FDA 510(k) clearances — page 98
clearances on record, most recent first.
Clearances — page 98
9,701–9,800 of 176,479- K233185 — MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System
- K233348 — 16 Breast Coil
- K230281 — PICOCLAMP
- K230893 — Swiss LthoClast Trilogy
- K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
- K231732 — CleanSeal Advanced Bipolar Vessel Sealer Maryland
- K231764 — Ultrasound System 1300
- K232143 — Applanation Tonometer HT-5000
- K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
- K232205 — Vesco Q Enteral Feeding Pump +4 more
- K232305 — AI-Rad Companion Brain MR
- K232561 — Ripley Spinal Screw System by SAGICO
- K233258 — Shadow Knotless All-Suture Anchors
- K232091 — JO Coconut Hybrid Cooling Personal Lubricant
- K231539 — pRESET LITE Thrombectomy Device
- K223557 — SPECTRALIS HRA+OCT and variants
- K223909 — R2GATE Lite TM
- K230209 — Sonix Health
- K230983 — Unicare (K-UNICARE-USA)
- K230998 — Digital Wireless Intraoral X-Ray Sensor
- K231388 — NextDent Base
- K231578 — Lucitone Digital Print Denture System
- K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more
- K231902 — GAMMEX PI Hybrid Micro (8 models)
- K232042 — NexPort Trocar System (14 models)
- K232236 — Echo
- K232550 — Nitrile Examination Gloves, Dual Color Black-Blue
- K232552 — TuxDeluxe (Size 1 6100B, Size 2 6101B)
- K232922 — Pure-Vu EVS System
- K232951 — BioShield Biopsy Valve (00711124) +11 more
- K233065 — V-PRO maX 2 Low Temperature Sterilization System
- K230178 — EasyOne Sky Spirometer
- K230459 — C.C. Life 21
- K230476 — Oran Park Mask
- K230478 — Acro Composites Interbody System
- K231381 — Xpert Xpress MVP; GeneXpert Xpress System
- K231664 — IRRAflow Active Fluid Exchange System (AFES)
- K231704 — Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
- K231749 — Radio Frequency System
- K231976 — StealthStation Cranial Software, v3.1.5 (9735585)
- K232371 — Actinia® hip stems
- K232484 — KeyLift Expandable Interlaminar Stabilization System
- K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit
- K232910 — CombiDiagnost R90
- K230199 — Byte Aligner System
- K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
- K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M)
- K231225 — EConsole1
- K231395 — INNO SLA Submerged Narrow Implant System
- K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K231824 — SmartBolus Calculator
- K231826 — Omnipod 5 ACE Pump
- K231907 — Medline Safety Insulin and TB Syringes
- K232123 — MectaLIF Anterior Lag Extension
- K232524 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
- K232897 — Arthrex Small External Fixation System
- K232924 — T-Line® Hernia Mesh
- K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
- K223911 — Lumen 155-SF
- K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
- K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+
- K231899 — HAtetracell-C Titanium Cervical IBF System
- K232089 — SOZO Pro
- K232151 — Dynamic TiBase
- K232878 — TransLoc 3D
- K232903 — Legend X Platform
- K230104 — Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
- K230249 — Ikshana
- K230570 — Willow Generation 3 Breast Pump
- K231725 — Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
- K232020 — Iontophoresis Electrodes
- K232118 — ANDORATE® Valve Kit
- K232128 — Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
- K211676 — Motiva Flora SmoothSilk Tissue Expander
- K222143 — APIS (R), VERIS (TM)
- K223697 — MRI compatibility for existing BioHorizons dental implants and abutments
- K223863 — BONHAWA Respiratory Humidifier
- K230125 — Neuroblade System
- K230370 — SpotLight/SpotLight Duo (with DLIR option)
- K230440 — Xpert® Xpress CoV-2 plus
- K230495 — Serena Sleep Night Guard
- K230741 — Macro & Micro-Test HCG Pregnancy Test Midstream
- K231495 — The Evolve System with the Transform Applicator
- K231642 — Veuron-Brain-pAb3
- K231672 — S1
- K231744 — VyLink Spinal Screw System
- K232429 — Titan Dental Design
- K232437 — Paragon 8F Balloon Guide Catheter
- K232481 — RIGEL 3DR Anterior Cervical Corpectomy System
- K232504 — Calibrate CCX Interbody System
- K232822 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
- DEN200076 — ORi
- K222222 — Artemis, Artemis TPO, Artemis MX
- K230650 — Monopolar Electrode Surgical Instrument
- K230707 — Skypro, Surgical Gown 6021
- K230717 — Exactech® Vantage® Total Ankle System
- K231152 — Collagen Wound Dressing
- K231231 — MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
- K231475 — MONTAGE-QS Settable, Resorbable Bone Putty
- K231486 — Stable-L Standalone Lumbar Interbody System
Data sourced from openFDA. This site is unofficial and independent of the FDA.