FDA 510(k) clearances — page 148
clearances on record, most recent first.
Clearances — page 148
14,701–14,800 of 176,479- K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
- K211837 — Altus Spine Interbody Standalone Fusion System
- K212241 — QUATERA 700
- K213930 — Brainlab Elements Guide XT, Guide 3.0
- K220075 — Spartan Center Wire
- K220149 — General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
- K220152 — TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
- K220810 — Infinity OCT System and PASS OCT Spinal System
- K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
- K220131 — KYPHON VuE Bone Cement
- K220871 — Nautilus
- K213408 — BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
- K212377 — Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
- K212522 — Lilliput APD System
- K212677 — aboNT SYRINGE
- K212773 — ARDO Alyssa
- K213350 — mJOULE System and Accessories
- K213706 — AI-Rad Companion Brain MR
- K220141 — RayStation 11B
- K220459 — Mako Total Knee Application
- K220779 — XD
- K220797 — FootHold System
- K220946 — SURGIVISIO Device
- K212163 — Coala Heart Monitor
- K213959 — MagnetOs Flex Matrix
- K214023 — VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
- K214053 — Amputee Garment for use with Lympha Press Optimal Plus
- K220252 — High Retention Attachment System
- K220510 — Yushan X-Ray Flat Panel Detector with DROC
- K220561 — Disposable Medical Nitrile Examination Gloves
- K220767 — TeleScan
- K203842 — Bendit21 Microcatheter
- K210146 — Cannulated Compression Device System
- K210148 — Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
- K210419 — BIOTEQ Drainage Catheter BT-PDS-series
- K210634 — MCL 31 Dermablate System
- K211090 — ZENEX Implant System
- K212202 — WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
- K212245 — Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
- K212260 — Sensuva Premium Silicone Personal Lubricant
- K213133 — Keffort (MC-100, MC-100A)
- K213181 — CARESCAPE B650, E-musb
- K213336 — Carescape B850, E-musb
- K213363 — CARESCAPE B450, E-musb
- K214051 — Neodent Implant System-Helix NGM Compact Surgical Kit Cases
- K220373 — Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
- K220375 — Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
- K220556 — OpenSensorX Series
- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K212811 — Ti3Z Lumbar Interbody System
- K213234 — CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
- K213296 — Anprolene SteriTest RRBI
- K213398 — EMBOLD Fibered Detachable Coil System
- K213518 — CARESCAPE CO2 Microstream parameter
- K213557 — Finexel
- K213650 — ThermPix Thermovisual Camera
- K214010 — Anteralign Spinal System with Titan nanoLOCK Surface Technology
- K214025 — PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
- K214040 — ClearPoint Array System (version 1.1)
- K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
- K214088 — Disposable Surgical Gown
- K220027 — Audion ET dilation system
- K220103 — LED Therapy Device (Planar LED/Planar LED mini)
- K220405 — Amis K Long
- K212719 — Micro Catheter and Guidewire System
- K212881 — Intense Pulsed Light (IPL) System
- K212962 — TRELLIS SI Joint Fusion System
- K213437 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
- K213675 — MP Reconstruction System
- K214107 — XO CROSS CORONARY Support Catheter
- K220121 — Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black
- K220158 — G-EYE System
- K220209 — Powder Free Nitrile Examination Glove, Non-sterile (Blue)
- K220477 — Cellvizio 100 series system with confocal Miniprobes
- K220737 — World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)
- K212929 — Nitrile Examination Gloves
- K220401 — Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
- K202389 — Oxygen Concentrator
- K210109 — visor2 system
- K212017 — Thermeo System
- K212274 — INT Contour
- K212309 — Non-sterile, Powder-Free Latex Examination Glove
- K212372 — Fitbit Irregular Rhythm Notifications
- K212882 — SCOUT BX Delivery System
- K213015 — DORA Disposable A.V. Fistula Needle Sets
- K213063 — TLX SRAs and TLX Gold Abutments
- K213509 — Latex Examination Gloves, Powder Free
- K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
- K213958 — Bioabsorbable Anchor
- K220144 — Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
- K220192 — Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
- K220490 — ImaCor Zura Handheld ZHH-010
- K220699 — Prestige Coil System
- K220724 — CD Horizon Spinal System and PASS LP Spinal System
- K220809 — Drive Rail System
- K210860 — Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
- K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer
- K212069 — Corin MetaFix Hip Stem
- K212203 — Dong Hai Xiang Surgical Mask
- K212278 — Electrocardiograph
Data sourced from openFDA. This site is unofficial and independent of the FDA.