FDA 510(k) clearances — page 87
clearances on record, most recent first.
Clearances — page 87
8,601–8,700 of 175,620- K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
- K232925 — Gastric Alimetry System
- K232974 — EKGenius Smart System
- K230451 — Aptima® Chlamydia trachomatis Assay
- K231445 — LINK Embrace Shoulder System - Reverse Configuration
- K231652 — D100 KIDS; D101 KIDS
- K231694 — MASADA Modular Spinal Fixation System
- K231738 — NEUWAVE Microwave Ablation System and Accessories
- K232139 — Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
- K232392 — CT Lung Ventilation Analysis Software (CT:V)
- K232521 — ExactechGPS® Total Ankle Application
- K232533 — ROSA Partial Knee System
- K232753 — EXPD 4343D; EXPD 3643D
- K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
- K232945 — Trio-CT® Triple Lumen Catheter w/ Curved Extensions
- K233200 — XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
- K233302 — OSSIOfiber® Compression Staple
- K233443 — Vital Navigation System
- DEN200070 — Simple 2 Test
- K223414 — Curing Light, Model: MaxCure 9
- K230463 — NSite Scoliosis Assessment App
- K231012 — CoolSeal Trinity
- K231818 — METIC- Airway Balloon Catheter
- K231852 — BinkieRT
- K232841 — Axial3D Insight
- K232973 — Arthrex Knee FiberTak® Button Suture Anchor
- K230856 — BrainSpec Core Software
- K230878 — QScout Lab; QScout RLD
- K231097 — Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
- K231521 — Broncho Videoscope System
- K231554 — UniPearls® Embolic Microspheres
- K231783 — VitroPRO
- K232050 — saremco print BRIDGETEC
- K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2)
- K232461 — Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis
- K232494 — MAGNETOM Avanto fit; MAGNETOM Skyra fit
- K232656 — BLU TOTALE (Model: ENEOB852)
- K232845 — IPL Cooling Hair Removal Device
- K233434 — Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)
- K233468 — Iconix Anchor
- K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
- K230849 — ELLAVI UBT
- K231118 — Cystoscope System
- K231937 — Foundation Dermal Regeneration Scaffold (DRS) Solo
- K232083 — BriefCase-Quantification
- K232240 — Microwave Ablation System (BD-GT)
- K232241 — Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
- K232257 — Clarius Bladder AI
- K232488 — Accu-Chek Safe-T-Pro Plus Lancing Device
- K232509 — Accu-Chek Safe-T-Pro Uno Lancing Device
- K231564 — Skin and Wound Cleanser
- K222780 — LILY Extension Tube and Needleless Connector
- K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K223754 — BraveCX
- K230828 — Flowflex COVID-19 Antigen Home Test
- K230969 — Oxygen Concentrator
- K231150 — Cardio P1
- K231277 — TissueStat
- K231366 — Neuronaute Plus
- K231508 — Power Wheelchair, W5521
- K231617 — MAGNETOM Free.Max; MAGNETOM Free.Star
- K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)
- K231752 — ARK Hydrocodone Assay
- K231804 — PRIME-XV FreezIS DMSO-Free MD
- K231911 — Glenoid Reconstruction System Full Wedge Baseplate
- K231920 — Longeviti ClearFit OTS Cranial Implant
- K232442 — Disposable Endoscope Injection Needles
- K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit
- K233366 — SYMPHONY OCT System
- K233408 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K233596 — VarseoSmile TriniQ
- DEN220091 — Dream Sock
- K223739 — VS Tabletop Tonometer
- K230400 — Cure Catheter Closed System; Cure Dextra Closed System
- K230534 — BriefCase-Quantification
- K231765 — Contour ProtégéAI
- K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
- K231798 — da Vinci SP Surgical System
- K232152 — NerivioInfinity
- K232886 — INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
- K231155 — Biodegradable Medical surgical mask
- K231966 — LOGIQ E10
- K231989 — LOGIQ E10s, LOGIQ Fortis
- K232292 — Peridot-EX Expandable Intervertebral Body Fusion System
- K232476 — Disposable Sphincterotome
- K232866 — Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
- K233420 — Axium Detachable Coil; Axium Prime Detachable Coil
- DEN220090 — EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)
- K231316 — Aptima Trichomonas vaginalis Assay
- K231470 — Lunit INSIGHT DBT
- K231519 — Revital Cady
- K231865 — Mouth Guard (ATG0603R)
- K232857 — KARL STORZ ICG Imaging System
- K230078 — TRAX® CR Total Knee System
- K230100 — SCIZER (SC1-M410)
- K230343 — ProSeal Closed System Administration Set
- K230475 — Medical Video Endoscope System
- K230481 — Evenflo Premium Double Electric Breast Pump (Model 4018)
- K231182 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
- K231254 — GripTract-GI Endoscopic Tissue Manipulator
Data sourced from openFDA. This site is unofficial and independent of the FDA.