FDA 510(k) clearances — page 1449
clearances on record, most recent first.
Clearances — page 1449
144,801–144,900 of 175,890- K852622 — AEROSOL ONE
- K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT
- K854821 — MMG EXTERNAL FEMALE CATHETERS
- K860087 — SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM
- K860205 — BIO-PEN CALCULATOR
- K860335 — COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
- K860350 — SERUM CHOLINESTERASE REAGENT SET
- K860713 — LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
- K860715 — ALP (ALKALINE PHOSPHATASE) REAGENT
- K860716 — ENZYMATIC BUN REAGENT
- K860733 — CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
- K860965 — BETA QUIK STICK
- K861055 — EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
- K861057 — MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
- K861061 — EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
- K861141 — MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
- K861168 — CLEARBLUE PREGNANCY TESTING KIT
- K861194 — ULTROSPEC K KINETICS SPECTROPHOTOMETER
- K861204 — GLUCOSE OXIDASE PROCEDURE
- K861221 — EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
- K861311 — GLUCOSE (HEXOKINASE) REAGENT SET
- K861320 — MMS T4 RIA KIT
- K861328 — NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY
- K861413 — BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
- K845002 — CUDDLE HEART -AUDITORY/VIBRATION DEVICE
- K845003 — CUDDLE CARRIER - INFANT BED
- K845004 — CRIB CUDDLE - INFANT BED
- K854326 — NO FLOSS FLOSSER
- K854590 — HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
- K854591 — SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
- K854757 — 5000 SERIES ECG ELECTRODES
- K860015 — MODIFIED CHERNE CAD DETECTOR
- K860262 — TA-6C - PART NUMBER SLZ 7520
- K860273 — MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY
- K860368 — URDYN 5000 (UROFLOWMETER)
- K860429 — MEADOX SURGIMED GUIDE CATHETER
- K860546 — DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
- K860767 — MODEL E 600 ELECTROCARDIOGRAPH
- K860771 — VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE
- K860840 — GUIDED WIRE TORQUER
- K860842 — ANGIOJECT
- K860958 — CATHETER INTRODUCER
- K861009 — BIPOLAR CARDIAC PACEMAKER, MODEL 110
- K861030 — LABOR-DELIVERY STRETCH/BED
- K861045 — MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT
- K861110 — MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER
- K861113 — ER-7C CLINICAL PROBE MICROPHONE
- K861153 — DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
- K861174 — SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
- K861192 — GENTLE BACK, PLASTIC URINARY DRAINAGE BAG
- K861200 — UROTOPO CATHETER
- K861254 — MODEL ST HEARING AID
- K861298 — FISCH DRILL IRRIGATOR
- K861355 — WHENEVER UNSCENTED REGULAR THIN MAXI-PADS
- K861356 — WHENEVER UNSCENTED SUPER THIN MAXI-PADS
- K861357 — WHENEVER UNSCENTED PANTY SHIELD
- K854362 — MODIFIED BRAIN ATLAS III
- K854499 — GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR
- K854865 — PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
- K854953 — DIAMED MODELS 600, 900, 960, 964
- K855053 — THABEST-IGE
- K855221 — SERATEST RF (HEMAGGLUTINATION) KIT
- K860027 — FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY
- K860100 — MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
- K860694 — IV7200 AND IV7400 INFUSION PUMP
- K861015 — ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
- K861410 — LIC MOBILE TRANSPORT STRETCHERS
- K853089 — SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE
- K853889 — CORDIA CMV-M
- K860333 — MICRO-ELISA HLH TEST KIT MONOCLONAL
- K860334 — VISI-CHECK HLH TEST MONOCLONAL
- K860451 — MUREX (TM), SUDS (TM), HCG ASSAY
- K860543 — BLOOD UREA NITROGEN (BUN) TESTCARD
- K860557 — LATEX R. TYPHI
- K860639 — IONIZED CALCIUM AND BLOOD PH TESTCARDS
- K860726 — ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
- K860770 — AM-100 I/A AMPAC
- K860794 — WRAPPERS, SUNGLASSES
- K860891 — AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
- K861002 — VISION SGPT (ALT)
- K861094 — BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
- K861095 — BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
- K861301 — BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
- K852436 — AMBULASE
- K854355 — GREENLEAF SMART POLYGRAPH PROGRAM
- K854991 — REUMAGEN ASL
- K860162 — FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
- K860354 — SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
- K860632 — EBI HAND MASSAGING PUMP (HMP)
- K860821 — BIODEX SYSTEM
- K861016 — GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
- K861206 — NAUTILUS LEG EXTENSION TESTING & REHABILITATION
- K861218 — AQUA ARK, IMMERSION HYDROBATH
- K861289 — BASIC LIGHT
- K861312 — LYFO-KWIK (TM) COAGULASE PLASMA
- K861373 — HUMAN LUNG CARCINOMA CELLS (A549)
- K861383 — SOLEX THERAPEUTIC PAD
- K844772 — 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
- K853774 — EM ELECTRODE
- K854201 — OMRON DIGITAL BP MONITOR HEM-700CP
Data sourced from openFDA. This site is unofficial and independent of the FDA.