FDA 510(k) clearances — page 95
clearances on record, most recent first.
Clearances — page 95
9,401–9,500 of 175,620- K231407 — StarFin
- K232226 — ARROW Off-Centred Humeral Insert
- K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
- 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); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
- 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
- K230976 — Arthrex Radiopaque FiberTape Cerclage sutures
- K231274 — Natural Cycles
- K231506 — Current Health System
- K231557 — ZENEX FreeMilling & CCM Cast Abutment
- K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws
- K231604 — Instrument Case
- K231680 — AccelFix Lumbar Expandable Cage System
- K231944 — CATAMARAN SI Joint Fusion System
- K232215 — Quantra Hemostasis Analyzer
- K232218 — Zenius Spinal System
- K232291 — Essenz HLM, Essenz ILBM
- K222946 — Oneday Mini Implant System
- K223590 — Access Folate Assay
- K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
- K230610 — Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
- K230812 — Withings Scan Monitor 2.0
- K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack
- K232243 — EVO 700 series high speed handpiece
- DEN220052 — BrachyGel Vaginal Hydrogel Packing System
- K220938 — Nova HD+
- K223574 — IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
- K230899 — qXR-PTX-PE
- K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
- K231496 — TITAN 3-D Wedge System
- K231503 — CUPTIMIZE Advanced
- K231510 — Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
- K231811 — Zavation Connector System
- K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
- K222245 — ACR Screw System
- K223560 — Plato 17 Microcatheter
- K223813 — Aveta System 2.0
- K230486 — Cove Strip
- K231266 — Pediatric Nailing Platform Tibia
- K231731 — Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
- K231763 — Stable-C Interbody System
- K231867 — Grappler Suture Anchor System
- K232185 — SM-IV
- K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)
- DEN230019 — AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
- K220253 — Eco Abutment, Multiunit Abutment
- K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
- K223163 — Sleepiz One+
- K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
- K223539 — Dreem 3S
- K223573 — Onera Sleep Test System (Onera STS)
- K223867 — IDS ACTH II
- K223883 — Daye Tampon
- K230579 — Smart Wedge algorithm
- K231026 — 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
- K231053 — Unicare (K-UNICARE-USA)
- K231085 — 1.5T HD T/R Knee Array (10-F34127)
- K231096 — Automatic Continuous Effusion Shunt (ACES) System ACES System
- K231204 — Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App
- K231257 — Pangea Utility Plating System, Pangea Platform
- K231262 — Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
- K231457 — SPARK Scan
- K231673 — P200TE (A10700)
- K231718 — Holmium Medical Laser
- K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
Data sourced from openFDA. This site is unofficial and independent of the FDA.