FDA 510(k) clearances — page 162
clearances on record, most recent first.
Clearances — page 162
16,101–16,200 of 175,699- K211354 — Disposable Synthetic Vinyl Nitrile Examination Glove
- K200193 — Kisses Plus Implant System
- K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity
- K203305 — Tiger Reusable Sharps Container
- K210320 — ClearCorrect System
- K210541 — ulrichINJECT CT motion
- K210725 — Nitrile Patient Examination Glove
- K211202 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
- K211435 — PAO Cortical Screw
- K211725 — Senographe Pristina
- K211764 — Vereos PET/CT
- K211783 — TriMed Threaded Intramedullary Nail System
- K211784 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K212100 — Kosmos
- K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
- K201089 — ARK Lacosamide Assay
- K202621 — NeuroSENSE Monitoring System, Model NS-901
- K202969 — Biomet Microfixation OmniMax MMF System
- K203006 — R2 Dermabrasion Tip (for Dermal Cooling System)
- K203362 — TRACOE vario
- K203727 — Harmony Latex Dam, Harmony Non-Latex Dam
- K210680 — AcQMap High Resolution Imaging and Mapping System
- K211075 — Disposable Medical Nitrile Examination Gloves (Non-Sterile)
- K211388 — Lateral Spine Truss System (LSTS) Interbody Fusion Device
- K211434 — Nitrile Patient Examination Gloves
- K211608 — Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
- K211657 — EMPHASYS Femoral Stems
- K211893 — SelectFlex Neurovascular Access System Family
- K203246 — Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
- K203464 — DESS Dental Smart Solutions
- K210643 — Disposable Surgical Face Mask
- K210913 — V12 PRO
- K211049 — Tigon Medical Button System
- K211068 — PrevisEA Device
- K211502 — Alpha Vent PEEK Suture Anchor
- K211553 — Tecomet Global Unite Short Stem Instrumentation
- K211714 — Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
- K211838 — Ultrasonic Bipolar Generator USG-410 with accessories
- K212056 — Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
- K201246 — PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
- K210651 — Resection Electrodes with HF cable
- K210724 — ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
- K211026 — Minitube Dentasleeve Protective Barrier Sleeves
- K211290 — Cannulated Fasteners and Nuts
- K211758 — Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
- K211806 — Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter
- K211897 — Surgical Face Mask
- K212144 — Remex KA6
- K200986 — OPTI® B-Lac Cassette
- K203174 — Disposable Medical Mask
- K203538 — SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
- K203542 — Neodent Implant System - Mini Abutment 60°
- K210339 — Bullfrog Micro-Infusion Device
- K210521 — DEXA-C Cervical Interbody System
- K211431 — breastscape v1.0
- K212106 — Relivion
- K212175 — DynaCAD
- K211182 — H2H Powder Free Examination Blue Glove
- K200770 — Mini PCNL-System
- K201761 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial
- K202780 — Sectum
- K203224 — Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
- K203408 — Summit Patella Plating System
- K203700 — Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
- K203796 — Firefly Needleless Connector
- K210154 — Labat series Diagnostic Ultrasound System
- K210248 — Lab Bag with Fabric Pouch
- K210264 — BD PowerPiCC Catheter
- K210274 — Fingertip Pulse Oximeter
- K210691 — Disposable Nitrile Medical Examination Glove
- K210768 — Wrist Blood Pressure Monitor, Blood Pressure Monitor
- K210870 — MEO Med Disposable Medical Face Mask
- K210938 — PowerDot PD-01MT2 Muscle Stimulator
- K211222 — qER-Quant
- K211264 — Disposable Nitrile Examination Gloves
- K211338 — EMBOTRAP III Revascularization Device
- K211379 — syngo.via RT Image Suite
- K211380 — Elexir
- K211402 — Powersculp laser lipolysis system
- K211492 — Pounce Thrombectomy System
- K211710 — Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
- K211761 — UltraLase Flexible CO2 Laser Waveguide
- K211790 — DX-D Imaging Package with XD Detectors
- K212035 — FibroScan 230
- K202825 — BTI Extra-Short Dental Implant System UnicCa
- K203753 — Straumann Surgical Cassettes
- K210115 — FiteBac CC OrthoSeal
- K210574 — NuVasive Pulse System
- K210770 — Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
- K210862 — Hemafuse System
- K210953 — SMART Taylor Spatial Frame
- K211131 — Disposable Nitrile Medical Examination Glove
- K211229 — Vinyl compound examination gloves
- K211314 — OCS Lung Solution
- K211317 — CRUXVIEW
- K211341 — Blue Nitrile Exam Gloves
- K211663 — Zap-X Radiosurgical System
- K211664 — GMK Sphere Revision
- K201657 — Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
Data sourced from openFDA. This site is unofficial and independent of the FDA.