FDA 510(k) clearances — page 757
clearances on record, most recent first.
Clearances — page 757
75,601–75,700 of 175,825- K021748 — ENDIUS ATAVI SYSTEM
- K021799 — CEMENTED FEMORAL HEAD RESURFING DEVICE
- K021832 — ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
- K021879 — CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
- K021880 — CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
- K014166 — UHI-3 HIGH FLOW INSUFFLATION UNIT
- K020296 — ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
- K020985 — MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
- K020987 — BMN I TYPE MARROW ASPIRATION NEEDLE
- K021012 — LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
- K021030 — TITANIUM CANNULATED INTERFERENCE SCREW
- K021241 — SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
- K021922 — MODIFICATION TO PARA 5X
- K021930 — MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
- K012623 — REPROCESSED EXTERNAL FIXATION DEVICE
- K012634 — REPROCESSED EXTERNAL FIXATION DEVICE
- K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES
- K012648 — REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
- K013309 — GLUCOPRO EVO INFUSION PUMP
- K013593 — CARDEON AEGIS CATHETER
- K014009 — TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE
- K014018 — CHOLESTEROL 1, 2, 3
- K020205 — CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
- K020666 — DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
- K020996 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
- K021144 — SUBDURAL STRIP ELECTRODE
- K021912 — M2376 DEVICELINK SYSTEM
- K021924 — MEDICA EASYQC HEMATOCRIT CONTROL
- K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING
- K020378 — QUPID PLUS E.R.
- K020958 — CANDELA CBEAM PULSED DYE LASER SYSTEM
- K020980 — DIMENSION TPSA CALIBRATOR, MODEL #RC459
- K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
- K021683 — CINESCAN S
- K021701 — SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
- K021706 — HORIZONS HOT BIOPSY FORCEPS
- K021714 — RT-PLUS PE INSERT CLAMP
- K021729 — MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K021787 — VISUCAM
- K013962 — EQUATION FIXATION SYSTEM
- K020279 — FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
- K020539 — TIPOWER POWERDRIVE AND RIMPOWER X & SX
- K020639 — TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
- K020967 — TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
- K020999 — MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
- K021008 — ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
- K021184 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
- K021613 — NIVEOUS LIQUID DAM
- K021627 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K021695 — EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
- K021721 — EQUALIZER BALLOON CATHETER
- K010156 — SLEEP PAT 200 DEVICE
- K011592 — OXYGEN TREATMENT HOOD
- K013896 — SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA
- K020329 — DEVILBISS PD1000
- K020560 — WORKBENCH BY <GENX>
- K020941 — PALOMAR LUXG HANDPIECE
- K020959 — GLO-SPEC I, II AND III
- K021017 — LEESPEC DISPOSABLE VAGINAL SPECULUM
- K021089 — OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
- K021298 — ELEMENTS DIAGNOSTIC UNIT
- K021567 — STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
- K021640 — HANSATOME EXCELLUS MICROKERATOME
- K021811 — UNIDRIVE II PLUS DISPOSABLE TUBING SET
- K021861 — REMSTAR PRO WITH C-FLEX CPAP SYSTEM
- K021886 — OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
- K011676 — VIVAWAVE MICROWAVE SYSTEM
- K020335 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
- K021009 — OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
- K021019 — COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
- K021066 — MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
- K021100 — 300 PV COMPLETE ELECTROTHERAPY SYSTEM
- K021449 — CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
- K021680 — INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
- K020891 — NAKAO SNARE II AND NAKAO SNARE III
- K021016 — AMX-4 PLUS MOBILE X-RAY SYSTEM
- K021081 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
- K021181 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
- K021252 — BLOOD-PRESSURE METER
- K021423 — INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
- K021823 — CARDIOSPECT D90/CARDIO CAM
- K013297 — AIRCAST, MODEL #3011
- K013977 — ECHO-SCREEN T, TA, TD, TDA, TC
- K014113 — ENDOMAP
- K020857 — EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
- K020896 — OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
- K020907 — NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
- K020915 — SOPRO LIGHT SOURCES AND ACCESSORIES
- K021441 — RADIUS SNARE
- K021484 — HEMOGLOBIN A1C CONTROL
- K021586 — SECURE RELINE/PICKUP MATERIAL
- K021605 — MEDGEM
- K021866 — KARMA 800 SERIES MANUAL WHEELCHAIR
- K013022 — SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
- K020588 — X-IMAGE DIGITAL X-RAY SYSTEM
- K020603 — CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
- K020630 — ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
- K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100
- K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100
- K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200
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