FDA 510(k) clearances — page 145
clearances on record, most recent first.
Clearances — page 145
14,401–14,500 of 176,479- K212752 — Med-link Pulse Oximeter
- K212979 — CalcShift Displacement Calcaneal Osteotomy System
- K213540 — Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
- K220381 — Diode Laser Therapy Systems
- K220522 — 7D Surgical System - Percutaneous Application (7D Flash Frame)
- K220656 — iovera System
- K220832 — syngo Dynamics (Version VA40E)
- K220838 — Artisan Bone Plug, Universal Cement Restrictor
- K202525 — Alinity i STAT High Sensitivity Troponin-I
- K210596 — ARCHITECT Toxo IgG
- K210983 — BD Epilor Syringe
- K211534 — RevoLix HTL
- K211869 — OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
- K212565 — CoverScan v1
- K213174 — Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
- K213800 — Artiglass NRFitTM Tip L.O.R. Glass Syringes
- K220285 — PINE Pedicle Screw System
- K220370 — Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
- K220392 — PAPAYA 3D & PAPAYA 3D Plus
- K220423 — PAPAYA & PAPAYA Plus
- K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
- K220792 — SMR Reverse Liner
- K220824 — Medical Surgical Mask (Planar type)
- K220849 — Accu-Chek Safe-T-Pro Plus Lancing Device
- K221134 — Procedure Mask with Ear Loops and Surgical Mask with Ties
- K221135 — X-Twist PEEK Suture Anchor
- K221232 — Univers Revers Humeral Cup Implant
- DEN210046 — Quell-FM
- K212408 — Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
- K212416 — WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
- K213840 — MolecuLight I:X
- K214120 — GSS610N21 Series Steam Sterilizer
- K220211 — Nitrile Powder Free Examination Gloves
- K220218 — Siren SGT
- K220333 — Medline Orbis LVL 3 Surgical Gown
- K220463 — Osteotomy Truss System (OTS)
- K220467 — The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
- K220468 — BENCOX Mirabo Cup System
- K220917 — gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
- DEN210044 — CERAMENT G
- K210548 — Medline Integrated Arterial Catheter
- K211396 — Neoss Individual Prosthetics
- K212527 — Cervical Spine Truss System Plating Solution (CSTS-PS)
- K212761 — Biocore9 Acetabular Cup System
- K212782 — SternaLock Sternal Closure System
- K213787 — Monaco RTP System
- K220168 — Skin Care Beauty Mask (Model: MJ-06)
- K220194 — Procedure mask/Surgical mask/Face mask
- K220372 — Heel Stick Safety Lancet (HHZ-II, HHZ-III)
- K220499 — Rapid PE Triage and Notification (PETN)
- K220516 — CATALYS Precision Laser system
- K220807 — Imperative Care Radial 088 Access System
- K220919 — MULTIX Impact E
- K221219 — syngo.CT CaScoring
- K221240 — BriefCase
- K210516 — Clicky Cross
- K211665 — SONON Ultrasound Imaging System, Model: SONON300C
- K212376 — Caas Qardia
- K213583 — Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
- K213832 — AAMI3 Isolation Gown
- K220404 — STERRAD NX with ALLClear Technology
- K220669 — IPL HAIR REMOVAL HANDSET, Model: IPL-666
- K220491 — Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
- K220626 — Introcan Safety IV Catheter
- K210575 — HDF Assist Mudule, HDF Infusion Set and Substitution Filter
- K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
- K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
- K212875 — Spectral CT on Rails
- K213119 — Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
- K213137 — INTDose
- K213203 — Provena(TM) Midline Catheter
- K213535 — Sterile Safety Hypodermic Needles for Single Use
- K213785 — SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
- K220115 — ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
- K220186 — Zone Specific AIM
- K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K220429 — Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
- K220589 — MAGNETOM Skyra Fit
- K220749 — Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
- K220757 — Argo Knotless SP Anchor
- K220760 — Pre-Formed Penile Silicone Block
- K221099 — Arthrex Self-Punching PushLock Suture Anchor
- K221106 — Quantib Prostate
- K221115 — Flow-Nail
- K221116 — XACT ACE Robotic System
- K221144 — PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
- K221174 — Telepack +
- K210937 — Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
- K212620 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
- K213025 — Laser hair growth helmet
- K213491 — Universal Pilot Guidance Instrument System
- K213811 — Sterile Hypodermic Syringes for Single Use
- K220105 — Saige-Dx
- K220118 — Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
- K220397 — ANSiStim-PP
- K220430 — Capsulo
- K220442 — Synguard Nitrile Exam Glove
- K220723 — Hand Trauma Screw System
- K220738 — Motive Knee Wrap
- K220740 — Power Wheelchair, W5907 (Q50 R Carbon)
Data sourced from openFDA. This site is unofficial and independent of the FDA.