FDA 510(k) clearances — page 353
clearances on record, most recent first.
Clearances — page 353
35,201–35,300 of 176,542- K150995 — Electronic Pulse Stimulator
- K151197 — Lariat snare
- K151317 — Armada 18 PTA Catheter
- K151534 — HemosIL D-Dimer HS
- K140762 — AUTOMATIC BLOOD PRESSURE MONITOR
- K141965 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
- K143075 — ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
- K143236 — Theranos Herpes Simplex Virus-1 IgG Assay
- K143745 — Arthrex Corkscrew and SwiveLock Suture Anchors
- K150039 — MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
- K150296 — Biodenta Customized Abutment-Hybrid
- K150477 — 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
- K150670 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
- K150712 — LTM-Perforated Surgical Mesh
- K150750 — Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
- K150784 — Admira Fusion
- K150872 — BruxZir Anterior Milling Blanks
- K150935 — SpeediCath Compact Eve
- K150990 — ECVUE Mapping System
- K151170 — Tosama 100% Organic Cotton Menstrual Tampon
- K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
- K151548 — VersaOne Bladed Trocar, VersaOne Bladeless Trocar
- K142845 — SILKPRO laser hair removal system
- K143227 — Magellan Robotic System, Magellan Robotic Catheter 10Fr
- K143271 — CastleLoc-P Anterior Cervical Plate System
- K143688 — ASFORA ANTERIOR CERVICAL PLATE SYSTEM
- K150724 — SculpSure
- K150873 — CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
- K150889 — Suture Wires and Wire Loops
- K150901 — Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
- K151147 — STARband, STARlight
- K151478 — Wondfo CR3 Keyless Split Sample Cup
- K151497 — EN Snare Endovascular Snare System
- K141680 — AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws
- K142642 — Vitalograph Model 6600 Compact
- K143474 — Artemis Hand Held Imaging System
- K150167 — V60 Anesthetic Vaporizer
- K150320 — COMPASS
- K150445 — ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
- K150493 — Sensis
- K150574 — Modular Power Positioning System
- K150591 — Besmed Reusable Jet Nebulizer
- K151224 — Lineum OCT Spine System
- K151246 — Aneroid Sphygmomanometer
- K151281 — AGE Automatic Wrist Blood Pressure Monitor
- K151290 — Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
- K151331 — The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
- K151485 — GENESIS
- K142812 — Vitalograph Model 6800 Pneumotrac
- K143411 — TRAUS ENDO
- K143484 — BioZorb Marker
- K150327 — Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
- K150363 — NOVA Dental Implants System
- K150518 — Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
- K150925 — Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
- K151201 — Stryker ICONIX with Needles
- K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
- K151465 — AeroDR SYSTEM 2
- K141933 — FILAO NC RX PTCA DILATATION CATHETER
- K150494 — Proteus Digital Health Feedback Device
- K140820 — XENOMEM WOUND MATRIX
- K142750 — JiveX
- K143071 — Nacera Pearl
- K143398 — Plato MICROCATH 27B Microcatheter
- K143449 — ADH 200 Analyzer Software
- K143581 — Arrow Epidural Catheter Kit
- K150041 — CORA (Coagulation Resonance Analysis) System
- K150680 — Freedom Cementless Femoral Component
- K151116 — CapLOX II/TowerLOX Pedicle Screw System
- K133279 — MEDIHONEY WOUND DRESSINGS
- K141110 — CRYOCARE CS SURGICAL SYSTEM
- K142357 — DuraSheath Introducer Sheath System
- K142814 — Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
- K142830 — Ophthalmed Bending Laser Probes
- K143437 — Droplet Pen Needles
- K143505 — Zimmer Patient-Specific Abutment, Internal Hex, Titanium
- K143604 — Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
- K150538 — Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
- K150951 — aeris Balloon Dialation Catheter
- K150975 — Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors
- K151214 — ALIF Interfixated System
- K151398 — K-Pack II Needle - 29G x 5/16 Thin Wall
- K151509 — GSI TympStar Pro Middle Ear Analyzer
- K120577 — MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
- K133075 — Plus Surgical Gowns (EO Sterilized), PMGB-XXX
- K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX
- K143093 — 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
- K143110 — GALAXY MIS Screw System
- K150029 — Habib EUS RFA
- K150053 — STALIF C; STALIF C-Ti
- K150766 — Carestream DRX-1 System
- K151031 — Virage OCT Spinal Fixation System
- K151161 — VICTUS Femtosecond Laser Platform
- K151178 — VariAx 2 Wrist Fusion System
- K151387 — Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
- DEN140018 — ESOPHAGEAL COOLING DEVICE
- K142548 — MIDSLEEVE
- K142786 — Ontex Unscented Tampons with Colored Plastic Applicators
- K142834 — DiscoverEEG System, Model DE-401
- K142912 — Merits Yoga Power Scooter, S542
Data sourced from openFDA. This site is unofficial and independent of the FDA.