FDA 510(k) clearances — page 359
clearances on record, most recent first.
Clearances — page 359
35,801–35,900 of 175,770- K142773 — EOS System
- K142932 — Deltex Medical KDP72 Doppler Probe
- K142945 — Sonoma Fibula Repair System
- K143247 — Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)
- K143718 — Mammography Color Display DP-M3010
- K140706 — LEVO MAX
- K141599 — DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
- K141707 — ULTRASKIN HYDROPHILIC GUIDE WIRE
- K142025 — NEUROLUMEN PN-1000
- K142104 — NANOFUSE DBM
- K142107 — ECHO TRUE 3D VIEWER
- K142360 — Everest Spinal System
- K142572 — Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
- K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
- K142791 — Spectra Soft Tissue Biopsy Needles
- K142860 — Lumenis M22 System
- K142866 — Myoscience iovera system
- K143065 — NuVasive ALIF Buttress Plate System
- K143299 — Percuvance(R) Percutaneous Surgical System
- K143366 — ADVANCE Porous Coated Spiked Tibial Base
- K140037 — OPTIMUS CMF SYSTEM
- K140736 — STERISAFE HP TABLE-TOP STEAM STERILIZER
- K140898 — PATIENT SPECIFIC DISTAL FEMORAL
- K142109 — STERILUCENT STERILIZATION CONTAINER SYSTEM
- K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM
- K142825 — Zmachine
- K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System
- K143037 — SnapShot Fixation System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.