FDA 510(k) clearances — page 372
clearances on record, most recent first.
Clearances — page 372
37,101–37,200 of 176,542- K141792 — GENESIS TOUCH SYSTEM
- K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
- K142065 — TURNPIKE CATHETER
- K142118 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE
- K142203 — Atricure Cryo Module System; cryoICE cryoablation probe
- K142270 — LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
- K142272 — SNaP Wound Care System
- K142299 — CoRoent Small Interlock System
- K142367 — Hospira Primary Sets
- K142389 — Variolink Esthetic
- K142393 — PREDICATE III GUIDEWIRE
- K142394 — Masimo Root Monitoring System and Accesories
- K142424 — DR300 HOLTER MONITOR
- K142461 — VASCU-GUARD Peripheral Vascular Patch
- K142863 — Univers Rivers Shoulder Prosthesis System
- K143054 — Sherpa Pak Kidney Transport System
- K143074 — Sherpa Pak Cardiac Transport System
- K133766 — HUMICARE D900
- K140566 — SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE
- K140573 — WOUNDCLOT HEMOSTATIC GAUZE
- K140716 — OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
- K141682 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
- K141939 — TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET
- K141940 — CONCHASMART COLUMN
- K141952 — ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
- K142072 — GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
- K142098 — SIGNA PET/MR
- K142147 — EEVA SYSTEM
- K142238 — MAYFIELD Skull Clamp
- K142290 — KangLi pedical screw spinal system
- K142403 — Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
- K142467 — IntelAir Nasal Airway Support System
- K142496 — Collagen Dental Membrane - Conformable IIBP
- K142802 — Atlas SPEEDER Head/Neck
- K142045 — XPERT FLU/RSV XC ASSAY
- K133348 — STIM PROBE
- K133362 — SGS DENTAL IMPLANT
- K133674 — PHILIPS IQON SPECTRAL CT
- K133997 — LG SMARTHEALTH
- K134006 — DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
- K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
- K141872 — SUDOSCAN
- K142183 — GLIDESHEATH SLENDER
- K142197 — ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
- K142434 — ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
- K142525 — PK Lap Loop
- K142668 — Lesion-Loc Iodine I-125 Seed/Needle
- K142681 — ZEUS (ZIO ECG Utilization Service) System
- K142868 — 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin
- K143026 — Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
- K143106 — VEGA Knee System
- K143261 — 2.3MP Color LCD Monitor, RadiForce MX242W
- K141896 — COROENT SYSTEM
- K142012 — FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
- K142023 — LUNA INTERBODY SYSTEM
- K142062 — SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
- K142100 — AIXPLORER
- K142303 — NeumoFilt Ergo/Neumo Filt BiteOn
- K142520 — Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
- K142585 — PhaLinx Hammertoe System
- K142978 — Audit MicroControls Linearity LQ Special Diabetes
- K143027 — Xario 200, V3.0
- K143038 — Gel-Block 10X embolization pledgets
- K143234 — MaxZero Administration Sets
- K133303 — PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
- K140497 — ECVUE MAPPING SYSTEM
- K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
- K140910 — CENTERCROSS CATHETER
- K141194 — FM-3000 FETAL MONITOR
- K141263 — TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
- K141462 — VARIA-NCI
- K141640 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
- K141755 — ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K141774 — ZOLL X SERIES
- K141794 — ENDO-MARYLAND DISSECTOR
- K141811 — MORTARA MONITORING WAVEFORM VIEWER
- K141977 — MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL
- K142185 — EXPEDIUM VERSE SPINE SYSTEM
- K142251 — AVS AS PEEK Spacer
- K142399 — DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
- K142499 — Reline System
- K142510 — UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
- K142600 — VIAL-MATE Adaptor
- K142999 — EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable
- K143046 — Xario 100, V3.0
- K143047 — Arthrex iBalance Patella Implant, Dome
- K130019 — J-SCREW COMPRESSION SCREW
- K131973 — UNEXEF-38G ULTRASOUND SYSTEM
- K140085 — UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
- K140923 — TRACTION POLYPECTOMY SNARE
- K141345 — AEQUALIS FX2
- K141390 — INTERMITTENT PNEUMATIC COMPRESSION DEVICE
- K141844 — RESCAN 700, CALLISTO EYE
- K141958 — ERB ENDORECTAL BALLOON
- K142060 — TRANSOM ANTERIOR CERVICAL PLATE
- K142243 — LessRay with Tracking
- K142347 — Amedica Valeo II Interbody Fusion Device
- K142587 — Vertical Expandable Prosthetic Titanium Rib
- K142673 — Bio-Medicus Adult Cannulae and Introducer
- K143098 — 3MP Color LCD monitor, RadiForce RS340
Data sourced from openFDA. This site is unofficial and independent of the FDA.