FDA 510(k) clearances — page 514
clearances on record, most recent first.
Clearances — page 514
51,301–51,400 of 176,542- K094018 — LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
- K100127 — ELI 230 ELECTROCARDIOGRAPH
- K100135 — GDS-DC12
- K100173 — IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT
- K100241 — CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
- K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
- K090744 — CLARO
- K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD
- K092472 — NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
- K093611 — VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002
- K093836 — ELECSYS TSH CALCHECK 5
- K093922 — INOMAX DS
- K093991 — SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
- K100005 — BD PEN NEEDLE
- K100116 — LASERTOUCHONE (OTC)
- K100191 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
- K100394 — MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
- K100745 — LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
- K090301 — BINAXNOW PBP2A TEST, MODEL 890-000
- K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM
- K093746 — VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
- K093904 — GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
- K093907 — WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
- K100104 — HYBERNITE RAINOUT CONTROL SYSTEM
- K100108 — AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
- K100272 — INTELLIVUE CLINICAL INFORMATION PORTFOLIO
- K100362 — CAMBRIDGE HEART OEM
- K100747 — CONTREX PLUS LOW CONTROL SOLUTION
- K100881 — SYNAPSE OBLIQUUS MIP/MPR/FUSION
- K092521 — ZUMA-C
- K093554 — RETROFLEX DILATOR KIT
- K093695 — PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
- K093697 — VASHE WOUND THERAPY SOLUTION
- K100145 — A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06
- K100392 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K090975 — DEROYAL NON-LOCKING BONE FIXATION SYSTEM
- K091022 — MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
- K092066 — PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE
- K100081 — ENTEROSCOPY OVERTUBE, MODEL 00712140
- K100084 — MULTI FRAME WHEELCHAIR
- K100111 — NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
- K100384 — FIBERLASE C02 LASER WAVEGUIDE
- K100737 — MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
- K100892 — RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
- K091720 — SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM
- K092335 — PEAK EXPIRATORY FLOW METER, KN-9710
- K093802 — ULTRAVIEW DM3 MONITOR
- K093932 — ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
- K100252 — MASTER-VU A-SCAN, MV4500
- K100264 — T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060
- K100284 — LIQUIBAND ULTIMA, LUT 003
- K100683 — NEUROLINK IP MODEL: PK1117
- K091772 — POWDER-FREE VINYL EXAM GLOVES
- K092348 — POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
- K092351 — POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
- K093229 — CATHETER CONNECTIONS DUALCAP
- K093288 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
- K093394 — BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
- K093680 — DIAZYME CYSTATIN C ASSAY
- K093806 — MYKNEE CUTTING BLOCKS
- K094007 — UNICEM
- K100046 — M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
- K100250 — XCERAM
- K100335 — ORS VISUAL
- K100417 — XKNIFE 5
- K100676 — SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
- K100701 — SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
- K090845 — APEX ARC HIP STEM
- K091791 — PROVANT SYSTEM, MODEL 4201
- K092765 — LANX ANTERIOR PLATING SYSTEM
- K092984 — PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
- K093243 — COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
- K093279 — NAVIX ACCESS DEVICE
- K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
- K093845 — ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
- K094041 — ALPHA ORTHOPAEDICS AT3 SYSTEM
- K100215 — ARCHIMED REMEDY CERVICAL PLATE
- K100224 — ESTECH COBRA BIPOLSR II
- K100597 — HARMONIC FOCUS SHEARS
- K100662 — FEMVUE CORNUAL BALLOON CATHETER
- K091770 — VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR
- K093176 — MED-LOK
- K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR
- K100419 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K100673 — EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
- K100692 — DIGITAL SPOT MAMMOGRAPHY SYSTEM
- K083312 — MINIHIP STEM
- K090036 — SYSTEM 1.5 STERILE PROCESSING SYSTEM
- K092387 — MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
- K092578 — LIFEGLOBAL PROTEIN SUPPLEMENT
- K093341 — CENTURY MODEL 105C
- K093371 — MODEL DGH 6000 SCANMATE A
- K093632 — INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
- K093790 — SIMONDR DRP
- K093935 — SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
- K100023 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
- K100164 — MR INSPIRE WITH EXTENDED KIT
- K100599 — CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
- K100670 — S-SCAN, MODEL 9800020010
- K083785 — VITALA CONTINENCE CONTROL DEVICE
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