FDA 510(k) clearances — page 339
clearances on record, most recent first.
Clearances — page 339
33,801–33,900 of 176,542- K152692 — Powder Free Vinyl Patient Examination Gloves (Green)
- K152714 — Quanta Forte
- K152755 — FastFrame External Fixation System-Ankle Spanning
- K152774 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
- K152782 — SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
- K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- K153085 — Q Series Diagnostic Ultrasound System
- K153092 — Ally Uterine Positioning System
- K153210 — Defibrillator Analyzer Variable Load
- K153378 — Monster BITE Screw System
- K153401 — GR40CW
- K153408 — HM70A Diagnostic Ultrasound System
- K153437 — Apex Revision Knee System
- DEN150005 — Newa Skin Therapy System
- K150682 — CUSA Excel+
- K150748 — Flexipet Denuding Pipette, Flexipet Manipulation Pipette
- K150828 — O-RING Condom
- K150898 — LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
- K150930 — Deployable Oxygen Generation System-Smaill (DOGS-S)
- K150931 — MReye Embolization Coils
- K150964 — MReye Flipper Detachable Embolization Coil and Delivery System
- K151126 — Foresight Intracardiac Echocardiography (ICE) System
- K151359 — ROSA Brain
- K151413 — Always/Tampax bladder supports
- K151498 — Breathing circuit bacterial/viral filter
- K151916 — TRI Dental Implant System
- K152150 — V8 Balloon Aortic Valvuloplasty Catheter
- K152384 — Digital Electrocardiograph
- K152387 — Fluent Inflation Device
- K152389 — Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
- K152515 — TOMCAT Cervical Spinal System
- K152532 — AERO -C Cervical Cage System
- K153306 — Imbibe Needle
- K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
- K153417 — ST AIA-PACK PROG III Calibrator Set
- K153499 — EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension
- K142785 — PRODIGY iConnect Blood Glucose Monitoring System
- K150792 — Next Science Wound Gel
- K150815 — BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
- K151022 — Intraluminal Applicator Set
- K151062 — WASTON Metallic Intramedullary Nail System
- K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
- K151370 — UV Lamps for Indoor Tanning Devices
- K151810 — Bpump Blood Pressure Cuff
- K152115 — Renew NCP-5 External Counterpulsation System
- K152155 — ARCHITECT 2nd Generation Testosterone
- K152219 — PK AIM
- K152291 — Sterisheet Sterilization Wrap
- K152386 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K152442 — Freestyle Freedom Blood Glucose Monitoring Sytem
- K152491 — MoMe Software Platform
- K152636 — Laser Dock
- K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
- K152996 — Molteno3 Glaucoma Implant
- K153189 — Beacon Tissue Marker (SE)
- K153310 — Klassic Knee System
- K153344 — Asahi REXEED-S Series Dialyzer
- K150524 — Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
- K150806 — PulseFlowDF
- K150908 — XM-01 Electronic Automatic Blood Pressure Monitor
- K150992 — Vios Monitoring System
- K151279 — Counter OTC TENS Device, Model CSD-737Z
- K151840 — Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
- K152118 — Zenostar MT, Zenostar Color Liquids
- K152322 — Resolve 2.0
- K153362 — AquaShield system CO2, AquaShield system-PENTAX
- K153376 — Advanced Perfusion System 1
- K153450 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K153480 — ClearVue850 Diagnostic Ultrasound System
- K151063 — Monitor B40
- K151496 — Latitude-C Cervical Interbody Spacer System
- K152267 — Remedy® Shoulder Spacer
- K152513 — 8X-10-XXXX Camera System
- K152651 — AccuLIF TL and PL Cage
- K152945 — Alevicyn SG Antipruritic Gel
- K153483 — Balloon controller PB-30
- K150408 — V-STEADY, V-FAST
- K150769 — Cardinal Health Trochanteric IM Nail System
- K150782 — AbStats Gateway
- K150854 — ImmunoCAP Specific IgE +5 more
- K151611 — OneTouch Ultra Plus Flex Blood Glucose Monitoring System
- K151926 — QuickRay HD Intraoral Sensor
- K152172 — Econsole1
- K152202 — Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
- K152323 — Disposable Infusion Needle, Safelock Disposable Infusion Needle
- K152341 — ViSi Mobile Monitoring System
- K152554 — Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
- K152767 — OTC12D AUTO RADIOGRAPHIC SYSTEM
- K153122 — Endoskeleton(r) TCS System
- K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- K143013 — Spinal Inner Fixation System
- K143222 — FIREFLY Pedicle Screw Navigation Guide
- K143514 — Panther StereoSeed
- K150300 — Liquichek Cardiac Markers Plus Control LT
- K151114 — Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein
- K151381 — Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
- K151767 — Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
- K151900 — VariLift-L Interbody Fusion Device
- K151991 — Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
- K152153 — MicroSpot Handpiece
Data sourced from openFDA. This site is unofficial and independent of the FDA.