FDA 510(k) clearances — page 76
clearances on record, most recent first.
Clearances — page 76
7,501–7,600 of 176,479- 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) +1 more
- K232989 — Pulse Oximeter (5 models)
- 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 +2 more
- K240536 — Wearable Breast Pump (Model S32)
- K240572 — Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10) +4 more
- K240801 — BioSonic US200 Ultrasonic Scaler (60034537)
- K241202 — Electric nasal aspirator (HTD2601US)
- K241598 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000) +3 more
- 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 +4 more
- 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 +3 more
- 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)
- K233579 — SC1 Handheld Ultrasound Imaging system (Model: SC1)
- K233840 — Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)
- K234059 — Forma Medical Optimal Plating System
- K240875 — Unity Knee PS-C Tibial Insert
- K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910)
- K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
- K232111 — NeoBeat, NeoBeat Mini
- K232640 — Venowave VW5
- K233006 — MyndMove, MyndMove 2.0
- K233368 — Allograft Delivery Device (OFAC-C)
- K240582 — VEA Align; spineEOS
- K240824 — Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
- K241035 — PMT Posterior Cervical Stabilization System (PCSS)
- K241158 — ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3
- K232952 — Copran Zri
- K233123 — SILKRO
- K233204 — Philips IntelliSite Pathology Solution 5.1
- K233288 — NLZ Built-In Motor System
- K233630 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2
- K240259 — APEX 3D Total Ankle Replacement System
- K241120 — Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
- K241144 — Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
- K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869) +1 more
- K232975 — Pulse Oximeter (MD300C228)
- K233096 — PRESSUREALERT® Pressure Monitoring System
- K233196 — Medihub Prostate
- K233230 — See Factor CT3
- K233240 — GERDX-System
- K233253 — eCARTv5 Clinical Deterioration Suite (eCART)
- K233259 — Xerosyn
- K233280 — SteadyTemp
- K233322 — Mochida Nerve Cuff
- K233326 — Merge Hemo, Model RCSV2
- K233361 — Sunny Cup and Applicator
- K233549 — Tempus ECG-AF
- K233876 — UNITY VCS (8065000296); UNITY CS (8065000297)
- K233885 — rainbow Paste Stain SE
- K234095 — OtoNova/OtoNova Pro
- K234155 — Nimbl (model PD08-N1)
- K240125 — Therm-X (Home); Therm-X (AT)
- K240387 — MINAMO blue; MINAMO viola
Data sourced from openFDA. This site is unofficial and independent of the FDA.