FDA 510(k) clearances — page 724
clearances on record, most recent first.
Clearances — page 724
72,301–72,400 of 176,637- K031204 — DENTAPORT ZX
- K031677 — SYNTHES (USA) CALVICLE HOOK PLATE
- K031735 — CENTURION SES EPIKERATOME
- K031749 — BODYGUARD INFUSION SYSTEM
- K031771 — SHIMADZU COLLIMATOR R-30H
- K031885 — NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
- K031907 — NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551
- K031954 — COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
- K031994 — LINVATEC 300W XENON LIGHT SOURCE
- K032057 — TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
- K032090 — NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
- K032209 — NOMOS CORVUS 5.0M
- K032217 — 14G CORMARK BIOPSY SITE IDENTIFIER
- K032252 — MODEL 120 SERIES MATERNAL/FETAL MONITOR
- K032282 — MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
- K032285 — OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
- K032295 — GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
- K032301 — NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
- K032347 — BIOMARC TISSUE MARKER
- K032377 — ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
- K032396 — RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
- K032429 — QSC-127 SHOULDER ARRAY COIL SET
- K032452 — MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230
- K032490 — TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
- K032504 — ARTHROCARE SYSTEM
- K023884 — MODIFICATION ORIA SPINAL SYSTEM
- K023902 — SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
- K030192 — DUET SYSTEM
- K030281 — CRYOTRON 2 CRYOTHERAPY DEVICE
- K030357 — QUANTIX/OR DEVICE
- K030490 — ISM1+, IMS2+, AND UTM+
- K030957 — PERFECT CAPSULE
- K031420 — S & C -BRACKET ADHESIVES
- K031551 — NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
- K031698 — ELECYS SHBG CALCHECK
- K031852 — SAPPHIRE DETACHABLE FIBER COILS
- K031990 — ELECSYS PRECICONTROL TROPONIN T
- K032132 — TISSUELINK FLOATING BALL MODEL 23-201-1
- K032191 — OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
- K032198 — AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
- K032204 — MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
- K032207 — COBRA COOLED SURGICAL PROBE, MODEL M004159670
- K032225 — EP-WORKMATE WITH RPM SYSTEM
- K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT
- K030222 — NX SYSTEM
- K030407 — ADVISOR, MODEL 9200
- K031047 — MIRAGE VISTA MASK
- K031427 — ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
- K031433 — SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
- K031489 — PITANGA
- K031566 — SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
- K031584 — SIROTORQUE L
- K031917 — MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
- K032010 — GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
- K032011 — GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
- K032077 — CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
- K032259 — PASCO MIC AND MIC/ID PANELS
- K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
- K032375 — VAXCEL PORT, MODELS 45-336 AND 45-338
- K030429 — STERRAD 200 STERILIZER
- K030479 — JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
- K030730 — FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
- K031742 — BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
- K032063 — PEM 2400 PET SCANNER
- K032131 — BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS
- K032287 — MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
- K023140 — VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
- K030843 — VPAP III
- K031157 — POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
- K031958 — MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
- K032168 — GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
- K032369 — MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
- K032372 — NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
- K013643 — AUSAM TOTAL ALBUMIN ASSAY
- K021560 — MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K023014 — VIANOX DELIVERY SYSTEM, MODEL I
- K031674 — MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM
- K031814 — STATCO2METER, MODEL 10-55372
- K031816 — DVNET MDV-PACS
- K031836 — PHILIPS FRESCO RELEASE 1
- K031866 — MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
- K031957 — MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
- K032080 — ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
- K032158 — XIVE DENTAL IMPLANT SYSTEM MULTIPLE
- K032172 — DISPOSABLE POWDER FREE VINYL EXAM GLOVES
- K032190 — DISPOSABLE POWDERED VINYL EXAM GLOVES
- K032284 — XIVE TG DENTAL IMPLANT SYSTEM
- K032401 — ORTHOVIEW
- K021981 — IVENT 201 PORTABLE VENTILATOR
- K031442 — PBN GUIDEWIRES
- K031600 — CONDUCTION CATHETER
- K031616 — IUR FLUID MANAGEMENT SYSTEM
- K031651 — MODIFICATION TO CERASORB ORTHO
- K031865 — VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
- K032000 — COULTER LH 500 HEMATOLOGY ANALYZER
- K032073 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K032121 — MODIFICATION TO E-SCAN XQ
- K032246 — MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
- K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
- K032370 — CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
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