FDA 510(k) clearances — page 303
clearances on record, most recent first.
Clearances — page 303
30,201–30,300 of 176,542- K163563 — VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL)
- K170030 — NOVATECH TALCAIR
- K170116 — Thermi Injectable RF Electrodes
- K163152 — PROLENE Soft Polypropylene Mesh
- K160815 — Interstitial Needles
- K162509 — Infrared Non-contact Thermometer, Model ACT8100
- K162589 — Adscope 658 Electronic Stethoscope
- K162733 — iFuse Implant System® - iFuse-3D implant
- K162793 — RHYTHMIA HDx Mapping System
- K162935 — Rapid2 Therapy System
- K163376 — Mikro-Cath Pressure Catheter
- K163474 — CAVUX CervicalCage-L SA System
- K163495 — AdvanCE capsule endoscope delivery device
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K170084 — InterLock Trocar
- K170336 — BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
- K170508 — EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
- K170512 — Altus Spine Titanium Interbody Fusion System
- K161547 — Transem and EchoGen Embryo Transfer Catheters
- K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
- K162412 — Hoggan Scientific® microFET2
- K162506 — PhotoFix Decellularized Bovine Pericardium
- K163118 — FLEX Microwave Ablation System and Accessories
- K163224 — JAZZ SOLO Sensor
- K163247 — 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
- K163286 — ARTIS pheno
- K163604 — SeaSpine® Daytona® Small Stature Spinal System
- K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- K170124 — Level One Hand Plating System
- K170126 — NuVasive® Reline® 4.5-5.0 System
- K170267 — BGM009 Plus Blood Glucose Monitoring System
- K170391 — ANSiStim-PP
- K170528 — Sterispine PS
- K160641 — Solitaire Platinum Revascularization Device, 6x40 mm
- K161681 — Nipro SafeTouch IV Catheter
- K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
- K161898 — Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
- K162394 — CRC-77tHR
- K162804 — Q2 Low Pressure Power Injection Extension Set
- K162890 — BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
- K163054 — DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
- K163307 — Expro Elite Snare, Sympro Elite Snare
- K163409 — Rampart(TM) T Lumbar Interbody Fusion Device
- K163450 — VIVA combo RF System
- K163489 — OrthoSolutions 'System26' Bone Screws
- K163654 — VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
- K170095 — Vial2Bag Direct Connect
- K170188 — Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
- K160067 — RenovoCath
- K160721 — Vado Steerable Sheath
- K161865 — iSage Rx (iSage Rx Basal Insulin Titration)
- K162311 — Straumann PrefGel
- K162870 — CIMLRE F1 and CIMILRE S3
- K162906 — Flexi-Seal PROTECT Fecal Management System
- K162919 — Male Latex Condoms
- K170346 — PRECICE Intramedullary Limb Lengthening System
- K170403 — CenterCross Ultra LV Catheter
- K162033 — SALVATION External Fixation System
- K162035 — GMK Sphere
- K162325 — Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
- K163188 — Next Science Wound Gel (Rx)
- K163436 — Greiner Vacuette Urine Count and Culture, Mannitol tube
- K170430 — TSolution One Surgical System Model 210
- DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests)
- K160345 — Glass Ionomer Cement
- K161918 — SREE MRI Transport Incubator
- K161991 — Curasite
- K162044 — Dentca Denture Base II
- K162524 — AZUR CX Detachable 18 Peripheral Coil System
- K162529 — DigiX FDX
- K162575 — Z-LINKPC System
- K162580 — Guardian Angel GA1000 Digital Vital Sign Monitoring System
- K162646 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- K162746 — Ontex and other proprietary names
- K162947 — Disposable End-to-end Anastomosis Circular Stapler +3 more
- K163528 — HITACHI Supria Whole-body X-ray CT System Phase 3
- K163552 — iPulse SmoothSkin BARE Hair Removal Device
- K163575 — Inqwire Diagnostic Guide Wire
- K170058 — TheraView TBI
- K170164 — 3D OCT-1 Maestro
- K170167 — True 3D Viewer Software
- K170314 — ACL AcuStar
- K170331 — Cyber Ho
- K170350 — ToeMATE® Hammertoe Correction System
- K153538 — Dextramer CMV Kit
- K153688 — Edi Catheter ENFit
- K161304 — EndoPur Filter
- K161430 — Myoject Luer Lock Needle Electrode
- K161554 — ENDOFLATOR 40, ENDOFLATOR 50
- K161633 — REXLON, REXSIL
- K161737 — RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
- K161892 — Slimming Treatment Device
- K162199 — Cascade IOMAX Intraoperative Monitor
- K162356 — Vesair Cystoscopic Sheath
- K162364 — Intellijoint HIP Generation 2A System
- K162410 — TIPCAM 1S 3D System
- K162811 — MR Conditional CGA 870
- K163379 — KneeAlign 2 System
- K163497 — EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
- K170348 — Signia Four-Bay Smart Charger (to be used with Signia Stapler)
Data sourced from openFDA. This site is unofficial and independent of the FDA.