FDA 510(k) clearances — page 68
clearances on record, most recent first.
Clearances — page 68
6,701–6,800 of 176,479- K240074 — Single use flexible ureteroscope (4 models)
- K240376 — Electroporation System (N3000)
- K240553 — LVivo Software Application
- K240675 — Endoscopic Injection Needles
- K241052 — Bladeless Trocar; Bladed Trocar; Hasson Trocar
- K241245 — EchoSolv AS
- K241298 — QUADSENSE
- K241434 — Video Ureteroscope System
- K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF +4 more
- K241796 — TroCare TroKit Laparoscope Lens Wiper (CP000626)
- K241854 — Power Wheelchair
- K241869 — BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
- K242106 — AuST Steerable Sheath
- K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
- K242343 — BPS Wrist Fracture System
- K242351 — Zeta Cranial Navigation System (ZNS131-US)
- K242364 — IdentiTi II Interbody System
- K242652 — Lunit INSIGHT DBT v1.1
- K242671 — Treace Medical Concepts (TMC) Screw Fixation System
- K242679 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (3 models)
- K242721 — Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
- K233497 — Rest Assure System
- K240393 — Exactech® TRULIANT® Knee System
- K240586 — Additive Manufacturing Zirconia Customized Restoration
- K240808 — Pulse Oximeter (WS20A)
- K241472 — Icona Hip Stem
- K241977 — Injectable Root Canal Bioceramic Sealer (i-MTA SP)
- K242507 — OBSIDIO Conformable Embolic
- K242616 — Lantern® Hip
- K242660 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
- K240153 — Ceramic Etchant (HF-5 and HF-9)
- K240529 — 8F Modified Sheath System
- K240889 — ARTFX Lumbar PEEK Cages
- K241097 — Arthrex Virtual Implant Positioning (VIP) System Software
- K241487 — Interwedge® Standalone Lateral
- K241561 — MammoScreen BD
- K241907 — Anovo Surgical System (model 6N)
- K241925 — VitruvianScan (v1.0)
- K242005 — Versana Premier; Versana Premier Lotus; LOGIQ F
- K242302 — RejuvaKnee Collagen Meniscus Implant
- K242377 — REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
- K242613 — NxTAG® Respiratory Pathogen Panel
- K240331 — Electric wheelchair (YHWL002, YHWL003)
- K240917 — Esperance 3+ Aspiration Catheter System
- K240943 — LungVision
- K241285 — Disposable Endoscope Valves Set (AF series)
- K241331 — MuscleView
- K241967 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.
- K242277 — Crown HT
- K242498 — Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
- K242651 — GM85
- K242678 — Definium Pace Select ET
- DEN230011 — OcuCool
- K210933 — YSI 2900C Biochemistry Analyzer
- K241151 — LUXEN 5G
- K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- K241657 — MSFX MIKRON SPINAL FIXATION SYSTEM
- K241836 — Kem Medical Lead-free Chemical Indicators for Steam Sterilization
- K241952 — AQUABEAM Robotic System (AB2000)
- 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) +1 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.