FDA 510(k) clearances — page 252
clearances on record, most recent first.
Clearances — page 252
25,101–25,200 of 176,542- K182501 — Hair Laser Headband
- K182753 — A6 OTC Pain Relief TENS
- K182767 — V2 OTC Pain Relief TENS
- K170723 — Swaive Thermometer SWT1A
- K173944 — Endocular Viewing Lenses and Silicone Ring
- K180258 — SpeediCath Standard
- K180688 — SLENDERTONE CoreFit Abs 8, Type 734
- K181116 — CONVIVO
- K181186 — Solitare Platinum Revascularization Device
- K181354 — 074 Zenith Flex System
- K181468 — Hybrid3D
- K181685 — Vivid E80, Vivid E90, Vivid E95
- K181902 — Codman Certas Plus Electronic Tool Kit
- K181936 — DyeVert PLUS EZ Contrast Reduction System
- K181947 — Persona Revision Knee System
- K182171 — SMV Scientific K-Wire and Pins
- K182464 — PeekMed
- K182706 — External upper limb tremor stimulator
- DEN180004 — picoAMH ELISA
- K173603 — Monarch Airway Clearance System
- K173756 — Certus 140 2.45GHz Ablation System
- K180275 — VAMP Optima closed blood sampling system
- K180302 — Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter
- K180605 — GastroFlush
- K180758 — Osteocera Resorbable Bone Substitute
- K180788 — Gas Module 3
- K180940 — KODEX EPD System
- K181530 — World Total Knee System
- K181560 — Cios Alpha
- K181596 — Spine Wave Navigated Instruments
- K182140 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K182281 — Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
- K182318 — Retina Workplace
- K182322 — Duo Lumbar Interbody Fusion Device
- K182365 — TempSure System
- K182647 — GC70
- K172670 — BD Single Use, Hypodermic Syringe
- K173824 — Humeral Short Stem System
- K180046 — Masimo Rad-97 and Accessories
- K180622 — Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
- K181964 — JiveX
- K182002 — Cumulus Remover
- K182042 — Randox Calcium (Ca)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.