FDA 510(k) clearances — page 313
clearances on record, most recent first.
Clearances — page 313
31,201–31,300 of 176,542- K161417 — DePuy Synthes MAXFRAME Multi-Axial Correction System
- K161623 — Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
- K161628 — JAS Pulse(TM) Ultrasonic Therapy
- K161634 — IPS CaseDesigner
- K161738 — FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
- K162085 — i-CAT FLX V series / KaVo 3D eXam+ V series
- K162310 — XBraid TT Suture Tape
- K162539 — Solitaire 2 Revascularization Device
- K162576 — FORTEZZA Spinal Stabilization System
- K162656 — ESU-1 Electrosurgical Generator
- K152660 — HYPNOSPAD
- K160481 — Vivo 60
- K161433 — Insulia Diabetes Management Companion
- K161610 — EXPRT Revision Hip System
- K161649 — Virtu C Spinal Implant System
- K161768 — LUCAS 3 Chest Compression System
- K162262 — Tritanium® PL Cage
- K162781 — Magma Spark
- K162862 — Raycast High Precision Lung Board Solution
- K160924 — Amendia Interbody Fusion Devices
- K161011 — SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
- K161027 — Cadwell AmpliScan
- K161438 — Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
- K161493 — YO Home Sperm Test
- K160446 — MCP Bone Putty
- K161254 — Renovo Life Small Bone IM Nail System
- K161624 — MicrO2 OSA Device with Micro-Recorder
- K161638 — SPEEDTRAP Graft Preparation System
- K161952 — UltraShape System
- K162113 — Powder Free Nitrile Examination Gloves (Blue)
- K162257 — P1145 Dental Restorative
- K162273 — Materialise TKA Guide System
- K162863 — dS Small Extremity 16CH 1.5T Coil
- K162944 — Irix-C Cervical Integrated Fusion System
- K160153 — ABL90 FLEX PLUS
- K160278 — VSTAAR AdjusteR
- K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
- K160979 — Inclusive Abutments
- K161357 — LipiFlow Thermal Pulsation System
- K161636 — Lipogems System
- K161646 — Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
- K161703 — LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
- K161740 — D-SPECT Scanner, D-SPECT L Scanner
- K161913 — AOS Small Fragment Plating System
- K161921 — SwiftNINJA Microcatheter
- K161935 — Avance Foam Dressing Kit - XL
- K162162 — Barrier Supreme Sterilization Wrapper
- K162284 — Puritan Fecal Opti-Swab Collection and Transport System
- K162350 — Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
- K162440 — CardioInsight Cardiac Mapping System
- K162573 — Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
- K162585 — SuniIQ Digital Radiography System
- K162595 — Trex_HD
- K162619 — I View and Imagen Sensor
- K162769 — Pinpoint GT Introducer Needle
- K152615 — Vonflex S
- K160180 — Intermittent Pneumatic Compression system
- K160349 — Electronic Sphygmomanometer
- K160437 — PleurX Peritoneal Catheter System
- K160532 — Greiner Holdex
- K160921 — CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
- K161131 — FONA Pan/Ceph
- K161157 — Vitrea CT Dual Energy Image View
- K161174 — Nanova Interference Screw
- K161373 — Nunchaku
- K161590 — MatrixRIB Fixation System
- K161592 — Persona Partial Knee System
- K161779 — MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
- K161948 — Avance Gauze Dressing Kits
- K161968 — MicrUs
- K162136 — CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
- K162268 — Senographe Pristina
- K162801 — CastleLoc Spinal Fixation System
- K160421 — Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
- K160561 — Boosting Catheter
- K160746 — CARDIOLINE touchECG
- K161370 — Durepair Dura Regeneration Matrix
- K161378 — joimax Electrosurgical Instruments
- K161670 — Lucid Q-PTP / HWA 55
- K162095 — Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
- K160895 — Initia Total Hip System & BIOCERAM AZUL(R) HEAD
- K161454 — Propeller Sensor Model 2015-E
- K161620 — Anatomical Shoulder Domelock Dome centric
- K161974 — SLENDERTONE® Connect Abs, Type 570
- K162002 — Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
- K162062 — AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
- K162155 — Xario 200 Diagnostic Ultrasound System V5.0
- K162358 — T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
- K162453 — 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
- K152472 — Disposable Pressure Transducer
- K160141 — miraDry System
- K160450 — Pleurx Pleural Catheter System
- K161448 — Footmotion Plating System
- K161483 — Unger Quad Injector
- K161851 — Glass Ionomer Cement (Luting)
- K162150 — BreathID Hp Lab System
- K162741 — AxoGuard Nerve Connector
- K162777 — Squirt Fluid Delivery System
- K161282 — FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
- DEN160001 — BD MAX Vaginal Panel, BD MAX Instrument
Data sourced from openFDA. This site is unofficial and independent of the FDA.