FDA 510(k) clearances — page 41
clearances on record, most recent first.
Clearances — page 41
4,001–4,100 of 176,479- K250477 — NextAR(TM) Spine
- K250597 — REMEX Xcam6
- K250738 — YSIO X.pree
- K250843 — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)
- K251561 — Biograph Trinion
- K251574 — Sleep Watch
- K241990 — SpineSite Endoscope System
- K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
- K243534 — Micro Catheter
- K243919 — Voxel Dosimetry (00859873006226)
- K244007 — ArteVu
- K250127 — TSK Syringe
- K250724 — Intraosseous Infusion Needles
- K251060 — CORUS Navigation System-GX
- K251076 — Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
- K251234 — EnSite X EP System
- K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more
- K251361 — Tyber Medical Distal Radius Plating System
- K251706 — TENS and EMS Unit
- K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs)
- K252032 — T65 (9016E061-)
- K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor
- K243407 — Forcyte Autograft Harvest Kit
- K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS
- K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
- K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
- K250442 — da Vinci Surgical System, IS5000
- K250647 — SImmetry+ System
- K251350 — BD Plastipak Syringe
- K251364 — Sleepiz One+ (2.5)
- K251523 — Cios Spin
- K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
- K241183 — ISO Abutment
- K243489 — Alinity m EBV (09N43-095)
- K250652 — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
- K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
- K251220 — NUVENTUS NV.C Prosthetic Components
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K243244 — Heated Breathing Tube
- K243403 — BD Nexiva Closed IV Catheter System
- K250232 — Vathin® Video Bronchoscope System
- K250244 — Compression Therapy Device (LGT-2210DS)
- K250334 — Fusion Craniofacial Implant; Fusion Skull Implant
- K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF)
- K250970 — Marie
- K250989 — Stryker and Serf hip devices
- K251322 — Venue; Venue Go; Venue Fit; Venue Sprint
- K251339 — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
- K251620 — A.L.P.S. Proximal Humerus Plating System
- K251665 — Triathlon® Hinge Knee System
- K252033 — Profoject Disposable Syringe, Profoject Disposable Syringe with Needle
- K252215 — InbellaMAX System
- K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets
- K243711 — Confocal Microprobe Imaging System (10 models)
- K250284 — TSK SELECT Needle
- K250322 — Respond OC Conserving Regulator (130-0800)
- K251297 — MIS LYNX Conical Connection Implant System
- K251455 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K251618 — MOTO Partial Knee System Extension
- K251955 — Onflex Mesh
- K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
- K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
- K252010 — SPY Laparoscope
- K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- K242615 — Intermittent pressure compression system (Compression Pump PT1005A +2 more
- K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500) +4 more
- K243681 — Neuro Insight V1.0
- K243781 — HemoSphere Advanced Monitor (HEM1) +9 more
- K250280 — SD TL Implant System
- K250590 — MAGiC Sweep EP Mapping Catheter
- K250716 — IMAGE ONE
- K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- K251213 — Da Vinci Surgical System (IS5000)
- K251265 — Resilience Fully Covered Esophageal Stent System
- K251280 — DESS® Dental Implants
- K251748 — MammoSTAR Biopsy Site Identifier
- K243367 — Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
- K243415 — Granudacyn® Wound Irrigation Solution
- K243425 — Guided DAS Surgical Kit
- K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- K243566 — CardioTag
- K244018 — Disposable Biopsy Needle
- K250211 — Yushan X-Ray Flat Panel Detector
- K250686 — GyriCalc (Version 1.0.0)
- K250901 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- K251255 — LymphaTech Mobile 3D Measuring Tool
- K251300 — Plastic Surgical Kits
- K251310 — OTS 25-L (100-5)
- K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
- K251616 — Clear Miracle
- K251638 — Mobility Scooter (MS160C)
- K251564 — microINR System
- K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
- K231562 — ELEC ENGINE (Model: ISE-170L)
- K243404 — HyHub and HyHub Duo Vial Access Devices
- K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL)
- K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.