FDA 510(k) clearances — page 154
clearances on record, most recent first.
Clearances — page 154
15,301–15,400 of 175,699- K203067 — Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
- K211199 — ST AIA-PACK BNP Assay
- K211356 — GIQuant
- K212068 — Biotech Dental Kits
- K212550 — Hura CTP v1.0
- K212787 — GT5 conductive & abrasive gel
- K212895 — Paragon 28 External Ring Fixation System
- K212956 — FDR Cross (DR-XD 3000)
- K212504 — Isolation Gown AAMI Level 3
- K212506 — Medical Examination Gloves (Tested for Use with Chemotherapy)
- K202110 — MStim Drop Model: LGT-233
- K202676 — Disposable Medical Face Mask
- K210253 — Best Glove-Latex Powder Free Examination Glove
- K210859 — NextAR Spine Platform
- K211055 — Microcurrent device (Model: HBR2-1)
- K211577 — SoftFix Balloon Trocar
- K211726 — Acuson SC2000 Diagnostic Ultrasound System
- K211817 — Anterion
- K211971 — Drug Relief v1
- K212044 — TrueLok Evo
- K212460 — Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
- K212485 — Disposable Nitrile Examination gloves
- K212502 — Resonic Rapid Acoustic Pulse Device
- K212523 — VFSS Pro Mobile Digital Imaging System
- K212551 — Nitrile Examination Gloves
- K212707 — CoolSculpting Elite System
- K212853 — Cervical Stand-Alone System
- K212896 — Visible Patient Suite
- K212900 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
- K210384 — CARESCAPE R860
- K210628 — X-FLO Fluid Management System
- K211103 — Powder Free Vinyl Examination Gloves
- K211288 — Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
- K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner
- K212019 — Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
- K212467 — Disposable Nitrile Examination Glove
- K212471 — Medical Face Mask
- K212496 — Ortho Aligner System
- K212510 — 7 Series Phototherapy Device
- K212511 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
- K212897 — IPL Hair Removal Device, model: AI01
- K212912 — OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
- K212937 — Dakota ALIF Plate System
- DEN200040 — OMNIgene GUT Dx
- K191964 — BD Kiestra IdentifA
- K201320 — Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
- K202732 — SOL-CARE IV Bag Safety Connector
- K203372 — SyMRI
- K210432 — LELTEK Ultrasound Imaging System (Model: LU700 Series)
- K210543 — IM007
- K210969 — Nulife
- K211544 — Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
- K211947 — GlideScope BFlex 2.8 Single-Use Bronchoscope
- K212084 — Fetal Doppler
- K212151 — FLUME catheter
- K212199 — ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
- K212404 — S.I.N. Instrument Kits
- K212446 — NuVasive Anterior Cervical Plate Systems
- K212515 — MOVIX DReamy
- K212537 — REAL INTELLIGENCE CORI (CORI)
- K210222 — Disposable Medical Mask
- K210473 — Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
- K210598 — Pediatric Nasogastric Feeding Tubes - Single ENFit Port
- K210777 — Powder Free Nitrile Patient Examination Gloves, Blue Color
- K210921 — TaiChiB
- K212306 — Tapestry Biointegrative Implant
- K213326 — VisionX 3.0
- K210499 — Alpha Dent Implants Dental Implants System
- K211079 — BioFire COVID-19 Test 2
- K211586 — Nitrile Examination Gloves (Blue, Violet)
- K212171 — Electronic Blood Pressure Monitor
- K212338 — SterileRight sterilization pouch and roll
- K212823 — DePuy CONDUIT LLIF Angled Inserters
- K212948 — Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
- K210588 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile
- K212403 — Tracheal Stent System (Y-Shaped)
- K201032 — Phoenix Digital Thermometer
- K201496 — N Latex FLC kappa, N Latex FLC lambda
- K210279 — Enbio S
- K210570 — TraumaGuard Intra-abdominal Pressure Sensing System
- K211064 — nView s1 with nav option
- K211161 — Critical Care Suite with Endotracheal Tube Positing AI algorithm
- K211987 — ATEC Alignment App
- K212308 — SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
- K212389 — Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
- K212831 — MectaLIF Extension
- K213163 — VersaWrap
- K213195 — Balloon BS-3
- K213264 — CARTO 3 EP Navigation System Version 7.2
- K213351 — ds Head 32ch 3.0T
- K200839 — APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
- K210287 — VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
- K211019 — Disposable Monopolar Laparoscopic Tips and Reusable Handles
- K211160 — EndoTool SubQ 2.1
- K211581 — Disposable Nitrile Examination Gloves (Powder free, Blue)
- K211797 — TRACKER Plus Kyphoplasty System
- K212290 — Examination gloves -Type C (Nitrile gloves)
- K212424 — AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
- K212489 — BonOs Inject Bone Cement; NEO Pedicle Screw System
- K201520 — The Alma Opus System, Colibri Applicator and Tips
Data sourced from openFDA. This site is unofficial and independent of the FDA.