FDA 510(k) clearances — page 367
clearances on record, most recent first.
Clearances — page 367
36,601–36,700 of 176,542- K143182 — Speedicath Compact Male
- K143317 — Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
- K143498 — LifeGlobal Global HP
- K143634 — MUSE System
- K142106 — DECISIO HEALTH PATIENT DASHBOARD
- K142749 — TruWave Disposable Pressure Transducer
- K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
- K133239 — ZOLL E SERIES
- K140580 — REVOLUTION FULLFACE MASK
- K141206 — EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
- K141379 — VICTUS FEMTOSECOND LASER PLATFORM
- K141561 — VM PACS WITH VM MEDICAL WORKSTATION
- K141608 — COLLAGEN DURA MEMBRANE
- K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
- K141921 — HIVOX SPOPAD EMS
- K142209 — Pulse oximeter NBM-200
- K142276 — MCS Bone Graft
- K142283 — Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
- K142583 — LaborView LV1000
- K142584 — iMAR
- K142590 — All Safe Huber Safety Infusion Set
- K142599 — PRECISE Trauma Nail System
- K142862 — POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
- K142897 — P200DTx
- K142922 — SpyGlass DS Direct Visualization System
- K142980 — Proficient (TM) Facet Screw Spine System
- K143006 — GUARDIAN-SG Inflatable Bone Expander System
- K143023 — Nitinol Compression Plating System
- K143039 — CrossRoads Screw System
- K143139 — Arthrex Fracture System
- K143166 — Medline ReNewal Reprocessed Compression Limb Sleeves
- K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
- K143298 — Ultrasound Scanner System bk2300
- K143573 — Audit MicroControls Linearity FD Tumor Markers II
- K143589 — GEM Flow COUPLER Device and System
- K143614 — Arthrex Low Profile Screws
- K132172 — NEONATALIE RESUSCITATOR
- K140471 — PRO X OTC 5
- K140957 — GENASIS HIPATH IHC FAMILY
- K141070 — SUPER SHEATH
- K141187 — IMPIX ALIF S/A
- K141224 — JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
- K141549 — SImmetry Sacroiliac Joint Fusion System
- K142144 — DISPOSABLE INJECTION NEEDLE
- K142475 — EVS 4343
- K142622 — IV Administration
- K142675 — CI../..X liner for NOVAE Dual Mobility Acetabular Cup
- K142703 — Powder-free PVC Vinyl Exam Gloves
- K142741 — OASYS System
- K142828 — osteoSPAN Morpheus
- K142935 — CareEvent
- K143007 — Erchonia Zerona Z6 OTC
- K143040 — Exilis XP
- K143311 — Pre-vacuum Tabletop Autoclave
- K143587 — ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
- K143625 — truFreeze System
- K142335 — RapidVac Smoke Evacuator System
- K142368 — NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
- K142553 — UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
- K142792 — AbbVie NJ
- K142793 — AbbVie PEG
- K142816 — AbbVie J
- K143068 — Medical Monofilament Sensory Screening Toool
- K143412 — ADROIT Guiding Catheter
- K143493 — SignosRT Bladder Ultrasound System
- K143504 — IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
- K143547 — Vivorte Trabexus EB
- K143549 — Vivorte Trabexus
- K141024 — EXTERNAL PULSE OXIMETER
- K142057 — INFIX CANNULATED SCREW SYSTEM
- K142722 — 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200
- K142759 — PK Cutting Forceps for ESG-400 Workstation
- K142939 — Revolution Spinal Fixation System
- K142948 — BIOSURE REGENESORB interference Screw
- K142952 — InMode Diolaze Device
- K143393 — Triathlon Tritanium Cone Augments
- K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone
- K143624 — Headless Compression Screw System
- K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K142641 — Intelliwave4
- K142914 — DacryoCATH
- K143223 — CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT
- K143522 — Presto Inflation Device
- K143588 — Surefire Infusion System 021
- K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
- K140046 — SPINOUS PROCESS FUSION (SPF) PLATE
- K141114 — BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
- K141132 — ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
- K141253 — NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
- K141398 — PASS LP SPINAL SYSTEM
- K141441 — MENNTOR X7
- K141465 — CARDIOGARD EMBOLI PROTECTION CANNULA
- K141622 — ILLUMINATED MEDIASTINOSCOPE
- K141783 — TDX SP2 POWER WHEECHAIR
- K142059 — FOX MOBILE
- K142363 — NUSTAT, NUSTAT XR
- K142366 — Puritan OptiTranz Liquid Stuart Collection and Transport System
- K142554 — Revolution Full Face Mask
- K142635 — Medline Silicone Foley Catheter
- K142890 — Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
Data sourced from openFDA. This site is unofficial and independent of the FDA.