FDA 510(k) clearances — page 157
clearances on record, most recent first.
Clearances — page 157
15,601–15,700 of 175,699- K212114 — Elekta Unity
- K212201 — PENTAX Medical Auto Leakage Tester SHA-P6
- K212414 — OSSDSIGN Cranial PSI
- K212433 — Anthem Fracture System
- K212813 — Zenition 70
- K212828 — BRIUS Planner Software
- K191288 — Acuitas AMR Gene Panel
- K203609 — Intravascular Administration Sets
- K210523 — Implanova
- K211439 — Small Bone Nailing System
- K211450 — Playboy 3 Contour Condom
- K211591 — NAEOTOM Alpha, Scan&GO
- K211593 — Enteral Pump Syringe
- K211935 — ORIO-Ti Intervertebral Body Fusion Cage System
- K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)
- K212227 — Philips MR Patient Care Portal
- K212386 — AngioVac F18 85
- K212405 — EMERGE Anterior Cervical Plate System
- K212757 — Jada System
- K212794 — Accuray Precision Treatment Planning System
- K212805 — SteriCap Mini Needle and Standard Needles
- K200639 — LAP-iX
- K203350 — ENDOtube
- K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
- K210513 — UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
- K210590 — Axis Spine Technologies ALIF
- K210726 — ImmersiveTouch
- K210763 — Inman Digital Clear Aligners
- K211740 — DualX
- K211781 — Disposable Nitrile Gloves
- K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
- K212226 — DR Safety Syringe, Sterile Hypodermic needle for Single use
- K212238 — TheraFace Microcurrent
- K212747 — Da Vinci SP Surgical System
- K201855 — Electrically Powered Wheelchair -Model HP358E
- K202481 — ThermArt (Model IR-EFT)
- K210561 — Advisor Pro Platform
- K210878 — Surgical Face Mask (Model: CM2006, CM2008, A88)
- K210894 — SIDDHARTH-II; IMPACT
- K211700 — EzDent Web
- K211760 — Panther OIS
- K211794 — Disposable surgical mask
- K211964 — SubtlePET
- K212045 — SoftSpot
- K212129 — Persona® Personalized Knee System
- K212320 — Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac
- K203674 — B Dispensing Line
- K211236 — Disposable Vinyl Examination Gloves
- K212026 — Amplatzer Steerable Delivery Sheath
- K212028 — Dark Star Navigation Instrument System
- K212080 — Imaging Plate Scanner, i-Scan
- K212643 — POWERSEAL Curved Jaw Sealer and Divider, Double Action
- K212738 — Amplatzer Talisman Delivery Sheath
- K212750 — Ultrasonic Surgical Aspirator System, Model: XD880B
- K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
- K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
- K203731 — DT100 Digital Thermometer
- K210908 — Surgical Mask
- K212328 — DiscCath Needle Set
- K202618 — IV Administration Sets
- K210857 — Personal Lubricant
- K211505 — Encore Hip Stem
- K211973 — DRI Cocaine Metabolite Assay
- K212099 — Red Wave Hair Removal
- K212108 — Dynamic TiBase
- K212125 — Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
- K212557 — Virtual C DRF-NEO Digital Imaging System
- K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
- K212725 — ViperCross Support Catheters
- K212777 — Collaboration Live
- K202092 — ABC Dental Implant System
- K203446 — TorrentX Wound Wash
- K203662 — Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
- K210152 — Automatic Digital Blood Pressure Monitor
- K210232 — Sterile Hypodermic Needles for Single Use
- K210294 — One Touch Spiral Condom
- K210707 — OnGuard2 Chemfort Closed Administration (CADM)
- K211667 — Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
- K211747 — Reusable NIBP Cuff
- K211827 — Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
- K211974 — LED PHOTIC System
- K211996 — Nexta PEEK Hammertoe Correction System
- K212002 — Synthetic Vinyl Examination Gloves
- K212321 — JiveX (Model Number / Release: 5.3)
- K212342 — ZIIP+ Device
- K212411 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
- K212708 — Halo One Thin-Walled Guiding Sheath
- K212728 — Standard Bougie, 38 Fr. and Hand Pump
- K212792 — Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
- K200423 — Electric Wheelchair (XW-LY001)
- K210045 — ACTIVA PRESTO PACK
- K210263 — Mpres Neck Preserving Stem
- K210772 — 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
- K211097 — Banyan USA Surgical Mask Level 3
- K211805 — IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
- K212160 — SimpleSENSE Platform
- K212353 — DB-EZ Bone Void Filler
- K212660 — Smylio Invisible Clear Aligners
- K212667 — Single Use Guide Sheath Kit-401, K-402
- K212727 — FilmArray Pneumonia Panel
Data sourced from openFDA. This site is unofficial and independent of the FDA.