FDA 510(k) clearances — page 875
clearances on record, most recent first.
Clearances — page 875
87,401–87,500 of 176,637- K990894 — ETB TROCAR SYSTEM
- K991010 — ACP
- K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE)
- K991182 — MODIFICATION OF N/T PROTEIN CONTROL SL
- K991364 — MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
- K991387 — ELAN ALKALINE PHOSPHATE REAGENT KIT
- K991429 — DIAMOND II VALVE
- K991460 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
- K991583 — NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
- K982925 — LAMINOSS DENTAL IMPLANT
- K984022 — PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
- K990493 — INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE
- K990509 — OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
- K990672 — LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
- K990936 — THE VAULT
- K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING
- K990964 — SIGNADRESS DUODERM DRESSING
- K991324 — TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
- K991394 — STAPES PROSTHESES
- K991589 — FLEXIBLE VASCULAR CLAMP, VERSION 2
- K983216 — CVS PERSONAL LUBRICANT
- K983665 — MANOMETRIC ASSEMBLIES
- K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
- K984052 — SYNERGY IOM SYSTEM
- K984229 — LATEX EXAMINATION GLOVES (POWDERED)
- K990381 — TOTALBOND
- K990474 — ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
- K990585 — INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
- K990586 — CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
- K990652 — INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
- K990665 — BQ/BM INTEGRATED LASER DELIVERY SYSTEM
- K990669 — MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
- K990699 — ORTHO-GLOW GLITTER
- K990716 — GALLINI BYCUT NEEDLE
- K990840 — NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
- K990841 — NUGARD NITRIL NITRILE EXAMINATION GLOVE
- K990848 — TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
- K990879 — PRE POWDERED LATEX EXAMINATION GLOVES
- K990935 — JACKSON ESOPHAGEAL DILATOR
- K991030 — PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
- K991172 — IONOSIT BOND
- K991461 — OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
- K991627 — WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
- K983715 — THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K983875 — VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
- K984537 — KERATOME SYSTEM, MODEL K3000
- K990561 — OPTICAL FORCEPS
- K990566 — TAS ANALYZER, MODEL 1009
- K990568 — SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
- K990620 — EXCELART
- K990650 — CONSEAL F
- K990693 — FLEXNEEDLE PLUS
- K991048 — ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2
- K991224 — K-ASSAY CRP
- K991298 — BONE MULCH SCREW SYSTEM
- K991404 — PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)
- K991459 — COPALIS EBV-M ANTIBODY ASSAY
- K991550 — FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS
- K982226 — UROMED BRACHYTHERAPHY IODINE-125 SOURCES
- K983575 — ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
- K983728 — LORENZ IMF SCREW
- K984104 — ITI DENTAL IMPLANT SYSTEM
- K984486 — PULSEMASTER DENTAL LASER SYSTEM
- K990087 — DMD DIGITAL X-RAY SYSTEM
- K990479 — HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR
- K990482 — 3M CLINPRO PROPHY PASTE, MODEL 12611
- K990515 — MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
- K990696 — OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE
- K990698 — OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
- K990729 — FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
- K991094 — IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
- K991096 — IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
- K991129 — HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
- K991258 — NOVUS VERDI DELIVERY SYSTEMS
- K991278 — PHILIPS TOMOSCAN AV-NT
- K991363 — 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
- K991484 — AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
- K991501 — ACCLAIM INFUSION PUMP
- K984241 — ROCS ULTRASEED
- K990426 — CALCIUM SCORING
- K990441 — INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
- K990447 — 1000 PRESSURE INFUSION SIGMACON 1000
- K990455 — PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
- K972803 — TRACER O-T-W MAPPING DEVICE
- K984269 — DBEST OCCULT BLOOD TEST KIT
- K990011 — CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
- K990073 — CALCITONIN
- K990093 — ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
- K990411 — MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
- K990442 — ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
- K990550 — 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
- K990774 — ABBOTT ARCHITECT CEA
- K990957 — ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
- K991070 — COULTER Z2 ANALYZER
- K991136 — B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
- K991210 — K-ASSAY CRP CALIBRATOR SET
- K991252 — AIA-PACK FT3 ASSAY
- K983408 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K984098 — ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
- K990480 — OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
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