FDA 510(k) clearances — page 333
clearances on record, most recent first.
Clearances — page 333
33,201–33,300 of 175,770- K152528 — Attachable Cath Lab Hemostasis Valve
- K152566 — PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
- K152632 — XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
- K152840 — Lantern Delivery Microcatheter
- K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
- K153143 — Capiox Advance Hardshell Reservoir
- K150640 — RX-FIX Mini Rail External Fixator
- K151295 — Biodenta Customized Abutment - Titanium
- K151658 — Gmate Origin Blood Glucose Monitoring System
- K151878 — Video Colposcope
- K152060 — 3M Attest Rapid Readout Biological Indicator 1295
- K152121 — NuVent EM Sinus Dilation System
- K152173 — Glidesheath
- K152211 — PCT System
- K152417 — Adler MicroMed Laser Surgery Fibers
- K152943 — NuVasive Foundation-LL System
- K153148 — CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
- K152518 — Vonflex S Putty
- K150238 — SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
- K150603 — Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
- K151186 — Stay Fresh Hydrocolloid dressing
- K151673 — Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
- K151679 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K142211 — OT EQUATOR
- K150077 — SonicLift
- K150528 — Cortisol Saliva Luminescence Immunoassay
- K150561 — NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
- K150942 — Contour Next USB Blood Glucose Monitoring System
- K151469 — CORVUS Radiation Therapy Planning System
- K151656 — HEARTWAY Power Mobility Scooter
- K152000 — SMV Scientific Bone Plate and Screw System
- K152490 — DERMABOND PRINEO Skin Closure System
- K152494 — Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
- K152573 — 4Sight
- K152761 — Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
- K152779 — Avex CX2
- K152785 — XIDF-AWS801, Angio Workstation, V6.20
- K152822 — VidiStar HeartView
- K152939 — Picasso Plus, Picasso Lite Plus
- K153096 — LARIAT RS Suture Delivery Device
- K153142 — Carestream DRX-1 System with DRX Plus 4343 Detectors
- K153180 — Tyber Medical MST Trauma Screw
- K153182 — SELF- COMPRESSIVE SCREW
- K133178 — LUXATOR LX HANDPIECE
- K142955 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
- K150550 — SilverCoat Silicone Foley Catheter
- K150618 — PENTAX Medical EPK-i7010 Video Processor with GI Family
- K151125 — AVAflex Vertebral Balloon System
- K151191 — OES ELITE Telescopes, Protective Tube
- K151265 — SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
- K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- K152046 — Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
- K152057 — OsteoCool V-3 RF Ablation System
- K152225 — Edwards eSheath Introducer Set
- K152242 — G3¿ Active Plate® Large Fragment System
- K152838 — HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
- K152841 — Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
- K152846 — HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
- K153150 — AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
- K143669 — MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
- K143704 — Advanced Air System
- K151739 — Revision Femoral Stem
- K151764 — YAMAHACHI PMMA DISKS
- K152055 — Ceramax Skin Barrier Cream
- K152067 — Ponto bone anchored hearing system
- K152272 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K152349 — Star+ VPS Scannable Impression Material
- K152495 — Wondfo Propoxyphene Urine Test
- K152762 — Fogarty Occlusion Catheter
- K153102 — QuadraSphere Microspheres
- K153115 — Arthrex Univers Apex, Size 5 Stem
- K151034 — PainKARE
- DEN150001 — RELIZORB
- K142617 — ArcCHECK
- K150514 — Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
- K150525 — SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
- K150571 — 3i T3 Short Implants
- K150698 — Gemini Sterilization Wrap
- K150825 — Collagen Dural Regeneration Matrix
- K151414 — IQQA Guide
- K151692 — BioArchitects Patient Specific Cranial/Craniofacial Plate
- K151738 — Single Use Aspiration Needle NA-U200H
- K151770 — Libra Pedicle Screw System
- K151773 — CONCORDE Bullet Lumbar Interbody System
- K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
- K152110 — e-1 etchants
- K152282 — Cam Lock Plating System
- K152434 — XprESS Multi-Sinus Dilation System
- K152435 — PassAssist LED Light Fiber
- K152641 — Pi Drive Plus Motor, Extender
- K152711 — Parcus GFS Naked
- K152713 — 8MP Color LCD Monitor, RadiForce RX850, RX850-AR
- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K153086 — RX ACCUNET Embolic Protection System
- K153219 — ProFlu+ Assay
- K143310 — MoisturemeterD
- K150094 — Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
- K150299 — Gmate SMART Blood Glucose Monitoring System
- K150455 — RT2 Trabeculite Titanium Cervical Cage System
- K150637 — Aerin Medical Wand Model FG011
Data sourced from openFDA. This site is unofficial and independent of the FDA.