FDA 510(k) clearances — page 244
clearances on record, most recent first.
Clearances — page 244
24,301–24,400 of 175,699- K182106 — BTL 799-2T
- K182283 — FUSE Pedicle Screw System
- K182529 — Xperius Ultrasound System
- K182622 — GU60A, GU60A-65
- K172533 — GM Implant Tubes, Length Cutting Gauge
- K172733 — TD-1035 Thermometer
- K180554 — ANTHEM Fracture System
- K181192 — PIP Fix
- K181248 — Comarch e-Care Platform
- K181254 — Quadra P
- K181566 — Nutrifill
- K181922 — Sonendo Material A
- K181223 — ImPACT
- K173594 — Straumann cerabone
- K180202 — Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
- K180205 — AVELLE Negative Pressure Wound Therapy System
- K180213 — Titanium TomoFix Medial High Tibia Plate Anatomical
- K180516 — EchoS
- K181433 — MAGNETOM Vida
- K181621 — Stable-C Interbody System
- K182264 — ICONN Revolution Knotless Suture Anchor
- K182282 — Vantage Orian 1.5T, MRT-1550, V4.5
- K182450 — Vivid S60N, Vivid S70N
- K182561 — UroNav (Version 3.0)
- K182586 — DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
- K182590 — 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
- K182644 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
- K182735 — Paragonix SherpaPak Cardiac Transport System
- K180474 — TNI softFlow 50
- K180708 — Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
- K181373 — Extended Lipid Panel Assay
- K181618 — Reprocessed Torqr Diagnostic EP Catheter
- K181718 — BD FlowSmart Set/MiniMed Pro-Set
- K181803 — Medax Biopsy Systems III
- K181941 — Swift System
- K181942 — Quantum Ventilation Module
- K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z
- K182239 — OLYMPIC Posterior Spinal Fixation System
- K182348 — 14HK701G-W
- K182569 — Spectralis HRA+OCT and variants with High Magnification Module
- K182591 — RadiForce RX360, RX360-AR
- K172709 — ELAN 4 Electro Motor System Tools
- K180240 — Full Automatic(NIBP) Blood Pressure Monitor
- K180345 — Uroject12 Syringe Lever
- K180941 — Ortho System
- K181026 — OsteoBridge IDSF System
- K181728 — Muscle Trainer
- K182034 — Arterys MICA
- K182240 — PASS LP Spinal System
- K182546 — Alphenix, INFX-8000H/B, V8.0
- K182550 — Wireless Digital Flat Panel Detector
- K182551 — Wireless Digital Flat Panel Detector
- K182669 — Youlaser CO2
- K180568 — KidCap
- K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device
- K181937 — Pump In Style Advanced, Advanced Personal Double Breastpump
- K182154 — Depuy Synthes Femoral Neck System
- K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe
- K182614 — RCT700
- K180418 — Reliant(TM) Multistage Dilatation Balloon Catheter
- K181815 — DynaBridge
- K181910 — BracePaste MTP Light Cure Primer
- K182036 — NeuroBlate System
- K182233 — FlowTriever Retrieval/Aspiration System
- K180099 — Optilite High Sensitivity C-Reactive Protein Kit
- K180292 — PENTAX Video Upper G.I. Scope EG34-i10
- K180446 — b-ONE Total Knee System
- K180620 — Endophys Pressure Sensing Sheath Kit
- K180991 — AG 100s
- K181220 — Juell 3D Volo Base
- K181539 — OSSDSIGN Cranioplug
- K181569 — BKS Revision Sleeves System
- K181607 — Thorecon Rigid Fixation System
- K181640 — X-BOLT Hip Fracture Fixation System
- K181644 — EIT Cellular Titanium® Lumbar Cage LLIF
- K181651 — Radial Medical Compression System
- K181717 — Life Spine Laminoplasty System
- K181848 — ADAPT for Gamma3, Gamma3
- K181852 — Percuvance Percutaneous Surgical System
- K181999 — Integra TITAN Reverse Shoulder System
- K182129 — MAGNETOM Sola
- K182237 — uMI 550 PET/CT System
- K182247 — ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
- K182504 — 3.0T Air MP M, 3.0T Air MP L
- K182522 — Penumbra System (Modified 110 Aspiration Tubing)
- K182536 — Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
- K173920 — LS OIL
- K180249 — OmniPore DUROMAX Surgical Implants
- K180555 — Ergoline Prestige 1600 Hybrid Performance
- K180680 — Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
- K180872 — SCARLET SRF
- K181008 — NuFACE Trinity
- K181091 — AxSOS 3 Ti
- K181330 — NeoMatriX Wound Matrix
- K181426 — Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
- K181460 — OnePacs System
- K181503 — Fingertip Pulse Oximeter
- K181520 — Sirona Dental CAD/CAM System
- K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture
- K181617 — E-CUBE 8
Data sourced from openFDA. This site is unofficial and independent of the FDA.