FDA 510(k) clearances — page 68
clearances on record, most recent first.
Clearances — page 68
6,701–6,800 of 175,620- 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); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
- 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
- K240465 — O-arm O2 Imaging System
- K240631 — V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
- K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
- K240649 — Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
- K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
- K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
- K240862 — Medicom Sterilization Wrap
- K241117 — M6-C Single Use, Disposable Instrumentation
- K241442 — eZSURE Empty Fluid Container with ProSeal Injection Site
- K241459 — MOTUS PRO Family
- K241476 — ToxiSeal Vial Adaptor with External Flip Balloon
- K241519 — Invictus® Small Stature Spinal Fixation System
- K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- K232161 — DeepRhythm Platform
- K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
- K233158 — Copra Smile, Copra Supreme Hyperion
- K233162 — Freedom Peripheral Nerve Stimulator (PNS) System
- K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
- K240611 — IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
- K240613 — APTUS Elbow Dorsal Olecranon Plates
- K240642 — SMART Bun-Yo-Matic CT
- K240669 — ACTIFY 3D Total Knee System, ACTIFY Total Knee System
- K240673 — Electric wheelchair
- K240688 — RODIN Titan 3D Resin
- K240830 — Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System
- K241435 — Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue
- K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System
- K241627 — Safety Lancet (XXXV)
- K232997 — EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
- K233036 — Ultrasonic Surgical System
- K233294 — Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
- K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
- K233867 — Fitbone Trochanteric
- K240196 — Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
- K240552 — Irrisept Antimicrobial Wound Lavage
- K240583 — IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
- K240678 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
- K240774 — Pen Injector
- K241412 — Invisalign System
- K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
- K233060 — Elecsys Folate III
- K233255 — CROSSNAV Navigation Enabled Instruments
- K233256 — Robotic Integration Instruments
- K233324 — Molecular Transport Media - MTM
- K233331 — MediOMx
- K233987 — VERABAND
- K240684 — Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System
- K240747 — Medical Diode Laser (M2-GK)
- K241416 — Ion 3D
- K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
- K231116 — Multi-parameter detector
- K241469 — iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
- K230668 — Disposable High-pressure Extension Lines
- K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
- K232879 — Roche Digital Pathology Dx (VENTANA DP 200)
- K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
- K233043 — Smart Scope® CX
- K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
- K233228 — Spine Navigation and Robotic-Assistance Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.