FDA 510(k) clearances — page 356
clearances on record, most recent first.
Clearances — page 356
35,501–35,600 of 176,542- K151132 — PROBEAT-V
- K142692 — Occlusion Balloon Catheter
- K150526 — Optilite IgG4 Kit
- K141907 — STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
- K142417 — SP-1PSpecular Microscope
- K142478 — opti-Toe
- K142768 — Instru-Safe Instrument Protection System
- K143028 — Azure Anterior Cervical Plate System
- K143263 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
- K143321 — ITST Intertrochanteric/Subtrochanteric Fixation System
- K143430 — SmartTENS
- K143496 — Piccolo Composite Plate System
- K150271 — Prime Adaptive Ultrasonic Scalpel System
- K150544 — Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
- K150679 — EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
- K150778 — Various Brands of Ultraviolet Lamps
- K150885 — MAGEC 2 Spinal Bracing and Distraction System
- K150887 — Para-Fix C&S Medium
- K150890 — Exactech Optetrak Logic CC
- K151163 — Signia Loading Unit, Tri-Staple 2.0 Cartridge
- K141320 — LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
- K141874 — URISCAN OPTIMA
- K142355 — Vaginal Tactile Imager
- K142494 — ViMove
- K142586 — Captiva Spine FuselOX Cervical IBF System
- K142954 — PTA 14 Balloon Dilatation Catheter OTW
- K143256 — SMR Modular Glenoid
- K143285 — Mandible External Fixator - MR Conditional
- K150129 — AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
- K150130 — Ascendant TM Cervical Spacer System
- K150513 — Imed Technology Intravascular Administration Set, Imed Technology Extension Set
- K150802 — Heavy Double Flexible Tipped Wire Guide
- K150824 — TD-Wand
- K143198 — Synapse Transcutaneous Electrical Stimulation Device
- K150117 — Medtronic Patient Asistant
- K150137 — SpiroThor
- K150282 — Shaser Skin Beauty Intense Pulsed Light System Family for Acne
- K150511 — Coating Material
- K150627 — Rapid Aid Instant Disposable Infant Heel Warmer
- K150707 — IntelePACS
- K150927 — Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
- K151110 — Intersept Filtered Cardiotomy Reservoir
- K151134 — 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
- K140386 — LUMINA 24
- K141902 — LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER
- K142549 — Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
- K142870 — Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
- K142971 — AMT Bridle - Nasal Tube Retention System
- K143118 — Human Microalbumin kit for use on SPAPLUS
- K143304 — Sickbay Clinical Platform
- K150091 — Versatex Monofilament Mesh
- K150269 — Ballancer 505 System, Model 1201-AC
- K150420 — Centricity Universal Viewer
- K150454 — Acryfree Denture Base Material and Biosens Denture Base Material
- K151145 — 2.4mm X 127 cm Phoenix Atherectomy Deflecting System
- K151173 — Biomet Microfixation RibFix Blu Thoracic Fixation System
- K140068 — CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
- K140654 — Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
- K142385 — Whisper Pump System
- K142458 — Penumbra System ACE
- K142648 — SPINEDESIGN Spine Surgery Planning (Software Application)
- K142666 — Scrambler Therapy MC-5 A Device
- K142806 — DualCap
- K143683 — APEX-DL Spine System
- K143740 — Battalion Universal Spacer System
- K150069 — Fine Structure Analysis(fineSA)
- K150139 — Rachel's Remedy
- K150463 — CalcaNail Orthopedic Nail
- K150471 — CalcaNail Orthopedic Arthrodesis Nail
- K150563 — Marrow Cellution Bone Marrow Aspiration Needle
- K150600 — Response 5.5/6.0 Spine System
- K150628 — VentriPoint Medical System
- K150779 — LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
- K150801 — Stryker Maestro Air Motors
- K150941 — Somnowell Mandibular Advancement Appliance (MAA)
- K151076 — MicroTaper Needle Introducer Set
- K151102 — Bausch + Lomb Injector System
- K151222 — Cautery Tip Cleaner
- K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
- K143060 — Intelli-Ox
- K143436 — InvisionECG System
- K143603 — Darlinghurst Vented, Darlinghurst NV-AAV
- K143660 — Milagro / Milagro Advance Interference Screw
- K150151 — SmartGownTM surgical gown
- K150297 — PlasmaBlade UPPP and Suction Coagulator
- K150446 — Erchonia Zerona 6 headed scanner EZ6
- K150467 — Retina Workplace
- K150733 — Vital-Port Vascular Access System Power Injectable Port
- K140491 — TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS
- K141748 — RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
- K141900 — SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
- K142422 — cobas Cdiff Test
- K142719 — E-App
- K142724 — BIOFOAM Bone Wedge
- K143502 — Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
- K143511 — K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
- K143562 — Reprocessed Cordless Ultrasonic Dissection Device
- K150090 — Zimmer Persona Personalized Knee System
- K150453 — TULA Iontophoresis System with Earset
- K150461 — StatStrip Xpress Glucose Hospital Meter System
Data sourced from openFDA. This site is unofficial and independent of the FDA.