FDA 510(k) clearances — page 86
clearances on record, most recent first.
Clearances — page 86
8,501–8,600 of 175,620- K232033 — HYBRIDknife® flex
- K232069 — Expandable Lumbar Fusion Cage (Type I,Type II)
- K232244 — Disposable Endoscope Valves System
- K232684 — Surgify Halo
- K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)
- K233527 — Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
- K233532 — MULTIX Impact E
- K222845 — Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
- K230883 — VersaPump Infusion System
- K230947 — C.A.R.E. Appliance (DNA, mRNA, mmRNA)
- K231250 — Digital Blood Pressure Monitor
- K231473 — Monarch Bronchoscope
- K231631 — BriefCase-Quantification
- K232000 — syngo.via MI Workflows; Scenium; syngo MBF
- K232012 — N1
- K232117 — Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
- K232252 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
- K232595 — Kinos Axiom Total Ankle System
- K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
- K232643 — Cue COVID-19 Molecular Test
- K232713 — Blood Pressure Monitor
- K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System
- K233493 — Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)
- K230379 — Portable (Ultrasonic) Nebulizer
- K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
- K231104 — ABPMpro
- K231661 — CryoThin Surgical System and Accessories
- K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
- K232624 — CardioPhase® hsCRP
- K232658 — T-Top 10 & T-Top T-Top 11
- K233171 — PF Keep; Cad Cam Keep Block
- K233243 — ClearPoint System (Software Version 2.2)
- K233332 — Statera-C Spinal System
- K233343 — SteriCap Safety Needle; VitreJect Safety Needle
- K233160 — NeuTrace EP Mapping System v.2.1
- K230311 — HyperSuture
- K230319 — Passio Pump Drainage System
- K230701 — Stim2Go
- K232059 — Tympanostomy Tubes
- K233525 — MF SC Facial Toning System
- K222499 — Disposable Endoscope Valves Kit
- K222712 — Fogg System Patient Monitoring Cables
- K230529 — HealiAid Dental Collagen Wound Dressing
- K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
- K231245 — Digital Blood Pressure Monitor (Arm Type)
- K231797 — Medifun Lancing Device, Model No. LD-E1
- K232593 — FITme Customized Silicone Implant
- K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels
- K232621 — Blood pressure monitor
- K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
- K233078 — Posterior Cervical Spine System
- K233110 — Carnation Ambulatory Monitor
- K221606 — Absorbable Cranial Flap Fixation System
- K222511 — Oxy2Pro
- K223615 — Digital ClarusScope System, Digital NeuroPEN System
- K230211 — CranioXpand
- K230287 — SaviSafe Safety Device
- K230641 — Ultrasonic Scaler Tips
- K230773 — Endoscopy Irrigation Tubing
- K230834 — CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
- K231443 — Mini-OSTEO Pedicle Fixation System
- K231975 — PNK Total Knee System
- K232001 — Nu Skin RenuSpa iO
- K232388 — High Pressure Tubing
- K232496 — Brainomix 360 Triage Stroke
- K232546 — Meta G UCLA Abutment
- K232549 — NemoCast
- K232573 — INFINITI Ambi Angiographic Catheter
- K232576 — Medical Nitrile Examination Gloves
- K232719 — ProMIS Extension Rod System
- K232898 — Quantisal Oral Fluid Collection Device
- K232977 — Biophotas Celluma CONTOUR
- K232988 — Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
- K233010 — Beagank 4T Plus
- K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator
- K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
- K233084 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
- K233191 — TotalTi ACDF by SAGICO
- K233245 — MagnetOs Flex Matrix
- K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
- K230627 — Zilia Ocular FC (ZIL-10002)
- K230700 — RIWOtrack Navigation System
- K231498 — TraumaCad Neo
- K231692 — Ziehm Vision RFD
- K231941 — ARIETTA x10
- K232545 — The SensiTox B. anthracis Toxin Test
- K232555 — Harmony
- K232575 — Hair Removal Device, Model(s): R2815-G Pro, R2815-G
- K233346 — Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);
- K233351 — Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force
- K230190 — Polyver Silver Alginate Dressing (Prescription and OTC)
- K230589 — Celox Rapid X-Ray Gauze
- K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin
- K230954 — Samfilcon B Custom Contact Lens
- K231020 — Alinity c Tricyclic Antidepressants Reagent Kit
- K231559 — Multi-Unit DAS System
- K231600 — SENDERO Microcatheter
- K232028 — Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
- K232501 — AI Platform (AIP001)
- K232512 — Masimo W1
Data sourced from openFDA. This site is unofficial and independent of the FDA.