FDA 510(k) clearances — page 758
clearances on record, most recent first.
Clearances — page 758
75,701–75,800 of 176,637- K022092 — SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
- K022146 — SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
- K022767 — RAICHEM LIPID CALIBRATOR
- K020607 — SLEEPFLO, MODEL 101501
- K021083 — VERACAM
- K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- K021265 — DATEX-OHMEDA HMEF 500
- K021355 — ENDOSSEOUS IMPLANT
- K021493 — ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
- K021781 — EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
- K021837 — BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
- K022543 — ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
- K022563 — HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
- K022564 — INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
- K022590 — PVP (POLYVINYLPYRROLIDONE)
- K022591 — RANDOX LIPID CONTROL
- K022795 — MODIFICATION TO THE MAESTRO SYSTEM
- K013197 — WS-501 HEAT LAMP
- K013756 — ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
- K020360 — ABR-2000
- K021080 — NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
- K021807 — GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
- K021916 — HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
- K021988 — MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
- K022031 — NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
- K022032 — ACETAL
- K022063 — SAFEPRO SAFETY SYRINGE
- K022206 — JENSEN GOLD FOIL
- K022260 — FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
- K022568 — PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
- K022569 — PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
- K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
- K013003 — APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
- K013869 — SR IVOCRON
- K020320 — RADIOSYSTEM/NT, MODEL 80-13020
- K020550 — PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
- K020785 — INTROCAN SAFETY IV CATHETER
- K021804 — PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM
- K021834 — SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
- K022030 — POLY-CARB
- K022157 — RF TENT
- K022191 — MODIFICATION TO TENOR SPINAL SYSTEM
- K022334 — HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
- K022352 — HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
- K022443 — SPERMASSIST
- K022547 — ACIDIFIED TYRODES SOLUTION
- K022556 — REFLECTION MODIFIED ACETABULAR SHELLS
- K022718 — VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
- K022764 — 7F LAUNCHER GUIDE CATHETER
- K022790 — THE AUTOTAC SYSTEM TITANIUM TACK
- K011879 — 3A DENTAL IMPLANT SYSTEM
- K020057 — PALMLIGHT
- K021398 — APL IGA ELISA KIT
- K021759 — 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
- K021760 — NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
- K022290 — PROTEIN S AC
- K022491 — LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
- K022510 — FONIX, MODEL 7000
- K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
- K022623 — 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
- K022704 — TAILWIND
- K020529 — LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
- K021737 — REPHRESH VAGINAL GEL
- K021777 — GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
- K021782 — BNF
- K021786 — TITANIUM ANKLE ARTHRODESIS NAIL
- K021791 — VERTE-STACK SPINAL SYSTEM
- K021933 — TEMPFIX EXTERNAL FIXATION SYSTEM
- K021947 — CERANUM 87
- K022330 — ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
- K022481 — S2 TIBIAL NAIL
- K022511 — AART CALF IMPLANT
- K022530 — POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
- K022531 — 2MM PEDIATRIC FLEX NAIL
- K022555 — ACCOLADE C FEMORAL STEMS
- K022601 — POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
- K022711 — MODIFICATION TO AVALON CUP SYSTEM
- K013305 — ENOXAPARIN TEST CARD
- K020220 — ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
- K020400 — DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
- K020768 — 3T VESSEL CANNULAS
- K021062 — CHITO-SEAL
- K021762 — BCLEAR
- K021819 — ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
- K021986 — BRAINET
- K021996 — BOLTON PTA CATHETER
- K022044 — SURGISIS STAPLE LINE REINFORCEMENT
- K022072 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
- K022239 — SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
- K022332 — LITE MINERAL OIL
- K022335 — ALLGRAD AND ALLGRAD100
- K022350 — BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
- K022437 — UNI KNEE
- K022487 — MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
- K022488 — MODEL OBC-63 BREAST ARRAY COIL
- K022507 — DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
- K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
- K022554 — MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
- K022561 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K022578 — ENDIUS FLEXTIP BLADE
Data sourced from openFDA. This site is unofficial and independent of the FDA.