FDA 510(k) clearances — page 870
clearances on record, most recent first.
Clearances — page 870
86,901–87,000 of 176,637- K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY
- K990649 — GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
- K990761 — TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE
- K990843 — SERUM CROSSLAPS ONE STEP ELISA
- K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
- K991450 — ETCHING GEL
- K991554 — GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K991602 — EPTFE RINGED GORE-TEX VASCULAR GRAFT
- K991605 — CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION
- K991624 — POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
- K991774 — ACRON MC MODIFICATION
- K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- K991808 — OPTIBOND SOLO PLUS 2
- K983764 — VIEWPOINT TOOLS- STERRAD
- K984033 — ATLAS MONITOR
- K990234 — QUALISYS PSA IMMUNOASSAY
- K990355 — STAINLESS STEEL SOFT SUTURE WIRE
- K991211 — EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
- K991225 — MTI 1 ML SYRINGE
- K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
- K991238 — FCI CRAWFORD PROBE INTUBATION SETS
- K991263 — THERMOPLATE
- K991337 — SPERM MAINTENANCE MEDIUM WITH GLYCEROL
- K991341 — ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
- K991342 — PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
- K991572 — ISOLUX SURGICAL HEADLIGHT
- K991590 — C-LEG (3C100)
- K991807 — TITANIUM LOW PROFILE SCREWS
- K992155 — VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7
- K984090 — SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)
- K990818 — RAPIDONE - MARIJUANA TEST
- K991479 — VISER PENILE TUMESCENCE MONITOR
- K991711 — BISTITE II SC
- K991787 — N LATEX IGE MONO REAGENT
- K991849 — NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC
- K991852 — OCUSYSTEM ART ADVANTAGE, MODEL 995
- K992054 — ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
- K981938 — TAMPA HYPERBARIC MONOPLACE CHAMBER
- K982180 — DURAGEN DURAL GRAFT MATRIX
- K983518 — LIFESTYLES XTRA PLEASURE
- K991323 — SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
- K991434 — QUADRATURE WRIST COIL, MODEL 445PH-64
- K991468 — IMMERGE IMAGE CORRELATION
- K991537 — SAMSUNG RAYPAX SYSTEM
- K991955 — MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
- K992068 — STATUS STIK, ACCUSIGN STIK
- K992105 — IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
- K982974 — DD URETERAL STENT, INTEGRAL STENT
- K983768 — MODIFICATION TO GAMMA GUIDANCE SYSTEM
- K991170 — RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
- K991420 — MODIFIED HAM'S F-10 WITH ALBUMIN
- K991421 — FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)
- K991626 — WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
- K983631 — AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
- K983837 — HEDROCEL ACETABULAR CAGE SYSTEM
- K984640 — THERMAL ANGEL
- K990454 — BIO-INTERFERENCE SCREW
- K990496 — ANESFLOW-DUAL DRIP IV INFUSION SET
- K990602 — RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
- K990965 — SYNTHES CERVIFIX SYSTEM
- K991122 — CRYO-MONO CRYOGRNIC SYSTEM
- K991169 — SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
- K991176 — OPUS TROPONIN I CALIBRATOR
- K991177 — OPUS TROPONIN I (CTN) TEST MODULES
- K991212 — MODIFICATION TO TRUZONE PEAK FLOW METER
- K991275 — WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
- K991457 — DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
- K991539 — EXCELL 22
- K991821 — NITRILE EXAMINATION GLOVE, POWDERED, BLUE
- K991939 — BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
- K991953 — MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
- K992058 — BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
- K990461 — MCKINLEY SP DISPOSABLE INFUSION PUMP
- K991098 — DIFOTI SYSTEM
- K991242 — GLUCOMETER ELITE TEST STRIPS
- K991282 — COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
- K991576 — ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE
- K991663 — AST/SGOT
- K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
- K992033 — MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
- K984586 — FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
- K990198 — AMIB7
- K990628 — GYRUS ENDOUROLOGY SYSTEM
- K991107 — SHADOW TRAYS
- K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS
- K991229 — K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
- K991287 — SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
- K991314 — COAGULOOP
- K991405 — OMNI-FIX, HUMERAL NAIL
- K991593 — ORIBRUSH - STANDARD - B002
- K991595 — ORIBRUSH - WITH PROTECTIVE TIP - B001
- K991603 — GRIT BLASTED HUMERAL STEM
- K991780 — FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C
- K991781 — FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
- K991952 — OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
- K992010 — W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)
- K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
- K990057 — SYNERGY ADJUSTABLE LENGTH ROD
- K990280 — BIONIKE AQ BARBITURATE TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.