FDA 510(k) clearances — page 60
clearances on record, most recent first.
Clearances — page 60
5,901–6,000 of 175,620- K242154 — Numen Coil Embolization System; NumenFR Detachment System
- K242276 — CrossFAST Integrated Microcatheter Guide Extension System (CFM55)
- DEN240017 — ShortCut
- K233446 — AMC Health CareConsole
- K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
- K240220 — Aulisa Temperature Module (TM0002)
- K240369 — CAC (gated) Algorithm
- K240745 — ID Free Personal Lubricant
- K240993 — encevis (2.1)
- K241447 — iCare ST500 (TA04)
- K241480 — JBS-LVO
- K241513 — Sourcerer
- K241536 — trophon Wireless Ultrasound Probe Holder
- K241909 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K241916 — TearRepair Liquid Skin Protectant
- K241933 — HIGHERDOSE Red and Infrared Light Mask (MK66-L)
- K241939 — EasyCare Tx 2
- K242125 — Elvie Stride 2
- K242206 — ACTIVO
- K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
- K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
- K242557 — ClotTriever XL Catheter (41-102)
- K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938
- K242582 — Optima Coil System (OptiBlock Line Extension)
- K234149 — MOLLI 2 System
- K240854 — Accelerate Arc System
- K241027 — Permatage Settable Bone Putty
- K241101 — BioButton System
- K241147 — Any-Com
- K241216 — myAir
- K241341 — cryo-GO Vitrification Device
- K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
- K241651 — Affixus Tibial and Antegrade Femoral Nailing System
- K241815 — Protean Fragment Plating System
- K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)
- K241895 — Cannulated PsiFGuard
- K242632 — Verifine® Pen Needles
- K240041 — IVD CAPSULE PSP; abioSCOPE
- K240042 — MOLLI 2 System
- K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
- K241535 — Vybe RF II
- K241860 — Diode Laser Hair Removal System
- K242075 — Indigo® Aspiration System Lightning Bolt Aspiration Tubing
- K242204 — Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
- K242273 — Cove Putty, OsteoCove Putty
- K242299 — NovaBone Putty - Synthetic Bioactive Bone Graft
- K233807 — LumiVy Lumbar IBF System
- K234134 — AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
- K240236 — Happy Ring Health Monitoring System
- K240776 — Celsio Flexible Cryocatheter System
- K241874 — Aspiration Catheter (2189)
- K242070 — Ion Endoluminal System (IF 1000)
- K242292 — uAI Easy Triage ICH
- K240013 — EchoGo Heart Failure (2.0)
- K240243 — EConsole2
- K241570 — Unity Total Knee System
- K241834 — IPL Hair Removal Device (BE932C, BE932D, BE932E)
- K232670 — HiCardi+ H100
- K233153 — Traus SSG10 Surgical System
- K234108 — ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
- K234129 — Ecomed Disposable Administration Sets
- K240036 — PIUR tUS Infinity
- K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
- K240420 — NeuroField Analysis Suite
- K240604 — MTONE EVO (MTONE EVO)
- K240722 — Derma-R Cream (Derma-R Cream)
- K241332 — aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device
- K241821 — Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
- K241825 — Microwave Ablation Antennas
- K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
- K242147 — Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
- K242223 — SuperSonic HepaVu
- K242504 — Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
- K242650 — zLOCK Lumbar Facet Fixation System
- K234096 — MonoStereo
- K240183 — Star E900 Handpiece Series
- K240901 — Stethophone
- K241465 — Midas Flowmeter; eAVS
- K241709 — Pectus Blu Support Bar System
- K242162 — Coconut Hybrid
- K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent
- K242478 — GF85 (models GF85-3P, GF85-SP)
- K242509 — HAnano InterFuse(R) Modular Interbody
- K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- K231893 — LOWTEM Crystal 120
- K233064 — Copra Supreme
- K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
- K234153 — EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
- K241123 — Perpak Sterilization Tyvek Pouch
- K241424 — InnoCare Specialty Foley Catheter
- K241769 — Response Ortho Metaphyseal Hinge Fixator System
- K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement
- K241784 — Arrow® Nitinol Wire
- K233721 — KLS Martin Drill-Free MMF Screw
- K234132 — Medline Reusable Sterilization Wrappers
- K240250 — 3D Printed PEEK Interbody System
- K240274 — PADLOCK CLIP EFTR Kit (00713229)
- K240293 — STS
- K240373 — Air compression Leg Massager (MM0520, MM0521, MM0522)
- K240660 — Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
Data sourced from openFDA. This site is unofficial and independent of the FDA.