FDA 510(k) clearances — page 360
clearances on record, most recent first.
Clearances — page 360
35,901–36,000 of 175,770- K142939 — Revolution Spinal Fixation System
- K142948 — BIOSURE REGENESORB interference Screw
- K142952 — InMode Diolaze Device
- K143393 — Triathlon Tritanium Cone Augments
- K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone
- K143624 — Headless Compression Screw System
- K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K142641 — Intelliwave4
- K142914 — DacryoCATH
- K143223 — CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT
- K143522 — Presto Inflation Device
- K143588 — Surefire Infusion System 021
- K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
- K140046 — SPINOUS PROCESS FUSION (SPF) PLATE
- K141114 — BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
- K141132 — ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
- K141253 — NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
- K141398 — PASS LP SPINAL SYSTEM
- K141441 — MENNTOR X7
- K141465 — CARDIOGARD EMBOLI PROTECTION CANNULA
- K141622 — ILLUMINATED MEDIASTINOSCOPE
- K141783 — TDX SP2 POWER WHEECHAIR
- K142059 — FOX MOBILE
- K142363 — NUSTAT, NUSTAT XR
- K142366 — Puritan OptiTranz Liquid Stuart Collection and Transport System
- K142554 — Revolution Full Face Mask
- K142635 — Medline Silicone Foley Catheter
- K142890 — Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.