FDA 510(k) clearances — page 67
clearances on record, most recent first.
Clearances — page 67
6,601–6,700 of 176,479- K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0)
- K240468 — Alkaline Phosphatase
- K240596 — Cerebral Autoregulation Index (CAI) Algorithm
- K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
- K241221 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
- K241272 — Stryker Steri-Shield 8 Surgical Hoods and Togas
- K241481 — xvision Spine System
- K241613 — Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
- K241632 — Electrically powered wheelchair
- K242556 — JLK-CTP
- K242784 — Vy Spine VyLam Laminoplasty System
- K242794 — ONCOZENE Microspheres
- K242839 — Safe Secure Sterilization Pouches and Rolls
- K231997 — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
- K240192 — Single-use Extraction Baskets
- K240385 — VINT
- K241673 — Denture Base Resin (PN-Denture (Red, White))
- K241894 — Artix MT; Artix Thin-Walled Thrombectomy Sheath
- K242097 — DenMat Bulk Fill Composite
- K242536 — TauTona Pneumoperitoneum Assist Device (TPAD)
- K242781 — cvi42 Software Application
- K242795 — Getinge Assured MI Steam Migrating Integrator
- K242812 — NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
- DEN230078 — Versius Surgical System
- K232565 — UriSponge
- K232779 — QUEX ED; QUEX S
- K233265 — Monotime and Optime R
- K234110 — Belun Ring BLR-200 (BLR-200)
- K240143 — JDZygoma dental implants
- K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
- K240472 — PBM Hair Therapy Cap
- K240499 — ARTAIRA Arterial Compression Device (AACD01)
- K240501 — Spark Clear Aligner System
- K240797 — PPH Saliva Collection Kit
- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
- K241153 — Progressive Orthodontics App
- K241163 — SPECTRALIS with Flex Module
- K241569 — syngo Application Software
- K241857 — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
- K241971 — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
- K242035 — Accure Laser System
- K242095 — Access Toxo IgM II
- K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) +1 more
- K242387 — Mobility Scooter (N3473)
- K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF)
- K242779 — Hood (DH-083ST)
- K242833 — Legend® Acetabular Shell
- K230325 — GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
- K233947 — KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System
- K240262 — BTI Interna 3.0 Dental Implant System UnicCa®
- K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
- K240786 — AutoChamber
- K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance
- K240992 — eMVFit (MVF-10M)
- K241092 — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
- K241430 — EchoMeasure
- K241491 — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
- K241735 — ProSeal In Line Pump Set (423850)
- K241951 — Lasya-Trinity
- K242389 — EyeGility Inserter for Preloaded enVista IOLs
- K242400 — Dental porcelain powder
- K242515 — uDR 380i Pro
- K231948 — MEDIYAG
- K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
- K240181 — Clavicle and Scapula System
- K240991 — eMVFit (MVF-10M)
- K241355 — SER Pen Carain MicroSystem (MP1209SP)
- K241477 — aprevo® anterior lumbar interbody fusion device with interfixation
- K241485 — TruAbutment DS; TruBase
- K241837 — Limbus Contour
- K242021 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.
- K242029 — TRAP EASY
- K242691 — OsteoCentric Technologies Cannulated Fasteners and Nuts
- DEN230076 — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) +1 more
- K240167 — Single-use Ureteral Access Sheath
- K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
- K240563 — Power Wheelchair (JJW-6001)
- K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
- K241446 — Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
- K241756 — Nerivio; NerivioInfinity
- K242014 — Jet Flow Bulk
- K242267 — Gemini Medical Cage System
- K242391 — Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
- K242826 — ProLift Wedge Expandable Spacer System
- DEN240029 — Healgen Rapid Check COVID-19/Flu A&B Antigen Test
- K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
- K240843 — GENESIS (MS-P02-GEN)
- K240980 — EPIQ Series Diagnostic Ultrasound System
- K241029 — SpineUs System
- K242084 — EMPHASYS Acetabular Shell with RapiTite HA
- K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
- K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K242357 — Water Container (MAJ-901); Water Container (MAJ-902)
- K242375 — OR3O Dual Mobility System
- K242457 — EARP Interbody System
- K242693 — DEKA Infusion System, DEKA Administration Set
- K242746 — OvertureTi Knee Resurfacing SystemTM
- K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
Data sourced from openFDA. This site is unofficial and independent of the FDA.