FDA 510(k) clearances — page 832
clearances on record, most recent first.
Clearances — page 832
83,101–83,200 of 175,890- K982101 — SHELHIGH NO-REACT DURA SHIELD
- K994380 — CEDIA DAU AMPHASSURE ASSAY
- K000506 — BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
- K000518 — MACROPRO GEL
- K000519 — GLUCANPRO
- K000682 — SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
- K000982 — A100 AESTHETIC DIODE LASER
- K001079 — RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
- K001085 — MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
- K001132 — BONE BIOPSY NEEDLE
- DEN000006 — EROS-CLITORAL THERAPY DEVICE (CTD)
- K000299 — DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
- K000357 — EZ CONNECT RESIN
- K000385 — OPTI-FREE EXPRESS LENS DROPS
- K000428 — DIXI 2
- K000445 — MEDTRONIC MODEL 7499 EXTENSION
- K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP
- K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
- K000667 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
- K000668 — POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA
- K000684 — SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
- K000689 — UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
- K000891 — STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
- K000954 — KERR GEL ETCHANT
- K001020 — 8100 VITAL SIGNS MONITOR
- K001047 — GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
- K001051 — RX EVEREST
- K001094 — SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
- K001136 — CORDIS INTRODUCER GUIDE
- K001216 — POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001270 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
- K001279 — GT990402 DIGITAL THERMOMETER
- K993149 — PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
- K993564 — POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
- K993619 — CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
- K993756 — HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
- K994372 — MODEL 120
- K000227 — UMBICUT
- K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
- K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP
- K000540 — POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
- K000701 — HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
- K000712 — PORTABLE INTENSIVE CARE UNIT, MODEL PIC
- K000832 — STEROTACTIC LOCALIZATION DEVICE (SLD)
- K000942 — CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
- K001006 — THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
- K001010 — ASCENT KNEE REVISION FEMORAL STEM
- K001015 — ELECSYS THYROGLOBULIN CALCHECK
- K001019 — TI500 GLOBE-TROTTER TRANSPORT SYSTEM
- K001048 — LIGHT BOND (QUICK CURE)
- K001138 — AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
- K994171 — MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
- K000096 — ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
- K000338 — VITAPORT 3
- K000361 — K-ASSAY AT-III
- K000920 — REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
- K991549 — EMBOSPHERE MICROSPHERES
- K993513 — DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
- K993630 — BIOLOK SCREW
- K000255 — COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
- K000649 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
- K000964 — STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
- K001021 — LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
- K001118 — MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
- K993410 — DATES-OHMEDA AESTIVA SMARTVENT MRI
- K994023 — HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
- K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
- K000392 — RESPONSE 2000 HIP STEM
- K000412 — VISION R/F TILTING TABLE
- K000432 — RESPONSE 2000 CEMENTED HIP STEM
- K000443 — REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
- K000452 — SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
- K000496 — EVERSHEARS BIPOLAR SCISSORS
- K000557 — MEDVIZER PACS, MODEL RELEASE 2000
- K000612 — ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
- K000985 — MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
- K001016 — GE LOGIQ 700
- K001105 — MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
- K001133 — VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
- K992597 — LORAD LT-100 LASER TREATMENT SYSTEM
- K000212 — KSEA CHARDONNES MORCELLATION KNIFE
- K000444 — MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
- K000507 — CAVERMAP SURGICAL AID
- K000867 — POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
- K000956 — MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
- K001123 — KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
- K001130 — 3D MANUAL COARSE MANIPULATOR MN-188NE
- K001131 — 3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
- K001189 — MODIFICATION TO CONVERTORS SURGICAL GOWNS
- K993492 — DEVILBISS NEBULIZER MODEL 800
- K993871 — BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
- K000195 — CRANIAL DRILL
- K000247 — BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
- K000448 — PACSSTATION
- K000549 — OPART, MODEL MRT-600
- K000650 — BETEL POWDER FREE LATEX EXAM GLOVES
- K000868 — NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
- K000875 — ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
- K000953 — DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
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