FDA 510(k) clearances — page 401
clearances on record, most recent first.
Clearances — page 401
40,001–40,100 of 175,770- K131647 — TRINITY ACETABULAR SYSTEM
- K131656 — MORCELLEX SIGMA GENERATOR
- K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
- K132030 — MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
- K132252 — EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
- K132369 — MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
- K132630 — WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
- K132659 — VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
- K132696 — TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
- K132713 — NMI COAXIAL MICROINTRODUCER SET
- K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
- K122370 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
- K124043 — LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
- K130150 — TCM MASSAGER
- K130275 — QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
- K130952 — PRECISION ONE LIFECARE; DETECTO; DETECTO
- K130983 — GENII ARC SMART ARGON PROBE
- K131388 — TRANSCEND HEATED HUMIDIFIER
- K131411 — COSEAL
- K131431 — AIRO CT SYSTEM
- K131795 — NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
- K131885 — SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
- K132068 — PHILIPS DXL 12/16-LEAD ECG ALGORITHM
- K132084 — PROTURA COUCH SOFTWARE
- K132092 — ESTEYA
- K132133 — CG+ ARROW JACC POWERED BY ARROW VPS STYLET
- K132278 — COCHLEAR BAHA 4 SOUND PROCESSOR
- K132654 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K132700 — PERIMETER INTERBODY FUSION DEVICE
- K132701 — PRIMI SUPPORT CATHETER
- K132777 — NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
- K121790 — ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- K130455 — 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
- K130510 — ARTHREX COMPRESSION PLATES
- K131289 — I-GEN
- K131440 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
- K131751 — FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
- K131873 — NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
- K131891 — ECLIPSE TREATMENT PLANNING SYSTEM
- K131965 — XVI R5.0
- K131992 — MULTICHEM P
- K132287 — JAZZ SYSTEM
- K132665 — PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC
- K123402 — DIAGNOCAM
- K130654 — CRYSTAL ULTRA
- K131529 — SHENGGUANG MANUAL WHEELCHAIR
- K131685 — GE ECHOPAC
- K131773 — BRILLIANCE ICT
- K131937 — VOLUSON I/E
- K132171 — AIXPLORER
- K132274 — AIXPLORER
- K130172 — BELIMED STEAM STERILIZER MST-V
- K130177 — ANATOMIC PEEK CERVICAL FUSION SYSTEM
- K130365 — X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
- K131429 — RELIANCE CERVICAL IBF SYSTEM
- K131526 — SFI-BAR
- K131888 — T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
- K132046 — PIPELINE KNEE SYSTEM
- K132069 — DESARA MESH, DESARA BLUE
- K132508 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K132672 — EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
- K132692 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K131177 — SINUFLUSH LAVAGE SYSTEM
- K131622 — MROZ REVERSE OSMOSIS SYSTEM
- K131723 — COROENT SINGLE TAB SYSTEM
- K132091 — MULTICHEM IA AND IA PLUS
- K132174 — MULTICHEM WBT
- K132203 — PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
- K132317 — MICROPLEX COIL SYSTEM (MCS), VFC
- K132391 — IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
- K122143 — VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
- K124024 — APD LUER-LOCK ADAPTER
- K130021 — PHILIPS HERCEPTEST DIGITAL SCORE
- K130053 — BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
- K130810 — ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
- K131354 — RENOVIS BIPOLAR HIP SYSTEM
- K131375 — AUTOLAP SYSTEM
- K131903 — EQUINOX CO2 LASER
- K132420 — WINGMAN EXTENDABLE TIP SUPPORT CATHETER
- K132479 — OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
- K132513 — Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
- K132626 — PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
- K132632 — TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
- K132644 — LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
- K122311 — GC-3000E DIGITAL COLPOSCOPE
- K124025 — ALPHA-PRO WHITE VARNISH
- K130373 — NAVIOS FLOW CYTOMETER SYSTEM
- K130840 — SMARTBUILDER SYSTEM (SB1)
- K131122 — S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
- K131394 — TRANSTEK GLASS BODY FAT ANALYZER
- K132314 — MEDLINE ANTI-REFLUX VALVE
- K113738 — CREODENT SOLIDEX CUSTOM ABUTMENT
- K121817 — VCARE A
- K122711 — FACIAL SPA
- K123130 — ANSWATCH WRIST MONITOR MODEL TS-0411
- K130232 — ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
- K130595 — ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
- K131114 — DIGITAL FLAT PANEL X-RAY DETECTOR
- K131161 — EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
- K131745 — BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
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