FDA 510(k) clearances — page 48
clearances on record, most recent first.
Clearances — page 48
4,701–4,800 of 175,620- K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- K243702 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
- K243907 — Affixus Tibial Nailing System - 4mm screws
- K243961 — Electrically Powered Wheelchair
- K243962 — Electrically Powered Wheelchair
- K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
- K241462 — LONGY Implant and LONGY-N Implant
- K241634 — Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
- K241817 — InSet Total Shoulder System
- K241897 — MOR
- K243155 — Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
- K243188 — CYLOX® ST
- K243317 — NUVENTUS NV.C Surgical Cassette and Tray
- K243518 — BinaxNOW COVID-19 Antigen Self Test
- K243620 — Vivid iq
- K243628 — Vivid T9/Vivid T8
- K250200 — InbellaBody System
- K240958 — Locking Plates and Screws Systems
- K241516 — BTL-398
- K241659 — Ultrasound Workspace (UWS 6.0)
- K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL
- K243063 — Myolight Microcurrent Handpiece
- K243201 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
- K243453 — Philips Lumea IPL
- K243511 — OTC TENS & EMS Unit
- K243516 — Remi Custom Night Guard
- K244042 — Calcium2
- K241453 — Elecsys sFlt-1 and Elecsys PlGF
- K241483 — ceramys femoral head system
- K242368 — Symani Surgical System
- K242404 — BDC Dental Unit
- K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System
- K242713 — Any-Com Bulk
- K242957 — Identify (4.0)
- K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F)
- K243661 — Electronic Blood Pressure Monitor
- K243780 — HELIOS 785 Pico (1754V2)
- K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
- K241599 — Signature Osteosynthesis Plate System
- K241702 — CROSSLEAD 0.014inch
- K242111 — VIVACE
- K242192 — Disposable Sphincterotome
- K242324 — DUTAU-NOVATECH®
- K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
- K242580 — Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
- K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
- K243243 — Delphi MCS Electrode Cap
- K243465 — Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
- K243488 — VMAT PRO
- K243784 — Stryker Orthopaedics Hip Devices Labeling Update
- K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K243817 — Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert
- K244034 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
- K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
- K250055 — BPS - Bone Fragment Fixation Plates, Screws and Washers
- K250061 — Celerity Incubator
- K250066 — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
- K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial
- K241488 — TrainFES Advance
- K241593 — BoneMetrics (US)
- K242352 — Accurate Mini Non-invasive blood pressure monitor (AMB-001)
- K242896 — Caliber Intramedullary Fixation System
- K242983 — CROMA Electrosurgical Generator (PRD-EMR-050)
- K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
- K243580 — GraftGun Universal Graft Delivery System (GDS)
- K243790 — GRYPHON X Anchor; HEALIX TRANSTEND Anchor
- K242916 — Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
- K243138 — Geon (S2) Nasal Aspirator
- K243333 — rTOP
- K250068 — Venclose digiRF Generator (VCRFG1)
- K240402 — Cito CBC System
- K241368 — Sonicaid Team3
- K241375 — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
- K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
- K241590 — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
- K243146 — iCare APP
- K243182 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
- K243268 — TipTraQ (TTQ001)
- K243393 — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
- K243908 — Tiger 2 System
- K250035 — Contour ProtégéAI+
- K241193 — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,
- K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- K241694 — ZeTTA PACS
- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K242442 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
- K242982 — Mobility Scooter (MS160A)
- K243150 — Nuance Audio Hearing Aid Software
- K243441 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
- K243572 — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
- K243665 — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
- K243742 — Arthrex DynaNite Nitinol Staples
- K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
- K233956 — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
- K241270 — BTL-754
- K241292 — MyShoulder Planner (5.3SSWPL)
- K242568 — Wrist Blood Pressure Monitor (OHMS11, OHMS12)
Data sourced from openFDA. This site is unofficial and independent of the FDA.