FDA 510(k) clearances — page 447
clearances on record, most recent first.
Clearances — page 447
44,601–44,700 of 175,770- K111274 — JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
- K111480 — MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
- K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
- K120656 — EVEREST SPINAL SYSTEM
- K120667 — VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
- K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
- K120686 — ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
- K111636 — REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
- K113115 — EPICARE YAG
- K113144 — PAGEWRITER TC 20, 30, 50, 70
- K113361 — SECURIS SPINAL FIXATION
- K113371 — STAPHYLOCOCCUS QUICKFISH BC
- K113759 — AVAIRA (ENFILCON A) CONTACT LENS
- K120065 — PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
- K120069 — MEDLINE STOPCOCK AND MANIFOLD
- K120204 — REPROCESSED FEMORAL COMPRESSION DEVICE
- K120238 — RTVUE XR OCT
- K120670 — HAMILTON-T1
- K120694 — ENCORE 26 ADVANTAGE KIT
- K111695 — HYBRID GRAFT
- K112247 — A BAER WITH ABAER I/O FUNCTION
- K112426 — XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
- K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
- K113829 — ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE
- K120190 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
- K120330 — PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
- K120433 — CLEAR + BRILLIANT LASER SYSTEM
- K120696 — TIGER SPINE SYSTEM
- K120735 — PATHASSIT LIGHT SEEKER
- K120802 — ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
- DEN110002 — SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
- K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
- K110019 — RESPIRATORY HUMIDIFER
- K111058 — URETRON MODEL URT
- K111549 — ATTUNE SLEEP APNEA SYSTEM
- K111664 — DIAZYME CYSTATIN C POC TEST KIT
- K112119 — CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
- K112351 — ULTRA BEAUTY
- K112452 — ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
- K113168 — DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
- K113431 — CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
- K120145 — SIMPLE T NASAL MASK
- K120213 — ETCH-RITE SUPREME
- K120221 — GE ECHOPAC
- K120273 — KITTYCAT CATHETER, KITTYCAT 2 CATHETER
- K120378 — PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
- K120379 — PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
- K120563 — KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
- K120799 — ARISURE NEUTRAL VALVE
- K110737 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
- K111703 — INFRARED EAR THEROMETER
- K112538 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
- K112702 — IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
- K112798 — LOCKING COMPRESSION PLATE SYSTEM
- K112863 — ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN
- K113058 — TIGER SPINE SYSTEM
- K113233 — POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
- K113288 — VPAP ST-A
- K113327 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
- K113365 — INFANT ARRAY
- K120005 — ACDS
- K120088 — MCOMPASS ANORECTAL MANOMETRY SYSTEM
- K120206 — MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
- K120568 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
- K120578 — ACCOLADE II HIP STEM
- K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
- K120627 — TOSHIBA 1.5T QD HEAD COIL
- K120738 — FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
- K120893 — IMAGER II ANGIOGRAPHIC CATHETERS
- K103035 — SMARTPILOT VIEW MODEL MK04500
- K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
- K110690 — ONE PERSONAL LUBRICANT (SILICONE)
- K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
- K112307 — RESIGLASS PASTE
- K112422 — CRAG LATERAL FLOW ASSAY (LFA)
- K112774 — BD RECYKLEEN SHARPS COLLECTORS
- K112834 — MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
- K112948 — JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
- K112950 — JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
- K113243 — EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
- K113324 — REXIOUS HOOK FIXATION SYSTEMS
- K113547 — GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
- K113695 — ELLIPSE PRECICE TRAUMA NAIL SYSTEM
- K113702 — FOTONA XP ND: YAG LASER SYSTEM
- K120123 — AQUASHIELD CO2 SYSTEM
- K120576 — ZAVATION IBF SYSTEM
- K120630 — AZUR DETACHABLE 18
- K111558 — SURGICASE GUIDE
- K112755 — ABACUS 5
- K112977 — MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
- K113247 — ANESTHESIA INJECTION TOOL SET
- K113369 — ZIMMER PERSONA KNEE SYSTEM
- K113672 — PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
- K113815 — RESSCAN
- K120061 — WOUND PROTECTOR
- K120096 — MULTIFIX P KNOTLESS FIXATION DEVICE
- K120101 — INDEPENDENCE SPACER
- K120416 — INSULATION TESTER
- K120484 — VISIA ONCOLOGY
- K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
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