FDA 510(k) clearances — page 94
clearances on record, most recent first.
Clearances — page 94
9,301–9,400 of 176,479- K233335 — Tablo® Hemodialysis System
- K233490 — SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty
- K233568 — Ceevra Reveal 3+
- DEN230045 — Sonu
- K220525 — RESPONDER Polysaccharide Hemostat
- K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
- K230648 — Access hsTnI
- K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
- K231895 — Maxtec MaxBlend2+p
- K232308 — Monarch Blood Collection Set
- K232581 — Medical Disposable Sterile Needle Electrode
- K232693 — Tyber Medical Distal Radius Plating System
- K232932 — Intense Pulse Light Therapeutic Apparatus
- K233347 — Verruca-Freeze® H
- K233397 — Cosine-10TM Diagnostic Catheter
- K230391 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube
- K230528 — Extension Set
- K230621 — LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes
- K230639 — Align Cervical Interbody Fusion System
- K230988 — Vial2Bag Advanced® 13mm Admixture Device
- K231057 — Antibacterial Gel Wound Dressing
- K231179 — Slinky Catheter
- K231211 — Medline ComfortTemp Patient Warming System
- K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
- K231476 — TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System
- K231817 — AlignerFlow LC
- K232093 — Woo More Play Coconut Love Oil
- K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14
- K232418 — Single Platform SP1 Implant System
- K232438 — Dental Glass Ceramics Blocks
- K232708 — Intense pulsed light therapy device
- K232758 — Comatryx OTC
- K232856 — Syngo Carbon Clinicals
- K233149 — CATHTONG III Tapered PICC Catheter
- K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
- K233301 — ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
- K233529 — BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
- K221787 — Auxein's DHS/DCS Plate System
- K230061 — Insulin Syringe
- K230587 — Wrist Pulse Oximeter
- K230669 — L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters
- K231393 — Radical the Dude 7F Guide Catheter
- K231546 — Somfit
- K231877 — NavaClick Injection System
- K232155 — syngo.CT Dual Energy
- K232262 — LumenEye® X1 endoscope (LX1-SCP-203) +2 more
- K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
- K232709 — Diode laser therapy device
- K232716 — Q-Switched Nd:Yag laser
- K233500 — Benesta Tissue Removal Device
- K233503 — 14F iSLEEVE Introducer Set
- K233545 — EPIQ Series Diagnostic Ultrasound System
- K233552 — IDEAL Ziploop
- K230179 — 6440 MyLabX90
- K230646 — SUREcore Prime Biopsy Instrument
- K230726 — CEREGLIDE 92 Intermediate Catheter
- K231203 — Mosie Baby Kit
- K231482 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
- K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
- 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 +3 more
- 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 +10 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.