FDA 510(k) clearances — page 368
clearances on record, most recent first.
Clearances — page 368
36,701–36,800 of 176,542- K142974 — Extension Sets
- K143189 — t:flex Insulin Delivery System
- K143225 — INFX-8000V with Wireless Footswitch
- K143334 — Range/Denali/Mesa Spinal System
- K143594 — VaPro Pocket
- K133187 — FREERIDER FR1, models FR1-13, FR1-15, FR1-17
- K133412 — S200, S300
- K140237 — DISPOSABLE NEBULIZER SET
- K140671 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
- K141588 — NUTRA STIM HAIR LASER COMB
- K141596 — NUTRA STIM HAIR LASER COMB
- K141857 — CrossTie Intraosseous Fixation System
- K142034 — 3M STERI-VAC STERILIZER/AERATOR
- K142075 — BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
- K142136 — ACCUCATH MIDLINE CATHETER SYSTEM
- K142152 — CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM
- K142297 — Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
- K142350 — PK J-HOOK
- K142529 — Genesis Reusable Rigid Container System
- K142539 — EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
- K142712 — Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
- K142946 — TIVA
- K143022 — BioHorizons Tapered Internal Implants
- K143220 — SIDEKICK EZ FRAME External Fixation System
- K143481 — IntellaMap Orion High Resolution Mapping Catheter
- K143483 — MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
- K143757 — ANUTRA Feedback Aspiration Syringe
- K140359 — MAXIMIS SPINAL FIXATION SYSTEM
- K141275 — ENDOPHYS PRESSURE SENSING SHEATH KIT
- K141515 — AED HYSTEROSCOPE AND ACCESSORIES
- K141615 — ENDOPHYS BLOOD PRESSURE MONITOR
- K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
- K141861 — HILTHERA 4.0
- K142256 — Applied BioPhotonics Phototherapy System ABPT1003
- K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
- K142667 — Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm
- K142840 — Unity Network ID
- K143107 — DLP Vein Graft Cannula
- K143486 — Ufi Gel hard C
- K140587 — MR-CT VVA
- K140722 — INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
- K141852 — IFS ADVANCED FEMTOSECOND LASER SYSTEM
- K141923 — INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
- K142316 — IMPAX Agility
- K142850 — McKesson Radiology Mammography Plus
- K140264 — MADM
- K142233 — zenostar MO, Zenostar T, Zenostar VisualiZr
- K142710 — S9 Portable Digital Color Doppler Ultrasound System
- K143149 — Arsenal Spinal Fixation System
- K140893 — CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
- K133088 — ZX-27
- K141186 — FIREBIRD SPINAL FIXATION SYSTEM
- K141851 — NAVILAS LASER SYSTEM
- K142229 — Laparoscopic FMsealer
- K143154 — IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
- K143472 — TE7 Diagnostic Ultrasound System
- K133333 — UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
- K142124 — AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
- K142289 — PK Spatula
- K142611 — TYRX Neuro Absorbable Antibacterial Envelope
- K142699 — LITe Plate System
- K143175 — AEx Generator; PlasmaBlade T
- K141586 — OWL CANNULAE
- K141695 — ACROSSPINE PEDICLE SCREW SYSTEM
- K141868 — TRIA FANP
- K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
- K143188 — 3.Omm Biomet Cannulated Screw System
- K140649 — VECTRIX EXTERNAL FIXATOR
- K141936 — MICROBLAB, MICROLOOP
- K142746 — G7 Finned Acetabular Shell
- K143378 — AQUARIUS Gastrostomy Replacement Tube
- K141046 — MIDI-SRS
- K141878 — HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
- K142407 — Straight Stud Attachment
- K142429 — CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
- K143352 — IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
- K140387 — Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
- K140436 — ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
- K141479 — KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
- K141920 — Wrist Hemiarthroplasty System
- K142151 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K142326 — HP Tissue Matrix
- K142328 — nvc
- K142427 — TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
- K142502 — ALIANS ULNA LOCKING PLATING SYSTEM
- K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
- K142630 — Instru-Safe Instrument Protection System
- K142697 — NExCT 7
- K142933 — Biomet Tibial trays
- K143197 — Nice1
- K143376 — ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material
- K143407 — Klassic HD Hip System
- K130447 — SPEEDY FLAP SYSTEM
- K140977 — EVOTECH ECR
- K140989 — POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)
- K141721 — BOVINE PERICARDIUM PATCH
- K142373 — Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
- K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
- K142528 — AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm
- K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System
Data sourced from openFDA. This site is unofficial and independent of the FDA.