gown (Non-sterile)
- K221918 — ReFlow System Mini
- K222005 — S.I.N. Instrument Kits
- K222353 — GM85
- K222383 — Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition
- K222605 — iFuse TORQ® Implant System
- K222687 — Digital Radiography CXDI-Elite, Digital Radiography E1
- K211902 — InnovaMatrix PD
- K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor
- K220081 — CORE-SPORT
- K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
- K221397 — MitraClip G4 Steerable Guide Catheter
- K221548 — Dental Air Polishing Handpiece
- K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condom
- K222316 — IPL Hair Removal Device
- K222328 — SteriCUBE® Multiple Tray Sterilization Systems
- K222329 — BriefCase
- K222442 — DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
- K222482 — AGILON XO Shoulder System
- K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K222627 — EndoGI S-Path Biliary Stent System
- K212561 — MTX-C1
- K213883 — NanoZoomer S360MD Slide scanner system
- K220342 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
- K220785 — Clean Connecting Tube
- K220831 — Dental Implantation Systems, Dental Electrical Motors
- K221211 — Infrared thermometer
- K221360 — Medline UNITE® Medial Malleolus Peg Plate System
- K221738 — NS-HGlio
- K222648 — 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
- K222661 — Digital Radiography CXDI-CS01
- K214015 — Palm NRG cellulite body device (model: Palm NRG body device)
- K220116 — Auryon Atherectomy Catheters
- K220795 — QT ECG
- K221062 — RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
- K221473 — Flowart
- K221631 — Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
- K222266 — Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
- K222602 — Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
- K222655 — OtoSight Middle Ear Scope
- K222629 — Resonic Rapid Acoustic Pulse Device
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.