FDA 510(k) clearances — page 250
clearances on record, most recent first.
Clearances — page 250
24,901–25,000 of 176,542- K181948 — 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
- K182090 — AposTherapy System
- K182109 — REDAPT Modular Acetabular Shell
- K182179 — AdvantageRib Anterior System
- K182201 — Stratum Foot Plating System
- K182298 — hemochroma PLUS System
- K182562 — Hair Boom 69
- K182626 — OEC One
- K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
- K182958 — 1.5T 16ch Breast Coil
- K182980 — Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
- K173971 — K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent
- K180650 — Amsel Endo Occluder
- K180668 — Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
- K181292 — PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
- K181324 — FilmArray Pneumonia Panel plus
- K181689 — Nexcomp
- K181750 — SITZMARKS
- K181831 — IntelliVue Multi-Measurement Module MMX
- K181897 — Reprocessed Marinr Diagnostic EP Catheter
- K181985 — Voluson E6, Voluson E8, Voluson E10
- K181998 — CardioBand ECG Event Recorder
- K182182 — YUKON OCT Spinal System
- K182255 — CanGaroo Neuro Envelope (4 models)
- K182528 — Nitrile Glove Powder Free Black
- K183117 — PathLoc-L MIS Spinal System
- K172602 — Miracu
- K180463 — Apoller Flow Light Cure Flowable Composite
- K181090 — Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
- K181434 — SporView Rapid Read Biological Indicator SteamPlus Test Pack
- K181497 — HPM-6000UF
- K181829 — Velofix TLIF Cage
- K181850 — Inversa Implants
- K181886 — VivaSight-DL System
- K181963 — ostaPek Interbody Fusion Cages
- K182097 — React 71 Catheter
- K182101 — Riptide Aspiration System (React 71 Catheter)
- K182105 — JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant
- K182543 — Wearable Device; Cradle; Small Strap, Medium Strap, Large Strap; Multiple Device Charger; Hospital Starter Package
- K182603 — Z6 Diagnostic Ultrasound System
- K182604 — New Era
- K182653 — Voyant Maryland Fusion Device
- K182882 — CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
- K172792 — Handheld Pulse Oximeter, Model SP-20
- K180478 — RectalPro 75 Endorectal Balloon
- K181369 — Immucise Intradermal Injection System
- K182248 — Aspire Venting Tube
- K182508 — Saxxony Posterior Cervical Thoracic System
- K182598 — VersaLink Fixation System
- K182674 — Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
- K172907 — ELAN 4 Air Motor System
- K180395 — EZ-IO Intraosseous Vascular Access System
- K180966 — FilmArray Pneumonia Panel
- K181469 — Cryotop®US-flash and Cryotop®US-scoop
- K181559 — Neurosign V4 Intraoperative Nerve Monitor
- K181759 — PowerDot PD-01MT
- K181890 — Brainlab Compatible K2M Navigation Instruments
- K181992 — Heat Pain Pro
- K182083 — Catalys Precision Laser System
- K182195 — Arco-SA Lumbar Cage System
- K182338 — Blue Sky Bio Computerized Orthodontic Bracket System
- K182360 — Teleport Microcatheter
- K182481 — HEM-6410T-ZM Wrist Blood Pressure Monitor
- K182484 — VERITON CT whole body SPECT/CT system
- K182530 — BIOEASY Multi-Drug Test Cup
- K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe
- K182649 — Enteral Feeding Syringes with Enfit Connectors
- K182808 — Aspida® Anterior Lumbar Plating System
- K182857 — EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- K173917 — neoClose PDS
- K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
- K180631 — Silk Voice
- K180732 — MiroCam Capsule Endoscope System
- K180949 — Steribite
- K181590 — Neurostructures Cavetto® [MAX] Cervical Cage System
- K181684 — VAMP Plus Venous/Arterial Blood Management Protection System
- K181918 — CardioInsight Cardiac Mapping System
- K182030 — Faros Mobile
- K182166 — Wrist Blood Pressure Monitor Model BP4350
- K182329 — SureCure Orthodontic Aligner System
- K182462 — Exactech Alteon Highly Polished Femoral Stem
- K182472 — Cepheid Xpert GBS LB Control Panel
- K182838 — Geistlich Derma-Gide
- K172999 — uWS-MR
- K173001 — uWS-CT
- K180381 — Powder Free Vinyl Patient Examination Gloves
- K180683 — Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
- K182162 — OptiBond eXTRa Universal
- K182220 — Curbell branded Patient Monitoring Cables
- K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack
- DEN170049 — Innovo
- K172668 — W Zirconia Implants
- K173857 — Elecsys Tacrolimus
- K173916 — Finapres Nova Noninvasive Hemodynamic Monitor
- K180469 — ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
- K180838 — SaliPen
- K181613 — MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
- K181757 — Günther Tulip® Vena Cava Filter Retrieval Set
- K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System
- K181846 — ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.