FDA 510(k) clearances — page 868
clearances on record, most recent first.
Clearances — page 868
86,701–86,800 of 175,890- 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
- K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
- K990684 — MODIFICATION OF SAS SERUM/URINE HCG
- K990741 — SAS ONE-STEP PREGNANCY
- K991075 — ATLAST GLUCOSE CONTROL SOLUTION
- K991369 — ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
- K982451 — TTCGHI-T AND TTCTN3-T-T
- K983039 — EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF
- K990507 — ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER
- K990678 — PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
- K990756 — FLOW LINE
- K991436 — STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION
- K991134 — ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
- K972774 — GAS PLASMA STERILIZATION
- K983154 — CYSTIC DUCT BALLOON DILATING CATHETER
- K983393 — LIFEPAK 500 BIPHASIC
- K983691 — SCANFLEX SOLID COUPLANT MEMBRANE
- K984161 — CTS-310(B)
- K984189 — ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
- K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
- K990383 — APOLLO 5, APOLLO 10
- K990701 — OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
- K991085 — BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES
- K991194 — MODIFICATION TO ULTRA-SELECT GUIDEWIRE
- K991249 — FALCON IVF FOUR WELL PLATE
- K991251 — FALCON IVF ONE WELL DISH
- K991253 — FALCON IVF ROUND DISH
- K983982 — SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
- K984249 — SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
- K990328 — DBC, DONG BANG ACUPUNCTURE NEEDLES
- K990344 — ORALGIENE TONGUE CLEANER
- K990575 — TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
- K990577 — TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
- K990686 — POWDER FREE LATEX EXAMINATION GLOVES
- K990695 — OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
- K990702 — OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM
- K990748 — EDGE SYSTEMS STERILE TUBING
- K990812 — POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA
- K990829 — ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
- K990901 — POWDER FREE LATEX EXAMINATION GLOVES
- K990946 — BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES
- K991043 — LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
- K991193 — SAS HCG-CHECK
- K983475 — HEMOCHRON RESPONSE
- K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
- K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
- K990704 — ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
- K982340 — EXTRACORPOREAL BLOOD CIRCUIT
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