FDA 510(k) clearances — page 67
clearances on record, most recent first.
Clearances — page 67
6,601–6,700 of 175,620- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)
- K234084 — STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)
- K240120 — Merlexi Craft Bariatric series of manual wheelchairs
- K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
- K241111 — AMT Suture Passer
- K241305 — LifeRay Intraoral Handheld X-ray System
- K241625 — Anatase Navi Disposable Instrument
- K241649 — DUO1 and DUO2
- K241660 — SiOxD® Wound Matrix
- K233574 — Total Wrist Arthroplasty System (TWA)
- K240009 — iQFlex Pro
- K240052 — Disposable Enteral Feeding Sets
- K240946 — Gastric Alimetry
- K240987 — Access sTfR
- K240996 — Access Thyroglobulin Antibody II
- K241129 — Upper Arm Electronic Blood Pressure Monitor
- K241277 — OSSIOfiber® Threaded Trimmable Fixation Nail
- K241284 — da Vinci Surgical System (IS5000)
- K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
- K241508 — SKOUT® system
- K241577 — Iconix® Anchor
- K241591 — Blue Eye
- K241600 — Dermablate
- K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
- K241615 — Transducer Probe Cover
- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
- DEN240013 — MagDI System
- K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
- K233415 — DELTAWAVE Nasal Pillows System
- K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
- K233626 — AOS Marker Seeds (SMG0242-025)
- K234074 — Next Generation Access Catheter
- K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
- K240555 — Tyto Insights for Crackles Detection
- K240707 — Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
- K240736 — SMART Bun-Yo-Matic X-Ray
- K240863 — Freedom® Total Knee System
- K240915 — ZIEN IO Intraosseous Access System
- K240930 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue
- K241300 — ViewPoint 6
- K241330 — Fogarty Fortis Arterial Embolectomy Catheter
- K241574 — iFuse TORQ® Implant System
- K241622 — Extended Reservoir; MiniMed Reservoir
- DEN240007 — BioHealx Anal Fistula Device
- K231015 — Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
- K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
- K232989 — Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)
- K233477 — Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
- K233908 — cNeuro cDAT
- K234061 — StarFormer
- K240070 — Profound Matrix
- K240221 — SPECTRALIS HRA+OCT and variants
- K240353 — Hyper Insight - ICH
- K240477 — Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
- K240536 — Wearable Breast Pump (Model S32)
- K240572 — Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6)
- K240801 — BioSonic US200 Ultrasonic Scaler (60034537)
- K241202 — Electric nasal aspirator (HTD2601US)
- K241598 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500)
- K241639 — Single-use Video Ureterorenoscope (SVU-220US)
- K232865 — Magseed Pro Magnetic Marker System
- K233637 — Cordis BRITECROSS Support Catheter
- K233823 — Ultrasonic Fetal Doppler
- K240164 — NovaLine SP-C35 Transducer Protector (956007)
- K240215 — BLUE 400; BLUE 400 S
- K240320 — Patient Monitor (RespArray)
- K240892 — XSense Cryoablation System with Cryoprobes
- K240893 — ARTFX MEDICAL Cervical PEEK Cages
- K240927 — Access Thyroglobulin
- K241154 — Electric Wheelchair (YFWB-63)
- K241204 — TopCEM-Veneer Light Cure Veneer Cement
- K241229 — Hello,eyes® BIO Plug
- K241406 — Lavieen
- K241540 — NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter
- K241608 — nordicMEDiVA
- DEN230055 — FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System
- DEN240016 — Xpert HCV; GeneXpert Xpress System
- K233357 — EsoCool Thermal Regulation Catheter
- K233398 — Faros Surgical System
- K233762 — SteroScope® Sterilization Technology System
- K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
- K240327 — UNIKO PointCloud Knee Instruments
- K240381 — CATALYSTEM Femoral Stems
- K240564 — NuFACE® FIX+
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K240823 — els extra low shrinkage® composite & els extra low shrinkage® flow
- K240853 — Pathfinder® CR System
- K240938 — The Optimotion Blue Plus Knee System
- K241212 — MagnetOs Easypack Putty
- K241506 — Annabella Double Breast Pump (ADO-US23-1000)
- K241509 — TENS&EMS units (SM9109A, SM9109B)
- K241520 — Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
- K241542 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)
- K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
- K222771 — Sample Preservative Fluid
- K232829 — Versalock Rib and Sternum Plates System
- K232987 — FlowArt Valve for Vial Access
- K233354 — WVSM Pro (Series) (500-0030-XX)
- K233380 — TRIDENT Mobile Fluoroscopy System
- K233413 — Ultraphon Chemical Indicator (TRO-T and TRO-B)
Data sourced from openFDA. This site is unofficial and independent of the FDA.