FDA 510(k) clearances — page 59
clearances on record, most recent first.
Clearances — page 59
5,801–5,900 of 175,620- K241735 — ProSeal In Line Pump Set (423850)
- K241951 — Lasya-Trinity
- K242389 — EyeGility Inserter for Preloaded enVista IOLs
- K242400 — Dental porcelain powder
- K242515 — uDR 380i Pro
- K231948 — MEDIYAG
- K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
- K240181 — Clavicle and Scapula System
- K240991 — eMVFit (MVF-10M)
- K241355 — SER Pen Carain MicroSystem (MP1209SP)
- K241477 — aprevo® anterior lumbar interbody fusion device with interfixation
- K241485 — TruAbutment DS; TruBase
- K241837 — Limbus Contour
- K242021 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.
- K242029 — TRAP EASY
- K242691 — OsteoCentric Technologies Cannulated Fasteners and Nuts
- DEN230076 — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))
- K240167 — Single-use Ureteral Access Sheath
- K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
- K240563 — Power Wheelchair (JJW-6001)
- K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
- K241446 — Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
- K241756 — Nerivio; NerivioInfinity
- K242014 — Jet Flow Bulk
- K242267 — Gemini Medical Cage System
- K242391 — Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
- K242826 — ProLift Wedge Expandable Spacer System
- DEN240029 — Healgen Rapid Check COVID-19/Flu A&B Antigen Test
- K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
- K240843 — GENESIS (MS-P02-GEN)
- K240980 — EPIQ Series Diagnostic Ultrasound System
- K241029 — SpineUs System
- K242084 — EMPHASYS Acetabular Shell with RapiTite HA
- K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
- K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K242357 — Water Container (MAJ-901); Water Container (MAJ-902)
- K242375 — OR3O Dual Mobility System
- K242457 — EARP Interbody System
- K242693 — DEKA Infusion System, DEKA Administration Set
- K242746 — OvertureTi Knee Resurfacing SystemTM
- K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
- K240074 — Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)
- 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; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF
- 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 (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.