FDA 510(k) clearances — page 873
clearances on record, most recent first.
Clearances — page 873
87,201–87,300 of 176,637- K991102 — COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
- K991106 — P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
- K991183 — DORNIER LASERTRODE FIBER
- K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071
- K991301 — CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
- K991409 — K-ASSAY RHEUMATOID FACTOR
- K991410 — 3402 HANDHELD PULSE OXIMETER
- K991600 — SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
- K991604 — EPI-FOAM SILICONE SHEETING
- K991611 — GE LOGIQ 500
- K991619 — FOUNTAIN Infusion Catheter and Occluding Guide Wire
- K991734 — MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
- K991795 — IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
- K991796 — IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
- K991797 — IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
- K983511 — SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
- K983629 — RPM RESPIRATORY GATING SYSTEM
- K983713 — PRODIMED MICROINJECTION PIPETTES
- K983987 — AMIGO MODEL 590000
- K984562 — VIVOSONIC
- K990795 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES
- K990801 — MINIMED 508 INSULIN PUMP
- K990833 — DOSE CALC, MODEL VS. 1.02
- K990913 — HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
- K991115 — LINEAR SHOULDER COIL, MODEL 414GE-09
- K991163 — VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
- K991288 — DISTENDER SERIES II BAROSTAT
- K991553 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
- K991643 — IDS4 V3.2 IMAGE DISPLAY SYSTEM
- K982961 — MEDIPOINT
- K983984 — COOLTOUCH V ND:YAG
- K990814 — CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
- K990869 — LEICA AT550
- K990966 — MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS
- K991773 — HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
- K973844 — GASTRIC AND RECTAL CATHETERS
- K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT
- K983296 — AUTO SUTURE ABBI SYSTEM
- K983308 — RC CORNET, MODEL #44F50
- K984374 — SURGISORB
- K990202 — SUGITA TITANIUM ANEURYSM CLIP
- K990743 — SOLO ORTHO
- K991202 — MODIFICATION TO WOUN'DRES
- K991660 — COPALIS MULTIPLEX EBV ANTIBODY ASSAY
- K981860 — A P HARNESS
- K983996 — SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
- K984035 — XK-95 HIGH SPEED MOTOR DRILL SYSTEM
- K984600 — METRA PS PROCEDURE KIT
- K990431 — AIA-PACK CA 125
- K990469 — LAMITRODE LEADS
- K990483 — RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
- K990668 — POWDER FREE BLUE NITRILE GLOVE
- K990728 — THERMAL CAUTERY DEVICE, FORCEPS
- K990778 — INSIGHT MILLENNIUM
- K990815 — COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
- K990889 — AUTODOSE INFUSION SYSTEM
- K990910 — MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
- K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET
- K990958 — ORTHOGONAL EP CATHETERS
- K991069 — KSEA NEURO-FIBERSCOPE
- K991167 — STERIS SMOKE EVACUATION SYSTEM
- K991442 — LC MICROFILL
- K991482 — UNI-CLIP STAPLE
- K991511 — POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
- K991538 — OPERA CUPFLANGED ACETABULAR COMPONENTS
- K991578 — SMARTSPOT 2000
- K991680 — SOFTINJECT
- K991710 — SSA-370A/POWERVISION 6000
- K982646 — AILEE SUTURES AND AILEE NEEDLES
- K990221 — INTRACOIL PERIPHERAL STENT
- K990658 — THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
- K990717 — FIXION INTRAMEDULLARY NAILING SYSTEM
- K990922 — OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
- K991236 — GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,
- K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
- K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
- K991552 — SYNTHES PEDIATRIC ROD SYSTEM
- K981353 — AVOGEL
- K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
- K984290 — IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
- K984468 — VITAL PEP
- K990154 — KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
- K990321 — ALPHAMED GEMINI SENSOR, SNORING SENSOR
- K990351 — BONE SCREWS
- K990353 — STAINLESS STEEL FIXATION PINS
- K990850 — COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
- K990943 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
- K991051 — KSEA EPIDUROSCOPE
- K991101 — COAG-A-MATE MAX
- K991123 — PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
- K991181 — MODIFICATION OF N PROTEIN STANDARD SL
- K991226 — FOUNDATION POROUS HIP STEM
- K991227 — 8MM FORGED CEMENTED STEM
- K991302 — SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
- K991372 — CRP
- K991641 — AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
- K991688 — WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
- K991707 — MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
- K991813 — UNI-GRAFT K DV VASCULAR GRAFT
- K974342 — ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
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