FDA 510(k) clearances — page 208
clearances on record, most recent first.
Clearances — page 208
20,701–20,800 of 176,479- 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+
- K193591 — ARC 400
- K200010 — FilmArray BCID2 Control Panel M416
- K200251 — Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
- K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
- K200552 — EVOS Lumbar Interbody System
- K200696 — FIREBIRD SI Fusion System
- K191065 — Venus VivaTM
- K191762 — Magnetic Surgical System
- K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
- K192658 — Manual Wheelchair
- K192676 — Introcan Safety 2 IV Catheter 18-24 gauge
- K192988 — Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
- K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
- K200119 — LOGIQ E10s
- K200188 — DSI Dental Implant System
- K200524 — SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
- K200622 — Focus 43C detector, TRIMAX 43C detector
- K183086 — da Vinci X and Xi Surgical System
- K191860 — Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential
- K191868 — iCEWav Neuromonitoring Platform
Data sourced from openFDA. This site is unofficial and independent of the FDA.