FDA 510(k) clearances — page 200
clearances on record, most recent first.
Clearances — page 200
19,901–20,000 of 175,699- K193369 — Xelis Dental 2.0
- K200388 — Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
- K200403 — Stat Profile Prime Plus Analyzer System
- K200703 — JiveX
- K192167 — CuraRad-ICH
- K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
- K192850 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
- K193464 — ND:YAG Laser
- K200099 — s-Clean SQ-SL Implant System Mini
- K200215 — ADVIA Centaur CEA Assay
- K200300 — VivAer Stylus
- K200726 — AcuityPDR
- K200665 — VERASENSE for Stryker Triathlon
- K193275 — Nerve and Muscle Stimulator
- K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
- K192679 — Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
- K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K193282 — SIGNA Premier
- K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
- K200044 — SkinStylus SteriLock MicroSystem
- K200072 — KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
- K200078 — VARO Plan
- K200112 — Zimmer Hip Joint Replacement
- K200642 — OrthAlign Plus System
- K200644 — ACUSON Freestyle Diagnostic Ultrasound System
- K200668 — DR-ID 1200SDK System
- K191574 — OxSAT 100
- K191867 — ATLAS Plating System
- K191935 — Nautilus Smart ECMO Module
- K192138 — Rejuvapen NXT
- K193104 — Unified Arrhythmia Diagnostic System PocketECG IV
- K193329 — PreXion3D Explorer EX
- K193640 — ClearCalc
- K200001 — MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
- K200052 — CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
- K200326 — Powder Free Nitrile Examination Glove (Aqua Green)
- K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System
- K200517 — Standard Trocar
- K200539 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
- K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
- K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
- K200688 — hyperion X5, NewTom GO, X-RADiUS COMPACT
- K200713 — EchoNavigator
- K191885 — Standard Bougie
- K192108 — Panthera Dental Milled Bars
- K192636 — TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
- K193300 — AIMI-Triage CXR PTX
- K193571 — Go2Wire Guide Wire
- K200144 — HI-TORQUE Steelcore Bare Guide Wire
- K200282 — Orfit Aerial Couchtop
- K200411 — Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
- K200477 — Flex Body Speeder
- K200598 — Voyant Maryland Fusion Device
- K200632 — TCAT TKA Instrument Tray Set
- K191084 — The Optimotion Blue Total Knee System
- K192013 — VERTICALE® Cervical System
- K193218 — Innovision Audio
- K193654 — BlueStar Rx
- K200266 — BD Centro Vena Acute Central Line (7 French Dual Lumen)
- K200339 — HS40 Diagnostic Ultrasound System
- K191422 — Neural Navigator
- K191970 — Diode Laser Hair Removal System
- K192401 — Straumann Screw-Retained Abutments
- K192500 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
- K192558 — Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
- K193217 — SensiCare PI and SensiCare PI Micro Surgical Gloves
- K193250 — Irrigation Tubing with CO2 or Air
- K193494 — Origin Anterior Cervical Plate System
- K200019 — Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
- K200023 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- K200025 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K200199 — ADVIA Centaur CA 125II
- K200204 — Stat Profile Prime Plus Analyzer System
- K200308 — MTS Lefamulin 0.016- 256 µg/mL
- K200312 — Tryptik Ti
- K200361 — Akros Scruture Anchor LisFranc Repair Kit
- K200576 — ClearMask Transparent Surgical Face Mask
- K200776 — Eko CORE
- K192015 — Faico Dental Implant System
- K192719 — Osom Ultra Plus Flu A&B Test Kit
- K192735 — Diode Laser Hair Removal Machine
- K193026 — Visera Elite II Video System Center, Visera Elite II Endoeye 3D
- K200022 — FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
- K200564 — Aria System
- K200566 — ADAPT Tissue
- K200577 — RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K200608 — Eclipse Treatment Planning System v16.0
- K200638 — LAP-iX Suction Irrigation
- K192006 — SIRION Lateral Lumbar Interbody System
- K192099 — MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
- K192101 — Medone Ultra, Medextra
- K192176 — IntelePACS
- K192445 — QwikCheck Chemical Indicators
- K192514 — Patient Monitor
- K192646 — SYMPHONY OCT System
- K192958 — TwitchView System
- K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
- K193095 — Ambu aScope 4 Cysto
- K193322 — NovaCross CTO Microcatheter
- K193390 — CS Model+
Data sourced from openFDA. This site is unofficial and independent of the FDA.