FDA 510(k) clearances — page 228
clearances on record, most recent first.
Clearances — page 228
22,701–22,800 of 176,542- K191063 — 1-Step Culture Medium
- K191119 — EkoSonic Endovascular Device
- K191130 — Customized Contour Implant
- K191177 — LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
- K191180 — Electronic Blood Pressure Monitor
- K191412 — VariAx 2 System, VariAx 2 Mini Fragment System
- K191809 — MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
- K191981 — REMEDY Acetabular Cup
- K191990 — OSW Aligner System
- K192047 — Rampart One Lumbar Interbody Fusion System
- K181888 — Osstell Beacon
- K190126 — Bendit2.7 Steerable Microcatheter
- K190402 — Triathlon Total Knee System-Additional Components
- K190792 — BB-613WP
- K191242 — HEALIX ADVANCE SP BIOCOMPOSITE Anchor
- K191393 — INFINITY Total Ankle System, INBONE Total Ankle System
- K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
- K192021 — NCB Polyaxial Locking Plate System
- K183390 — QNext and DG-PT
- K190026 — Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
- K190044 — VSP Orthopedics System
- K190081 — RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K191413 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
- K191623 — ScanX Touch/ScanX Duo Touch
- K191948 — GlideScope BFlex 5.8 Single-Use Bronchoscope
- K182086 — ARCO FP
- K191561 — Exactech Equinoxe Humeral Augmented Trays
- K191936 — iNSitu Total Hip System
- K183356 — Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
- K190207 — Blood Pressure Monitor
- K191339 — Zavation eZspand Interbody System
- K191342 — CrossRoads Screw System
- K191985 — Optilite IgA Kit
- K183108 — Combined Aerobika OPEP and VersaPAP device
- K183536 — Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
- K190722 — TriMAX Implant System
- K190735 — EQ Balance
- K190853 — Vyntus BODY
- K190988 — GIM-STIM OTC TENS/EMS System
- K191079 — Piezon Built-in Kit, Piezon Built-in Kit LED
- K191349 — 980nm Diode Laser Therapy Device
- K191504 — PowerDR
- K191609 — Tria Soft Ureteral Stent
- K191626 — Stat Profile Prime ES Comp Plus Analyzer System
- K191636 — APTUS Foot System
- K191645 — SKR 4000
- K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- K191924 — SAFECARE® THC Urine Strip Test
- K191933 — COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
- K192018 — Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
- K183208 — Suprasorb A + Ag R
- K183230 — OneDraw A1C Test System
- K183282 — Biovitals Analytics Engine
- K190264 — Viola
- K190328 — HCT Empty EVA Container Pack
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K190925 — HeartFlow FFRct Analysis
- K190991 — Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
- K191200 — TULSA-PRO System
- K191621 — ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System
- K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit
- K191922 — ACUSON P200 Diagnostic Ultrasound System
- K182618 — SleepImage System
- K190063 — Servator C SALF Solution
- K190261 — BOSS Toe Fixation System
- K190689 — SignalMark Breast Marker
- K190849 — IS-III active System_S-narrow Type
- K190852 — Zurich Pressure Guidewire System Model 100
- K191241 — AutoStrut
- K191553 — NuVaisve® Reline® Cervical System
- K190428 — Elecsys Anti-HAV II
- K190970 — PROSTEP TBI (Tailors Bunion Implant) System
- K191024 — xPORT Lens Fragmentation System
- K191376 — Modular Power Standing System
- K191582 — Cartesion Prime
- K191731 — Instylla Microcatheter
- K183182 — Critical Care Suite
- K183316 — Dr J Spinal and Epidural Needles
- K190025 — EVOL® -SI Joint Fusion System
- K190491 — Blue Sky Bio Zygomatic Implant System
- K190870 — Cervical Spinal Truss System-Stand Alone (CSTS-SA)
- K191009 — Arsenal Plating System
- K191311 — ATEC Lateral Interbody System
- K191494 — Facilis Spinal System
- K182881 — Bone Screw, Bone Tack
- K183158 — NxStage Cartridge Express with Speedswap
- K183203 — ELAN 4 Tools
- K183647 — SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories)
- K190371 — Morpheus-C
- K191114 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
- K191233 — ARIETTA 750
- K191560 — Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
- K191792 — Versana Balance
- K191798 — Versana Active
- K191884 — DR 100s
- K181760 — Transit-Pellets
- K183312 — Conformity Stem
- K190385 — CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
- K190562 — iTotal Identity Cruciate Retaining Knee Replacement System
- K190674 — REFRESH RELIEVA For CONTACTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.