FDA 510(k) clearances — page 54
clearances on record, most recent first.
Clearances — page 54
5,301–5,400 of 176,479- K250498 — BPS Wrist Fracture System
- K250514 — UPT Series Medical RO Water Treatment System
- K250439 — Catapult Guide Sheath +28 more
- K234012 — VITEK COMPACT PRO
- K241765 — PLANET Onco Dose (3.2)
- K241816 — VerteGlide Spinal Growth Guidance System
- K241960 — DeepRESP
- K242010 — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8 +1 more
- K242121 — mBôs (Monogram mBôs TKA System)
- K242244 — Viewer+
- K242323 — Maestro System (REF100)
- K242811 — BodyTom 64
- K243332 — Promisemed Safety Huber Needles
- K243353 — One-Fil Putty
- K243529 — Solution Administration Sets
- K243599 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)
- K243838 — NEXXT MATRIXX® SI System
- K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
- K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
- K250079 — Ruby XL System
- K250091 — KOROT Blood Pressure Monitor (KOROT P3 Accurate)
- K250267 — Visalys® Bulk Fill 1 x 4 g Syringe (15060) +5 more
- K250401 — AION TempShield
- K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
- K241811 — MedCAD® AccuStride System
- K242406 — SiOxC Cream
- K242997 — MY01 Continuous Compartmental Pressure Monitor
- K243487 — CryoFreeze Wart and Skin Tag Remover
- K243735 — Ziehm Vision FD
- K243788 — IceCap product line
- K243993 — Photon Therapy Apparatus (BL-10)
- K244022 — 308nm UV Phototherapy System (4 models)
- K250088 — FlowTriever2 Catheter
- K250113 — neoLaser Laser Surgery Fibers
- K250255 — xvision Spine system
- K250380 — Surgify Halo (5 models)
- K250382 — Freedom Total Knee System (All-poly Tibial Plate)
- K250385 — Turbo-Elite Laser Atherectomy Catheter
- K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005)
- K243746 — Delphi Amplifier
- K243763 — Wireless TENS & EMS Unit
- K243783 — Walking rehabilitation training electric wheelchair (ZW518)
- K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit
- K243849 — 2430TCA with Xmaru W
- K243903 — RCT600
- K243957 — PICOALEX
- K250411 — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
- K250605 — EVOL® ha Hyper C Cervical Interbody Fusion System
- K241562 — OutFlo Aortic Valve Dilatation Balloon Catheter
- K241725 — Better Diagnostics Caries Assist (BDCA) Version 1.0
- K242610 — 8mm Monopolar Curved Scissors (470179)
- K243029 — Origin TT Stem
- K250357 — RemunityPRO Pump for Remodulin® (treprostinil) Injection
- K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D) +8 more
- K250424 — Arthrex TightRope Soft Button, RT
- K241944 — AGILON® XO Shoulder Replacement System
- K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ) +1 more
- K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
- K243676 — Duet External Drainage and Monitoring System (EDMS)
- K243839 — Alteon® HA Femoral Stems
- K250188 — Wound Treatment System (VHT-200)
- K241159 — Handbike Batec Electric
- K241799 — ATMOS C 051 Thorax (317.0200.0) +10 more
- K242207 — NOABLE LASER
- K242338 — Cleerly LABS (v2.0)
- K242383 — Apex Locator
- K242510 — Geistlich Bio-Flow®
- K242642 — CuffTrek
- K242890 — SPINEART Navigation Instrument System
- K242914 — Op.n(TM) Navigation
- K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom
- K243515 — EpiWatch Monitoring System
- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
- K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon
- K243798 — Orthex External Fixation System
- K243801 — FRONT-LINE Field Sterilizer (FL135)
- K243970 — Portable Wheelchair
- K241767 — Versacem Acetabular Shell and Double Mobility HC Liners
- K241790 — XCELLARISPRO TWIST microneedling device
- K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP
- K243331 — LVivo Seamless
- K243578 — BEAR® (Bridge-Enhanced ACL Restoration) Implant
- K243587 — PureLift GLOW
- K243724 — Persona® Revision Knee System (Persona Revision SoluTion Femoral Components)
- K243842 — Intra-Operative Positioning System (IOPS®)
- K243871 — Philips IntelliSite Pathology Solution 5.1
- K250344 — BD Phoenix Automated Microbiology System
- K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- K241770 — Prostate MR AI (VA10A)
- K242149 — NovoSorb® MTX
- K242190 — Access Cortisol; DxC 500i Clinical Analyzer
- K242597 — CROSSLEAD 0.018inch
- K243751 — Mako Total Hip Application 5.0
- K250304 — TITANEX Screw Systems
- K232383 — iPhysio® System
- K241679 — Disposable Cytology Brush (AF series)
- K243461 — Calibrate Interbody Systems
- K243809 — Biolox® Delta Revision heads
- K243933 — Ceevra Reveal 3+
- K241947 — EnergyLounger (TY-01)
Data sourced from openFDA. This site is unofficial and independent of the FDA.