FDA 510(k) clearances — page 714
clearances on record, most recent first.
Clearances — page 714
71,301–71,400 of 176,637- K033335 — LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
- K033504 — GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
- K033567 — MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
- K033597 — ATR 5000, LC 5000, IMPLANT SYSTEM
- K030263 — IMMUNICON CELLTRACKS ANALYZER
- K031419 — GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
- K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
- K032713 — BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
- K032811 — CEDIA VANCOMYCIN ASSAY
- K032874 — HBA SPERM-HYALURONAN BINDING ASSAY
- K033492 — MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
- K033548 — ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
- K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
- K030644 — CONTEC DUO, CONTEC LC, CONTEC LCR
- K031842 — SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K031876 — ELECTRO FLO PERCUSSOR, MODEL 5000
- K032665 — OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
- K032849 — AERONEB GO NEBULIZER, MODEL AG-AG2000
- K032992 — UNIMARK HOME PREGNANCY TEST DEVICE
- K033022 — PROTEMP 3 GARANT
- K033041 — ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
- K033314 — PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
- K033441 — BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
- K033444 — PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER
- K033565 — LMT NOMAG IC 1,5
- K022750 — PLV CONTINUUM VENTILATOR, MODEL P1000
- K023452 — OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E
- K023537 — NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
- K023874 — SYSTEM 100 ULTRAFILTRATION CATHETER
- K030958 — ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
- K030978 — SCORPIO NRG KNEE SYSTEM
- K031375 — BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
- K031493 — GROWTH GUIDANCE PLATE
- K031676 — HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
- K032260 — ARAMIS II DERMATOLOGICAL LASER
- K032286 — CALCIGEN PSI BONE GRAFT SUBSTITUTE
- K032331 — DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
- K032379 — QUASAR, MODEL MD21
- K032613 — TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
- K032708 — PLASTALGIN AND PLASTALGIN ORTHO
- K032739 — UCR SPINAL SYSTEM
- K032787 — NEUROLASE, MODELS 150V, 150C, 1064
- K032895 — BI-ANGULAR SHOULDER SYSTEM
- K032907 — FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
- K032908 — FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K032935 — EPI-SCAN, MODEL P 100
- K032938 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER
- K032940 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
- K032995 — SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
- K033035 — TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
- K033057 — DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
- K033237 — VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
- K033401 — MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
- K033431 — LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
- K033438 — BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
- K033501 — MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
- K033502 — LIGHTSPEED 6.0 CT SCANNER SYSTEM
- K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
- K032802 — HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
- K032869 — COOK CODA BALLOON CATHETER
- K033187 — INTERLAB IMMUNOFIXATION TEST(S)
- K033188 — TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
- K033320 — SCOUT PRO
- K033345 — AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
- K033384 — THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
- K033443 — SPEEDLYSER INFUSION CATHETER KIT
- K033486 — GE PRECISION MPI
- K021478 — DELTA SHOULDER
- K031463 — MARINA MEDICAL SILICONE PESSARY
- K031541 — PARADIGMPAL, MODEL MMT-7330
- K031553 — SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
- K031666 — ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
- K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
- K032753 — GLUCOSE TOLERANCE BEVERAGE
- K032784 — ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
- K033119 — PASCO MIC AND MIC/ID PANELS
- K033350 — BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
- K033473 — MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
- K011261 — STONE EXTRACTOR BALLOON CATHETER
- K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES
- K024286 — GYRUS OPEN FORCEPS
- K032160 — ARTELON SURGICAL SUTURE
- K032539 — CYNOSURE PHOTOGENICA SV LASER
- K032586 — CAPROSYN ABSORBABLE SUTURE
- K032987 — ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
- K033115 — ORTHODEK
- K033134 — MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
- K022304 — ACCUMAP AUTOMATIC PERIMETER
- K030787 — SHILEY FLEXTRA TRACHEOSTOMY TUBE
- K030792 — BARD ENDOTRACHEAL TUBE, CUFFED
- K031007 — KWIKEZE MALE CONDOM APPLICATOR
- K031024 — MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
- K031175 — CLICK'X MONOAXIAL SCREWS AND HOOKS
- K031236 — AUTO-BAND LIGATOR
- K031380 — OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
- K031515 — SPIROPRO SPO2
- K031646 — BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
- K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
- K032094 — PASSMED SPINAL SYSTEM
- K032521 — BARD DUAL LUMEN URETERAL CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.