FDA 510(k) clearances — page 91
clearances on record, most recent first.
Clearances — page 91
9,001–9,100 of 175,620- K232755 — Arthrex FiberTape and TigerTape Cerclage Sutures
- K232760 — Swoop® Portable MR Imaging System®
- K232787 — ScanNav Anatomy Peripheral Nerve Block
- K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
- K221550 — Evidence MultiSTAT DOA Urine MultiPlex
- K223740 — Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
- K230070 — MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®
- K230242 — OsteoCentric Dental Implant System
- K230780 — MFG-05
- K231001 — DeepTek CXR Analyzer v1.0
- K231078 — All-Suture Anchor
- K232279 — LifeStyles NRL Textured Condom
- K232367 — cmAngio® V1.0
- K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
- K232675 — Heating Tens, FT-615
- K232704 — Clarius Ultrasound Scanner
- K233044 — Tandem Mobi insulin pump with interoperable technology
- DEN230002 — DuraGraft
- K230135 — Copioumed Chemotherapy Isolation Gown
- K231025 — EFAI NeuroSuite CT ICH Assessment System
- K231398 — VUNO Med-DeepBrain
- K231567 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
- K232023 — Momentum Spine
- K232763 — Electrode Handpieces (VCT, RFTV, BMDT series)
- K232767 — Nautilus VF ECMO Oxygenator
- K232844 — The IQoolTM System
- K230085 — Lung-CAD
- K231772 — V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
- K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
- K232094 — Orchid Safety Release ValveTM
- K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)
- K232406 — KARL STORZ OR1 SCB CONTROL (WU300)
- K232712 — uMI Panorama
- K232722 — endo.digital Platform
- K232762 — dS Breast Coil 7ch 1.5T
- K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
- K232918 — enspire 300 Series Automated Endoscope Reprocessor
- K221972 — Warantec Custom Abutment
- K230681 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
- K231520 — tmCMF Solution
- K231716 — OsteoFlo® HydroPutty
- K232064 — Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
- K232359 — Surgical face mask
- K221890 — Elecsys Tg II
- DEN210011 — Invitae Common Hereditary Cancers Panel
- DEN210056 — Procise IFX
- DEN220023 — Procise ADL
- K212769 — DYNEX SmartPLEX MMRV IgG Assay Kit
- K213403 — Aptiva CTD Essential Reagent
- K220458 — UltraFlo-R Push Button Blood Collection Set
- K221274 — StarFormer, TightWave
- K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
- K221508 — AnemoCheck Home
- K221570 — Antibacterial bandage
- K221900 — Stat Profile Prime Plus Analyzer System
- K223085 — Miris Human Milk Analyzer (HMA)
- K223873 — Boppli Infant Blood Pressure Monitor
- K230045 — HipCheck
- K230187 — Terran NM-101
- K230591 — TriLEAP Plating System
- K230847 — Chemotherapy Gloves
- K231527 — TriALTIS Navigation Enabled Instruments
- K231622 — REGER Nebulizer Irrigation Cannula
- K231628 — BeShape One Device
- K231649 — Intraosseous Fusion Device System
- K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
- K231957 — SafeBreak® Vascular
- K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
- K232299 — CeraPutty
- K232647 — Microcatheter
- K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
- K232669 — TBI
- K232690 — Amulet Steerable Delivery Sheath
- K232701 — Guardenia (GAR-1)
- K233257 — 3M ClarityAligners with Quick Attachments
- K230865 — PIVO Pro Needle-free Blood Collection Device
- K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit
- K231188 — ALIGN Radial Head System
- K231792 — VeriSafe Safety sterile syringes
- K231837 — Brainomix 360 Triage LVO
- K231901 — Hakon, Hakon Smart
- K232274 — IPL hair removal device
- K232605 — Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
- K232699 — Low Ejection Fraction AI-ECG Algorithm
- K233161 — BeautiLink SA
- K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
- K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
- K230563 — EVOLUTION® Hinge Knee System
- K230925 — Disposable Injection Needle AF series
- K231007 — CEDIA Heroin Metabolite (6-AM) Assay
- K231076 — VariLift®-C Interbody Fusion System
- K231108 — Talon Transseptal Sheath
- K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- K231538 — FreedomFlow Orbital Circumferential Atherectomy System
- K232167 — VySpan PCT System
- K232255 — EZSensor XHD
- K232260 — Thinline Sheath Introducer
- K232275 — Invictus® Spinal Fixation System
- K232596 — EndoGI S-Path Biliary Stent System
Data sourced from openFDA. This site is unofficial and independent of the FDA.