FDA 510(k) clearances — page 275
clearances on record, most recent first.
Clearances — page 275
27,401–27,500 of 175,699- K160405 — OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
- K162662 — GingiDent Gingival Retraction Paste
- K163623 — Quantra
- K163713 — Sofia Lyme FIA, Sofia Lyme Control Set
- K170106 — MyKnee PPS-Pin Positioners
- K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
- K170371 — DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
- K170671 — SafeSept Transseptal Guidewire
- K171052 — Ultimate Contour, Ultimate Contour Mini
- K171206 — D'Vill Introducer
- K171257 — ClearPoint System
- K171594 — Accuro
- K171709 — BR-FHUS Viewer 1.0
- K171987 — Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
- K172027 — Adani MammoScan
- K172090 — GuideLiner V3 Catheter
- K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
- K172352 — TREFOIL System
- K172403 — GSI Novus
- K172869 — Discovery XR656 HD
- K172881 — NeuroBlate System
- K173052 — Heraeus TMW Guidewire
- K162216 — GRI-FILL PERISTALTIC SET
- K170261 — Premium Plus Prophy Air Motor
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
- K170453 — Medrobotics Flex Robotic System
- K170614 — CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
- K171014 — VICTUS Femtosecond Laser Platform
- K171243 — audifon Tinnitus-Module
- K171672 — 065 Zenith, 074 Zenith
- K171774 — RPM Reinforced PTFE Mesh
- K172079 — Avail
- K172281 — PuRE PMMA Disc
- K172376 — Discovery Pico, Discovery Pico Plus
- K172527 — Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
- K172811 — EsophyX Z, EsophyX2 HD
- K170298 — Liberator Beacon Tip Locking Stylet
- K171017 — Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
- K171068 — OrthoView 7.2
- K171125 — Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
- K172034 — Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
- K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
- K172297 — NovaCross Microcatheter
- K172608 — Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
- K172801 — ECG SENTINEL System
- K172809 — OTC Combo TENS/EMS System
- K172910 — Emit II Plus Oxycodone Assay
- K172940 — ANCHOR Tissue Retrieval System
- K173101 — Curve Image 2.0 PACS
- K160282 — SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
- K170538 — RVS-100 Vital Signs Monitor
- K170834 — CERABIEN ZR
- K171752 — X-SURGE
- K172179 — Chitogel Endoscopic Sinus Surgery Kit
- K172198 — 585
- K172493 — EnsoETM
- K172728 — Applanation tonometer AT-1
- K172806 — Bencox Mirabo Cup System
- K172817 — 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
- K162042 — OptiScanner 5000 Glucose Monitoring System
- K170819 — AcQMap 3D Imaging and Mapping Catheter
- K170948 — AcQMap High Resolution Imaging and Mapping System
- K171879 — HylaGuard Moisturizing Cream
- K171974 — Solana RSV+hMPV Assay
- K172186 — BioWick X Implant with Driver
- K172487 — Coaxial Dilator Set (Micro-Introducer)
- K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
- K162362 — PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
- K163277 — SuperNO2VA Device
- K163653 — NOVOS-NAIL Limb Lengthening System (LLS)
- K163696 — SleepImage System
- K170151 — Electronic Blood Pressure Monitor
- K170232 — AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
- K170233 — Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
- K170241 — GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System
- K171015 — Citryte
- K171120 — Senhance Surgical Robotic System
- K171286 — PAL Multi-Use Cannulas and PAL Manual Wand
- K171548 — Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
- K171702 — Exciplex308nm
- K171916 — Single Use Hot Biopsy Forceps FD-231
- K172023 — CELFIRM
- K172181 — micro IPL
- K172197 — SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
- K172435 — Galaxy R Digital Radiography Upgrade
- K172454 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL
- K172498 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
- K172772 — Freemie Independence, Freemie Liberty
- K172784 — DX-D Imaging Package
- K170085 — SONON Ultrasound Imaging System, Model: 300L
- K170146 — Galaxy UNYCO System
- K170147 — Lucica Glycated Albumin-L
- K170154 — Creavo Vitalscan Magnetocardiograph
- K170840 — MAGNETOM Terra
- K171169 — Aquarius 8600 1417TG and Aquarius 8600 1717TG
- K171279 — Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
- K171497 — Mikron Spinal Fixation System
- K171782 — Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
- K171796 — Vial Adapter 15mm
Data sourced from openFDA. This site is unofficial and independent of the FDA.