FDA 510(k) clearances — page 151
clearances on record, most recent first.
Clearances — page 151
15,001–15,100 of 176,479- K203738 — Qitexio
- K203744 — Arterys MICA
- K211324 — 2.4mm Distal Radius System
- K211420 — Stasis Gel
- K212330 — Yadu Medical Face Mask (Level 1)
- K212393 — OPN NC PTCA Dilatation Catheter
- K213790 — Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
- K213894 — DWFritz ASM2000
- K213907 — CareGUARD Sterilization Wrap
- K214043 — BriefCase
- K220049 — Optimotion Implants Porous Metal-Backed Patella
- K213806 — Disposable Medical Face Mask
- K201229 — Intai Anatomic Locking Plate and Screw System
- K201351 — Maxima Surgical Gown
- K202075 — Dental Electric Motor
- K211880 — Minuteman G5 MIS Fusion Plate
- K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus
- K212040 — RI.HIP MODELER
- K212628 — DESS Dental Smart Solutions
- K212920 — Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
- K213005 — Apollo Ankle Fracture Plating System
- K213354 — Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart
- K213534 — PHantom Trilogy
- K213615 — Shoulder Innovations Total Shoulder System
- K213658 — DEKA SMARTPERIO
- K213687 — 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
- K213712 — Pectus Support Bar System
- K213725 — CardIQ Suite
- K213827 — TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
- K213836 — Intracept Intraosseous Nerve Ablation System
- K213869 — EmbryoSlide+ ic8 dish
- K213957 — Demetra Dermatoscope BDEM-01
- K220315 — MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
- K220395 — EndoGator Endoscopy Irrigation Tubing
- K220422 — Dental sensors NanoPix1, NanoPix2
- K220425 — MAGNETOM Vida, MAGNETOM Sola
- K210341 — One Step Pregnancy Test
- K210367 — D-Laser Blue, D-Laser 16
- K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
- K212148 — Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
- K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
- K212755 — SIGNUS SACRONAIL® Transsacral Stabilization System
- K212965 — Smile-100 System
- K213038 — Infrared Forehead Thermometer, model: HS-9802D
- K213373 — Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K213486 — GLP systems Track
- K213566 — ClearRead Xray Pneumothorax
- K213751 — NextAR TKA Platform My Knee PPS
- K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
- K214071 — Hexa-Temp
- K220133 — Sterilization Wraps
- K220361 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- K211155 — Auto CPAP System
- K211780 — ZEN-2090 Turbo
- K212499 — BD Insulin Syringe (0.3mL)
- K213441 — PathLoc Lumbar Interbody Fusion Cage System
- K213849 — SafeOp 2: Neural Informatix System
- K213851 — Disposable Medical Nitrile gloves
- K220069 — 4K UHD LCD Monitor OEV321UH
- K220096 — Genesys Spine 3DP Lumbar Interbody System
- K220340 — Amplatzer Steerable Delivery Sheath
- K220376 — Acetabular Dome Hole Plug
- K203637 — SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
- K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)
- K211140 — Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2
- K212049 — Oclet TDS 1000
- K213434 — Elation Pulmonary Balloon Dilation Catheter
- K213558 — IPL Hair Removal Device
- K213741 — TENS & EMS DEVICE (Model: FM-B2403A)
- K214087 — Medical Face Mask
- K220374 — EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
- K211639 — BTL-785W
- K220450 — syngo.CT Applications
- K220506 — SkinPen Precision System
- K202675 — InRoad® Dental Synthetic Bone Graft
- K210216 — Disposable Automatically Retractable Insulin Safety Syringe
- K210330 — Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
- K210365 — Second Opinion
- K211808 — Medcare Powder-Free Blue Nitrile Patient Examination Gloves
- K211843 — PolyLock Plating System
- K211900 — Patient Information Center iX
- K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
- K212281 — Surgical Trays
- K212356 — Exactech® Equinoxe® Laser Cage Glenoid
- K212723 — BTL-995-rTMS
- K212940 — Skanmobile, Skanmobile-Dr
- K213358 — Surgical Mask
- K213703 — Surgical Gown
- K213994 — Flexible Block
- K220051 — TE Air Diagnostic Ultrasound System
- K220327 — geko W-3
- K211658 — OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
- K211787 — Hemoclip
- K211811 — Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
- K211850 — Air Compression Leg Massager (model: FE-7204B)
- K212149 — MyndMove 2.0
- K212676 — Osteon Precision Milled Suprastructure
- K212720 — nordicDSC
- K213285 — easy Claire
- K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Data sourced from openFDA. This site is unofficial and independent of the FDA.