FDA 510(k) clearances — page 103
clearances on record, most recent first.
Clearances — page 103
10,201–10,300 of 176,479- K223622 — FaceHeart Vitals Software Development Kit (FH vitals SDK)
- K223674 — eZSURE Empty Fluid Container (models 426030, 426040, 426110)
- K223901 — ApneaRX Pro
- K230317 — Elos Accurate Hybrid Base
- K230623 — KITE Distal Fibula Kit
- K230805 — TriMed Clavicle Fixation System
- K230918 — MasterX 800 Series
- K231047 — UniSyn Molecular Imaging (6-3-1)
- K231270 — Montage Flowable Settable, Resorbable Bone Paste
- K231710 — OW100S
- K231884 — TRIOCLEAR System
- K232014 — CONDUIT ATP Inserters
- K232021 — Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
- K232068 — HyperLight Portable X-ray Unit
- K232314 — Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
- K232334 — DEKA SIMON
- K232340 — Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
- K232657 — InnerView LC
- K213271 — MedicloseTM System
- K221959 — Q21
- K222563 — BD Kiestra IdentifA
- K223527 — Little Wave Clik, Rogue XP, Little Wave XP, Spark
- K223533 — Little Wave Arc; Little Wave Flip
- K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- K230488 — EL27-Compact; Sterile EHL-Probes
- K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
- K231323 — Ancora-SB
- K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
- K231611 — HOLO Portal Surgical Guidance System
- K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- K231626 — OSPREY Closed IV Catheter System (OspreyV2)
- K231978 — BioSieve Marijuana Test Panel 50 +5 more
- K232287 — RAYSCAN a-Expert3D
- K232353 — Powder Free Nitrile Examination Gloves (Black)
- K213418 — MONTAGE Settable, Resorbable Hemostatic Bone Putty
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
- K223303 — Spinery RF Ablation System
- K223367 — Ochsner Connected Inhaler Sensor
- K223468 — Nexis® compressive screws
- K230013 — Silk'n Titan Allways
- K230155 — Mick Valencia Applicator Set
- K230355 — Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
- K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more
- K231024 — AquaBeam Robotic System
- K231093 — AlphaVent Suture Anchors
- K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01) +2 more
- K231156 — Enzyme Packed Cartridge - RELiZORB
- K231246 — Ventrax Delivery System (VTR851)
- K231276 — SmartCardia 7L Platform
- K231289 — S-Patch Ex Wearable ECG Patch
- K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
- K231656 — Brainomix 360 e-MRI
- K231961 — NIBPCuff
- K231988 — Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
- K232295 — LAA Exclusion System
- K232324 — StealthFix Intraosseous Fixation System
- K232343 — AC3 Series IABP
- K221361 — circul pro Ring
- K230765 — Precice Ankle Salvage System
- K231407 — StarFin
- K232226 — ARROW Off-Centred Humeral Insert
- K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420) +1 more
- K222525 — Alveoair Digital Spirometer
- K223639 — VisAble.IO
- K230159 — SoundBite® Crossing System XS Peripheral
- K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
- K231422 — Precision GI
- K231435 — KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K231537 — SofWave System
- K231623 — Distal Elbow Plating System
- K231676 — CALLISTO eye
- K232387 — Treace Medical Concepts (TMC) Compression Implant System
- K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
- K222786 — 072 Aspiration System
- K222972 — BioProtect Balloon Implant System
- K223180 — AIRAscore
- K223600 — Sterilization Wrap
- K223727 — Lavieen
- K223807 — Reusable Temperature Probe, Disposable Temperature Probe
- K223898 — VitalFlowTM Centrifugal Pump
- K230014 — MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
- K230094 — Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
- K230165 — Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
- K230364 — VitalFlow Console
- K230409 — Wrist Type Blood Pressure Monitor (W05,W1101L)
- K230566 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
- K230928 — Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
- K231183 — Non absorbable Surgical Polyester Suture
- K231255 — NovoFine® Plus
- K231872 — Polaris Bipolar Electrosurgical Generator (29-1000) +3 more
- K231903 — Montage-QS Settable, Resorbable Bone Putty
- K231994 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
- K232214 — OMNI Surgical System
- K212766 — Maxiocel Chitosan Wound Dressing
- K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
- K220145 — Monaghan medical filtered mouthpiece kit
- K222103 — Nitrile Patient Examination Gloves, Powder Free, Pink Color
- K223150 — APS Metal Plate & Screw System
- K223606 — LifeShield Infusion Safety Software Suite
- K223607 — Plum Duo Infusion System
Data sourced from openFDA. This site is unofficial and independent of the FDA.