FDA 510(k) clearances — page 869
clearances on record, most recent first.
Clearances — page 869
86,801–86,900 of 175,890- K982853 — SILK SUTURE
- K983036 — SINGLE AXLE TOTAL ELBOW
- K983610 — CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
- K984031 — SPIROVIT, MODEL SP-250
- K984194 — HP M2376A DEVICE LINK SYSTEM
- K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
- K990360 — AU6
- K990523 — B2C, ESPACE REVISION CUP SYSTEM
- K990528 — ORTHOPHOS 3/3 CEPH/3 DS
- K990631 — CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
- K991032 — GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
- K991223 — ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
- K982418 — BUECHEL-PAPPAS MODULAR SALVAGE STEM
- K983435 — ROTORBLADE
- K984171 — ENDOPEARL
- K984332 — SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,
- K984527 — IN TOUCH DIABETES MANAGEMENT SOFTWARE
- K990139 — KENSTONE
- K990303 — EBI OMEGA 21 SYSTEM
- K990356 — THE BAGNOLI-8 EMG SYSTEM
- K990452 — ORLIGHT 2000 SURGICAL LASER SYSTEM
- K990596 — DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
- K990622 — BOLD SCREW
- K990632 — OPTICAL TRACKING SYSTEM (OTS)
- K990776 — AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
- K990804 — STAYFUSE
- K990821 — PROVIDENCE CUP SYSTEM
- K990866 — QUINTON MEDTRACK CR PLUS TREADMILL
- K990906 — FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
- K991092 — EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
- K991135 — SOFT TISSUE SUTURE WASHER
- K991152 — HI-TORQUE BALANCE TREK GUIDE WIRE
- K991161 — HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
- K983512 — WATER TREATMENT SYSTEM FOR HEMODIALYSIS
- K983680 — TRINITY II SINGLE CHAMBER DVT PUMP
- K984151 — STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
- K984223 — BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
- K984540 — KERAVISION VACUUM RING SYSTEM
- K990333 — MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
- K990624 — AUTOSTAT II ANTI-SM/RNP ELISA
- K990625 — AUTOSTAT II ANTI-SM ELISA
- K990626 — AUTOSTAT II ANTI-SS-B/LA ELISA
- K990627 — AUTOSTAT II ANTI-SS-A/RO ELISA
- K990782 — DAUM NEUROGATE TROCAR
- K990796 — AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
- K990797 — AUTOSTAT II ANTI-SCL-70 ELISA
- K990798 — AUTOSTAT II ANTI-JO-1 ELISA
- K991095 — QUICKCARD HCG COMBO TEST, MODEL #9014
- K991411 — GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
- K983711 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K990422 — RENU MULTIPLUS MULTI-PURPOSE SOLUTION
- K990468 — LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
- K990511 — X-TIP INTRAOSSEOUS PERFORATOR
- K990547 — PILLING WECK SURGICAL Y STENT FORCEPS
- K990610 — ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
- K990870 — REDI-TEST THC
- K990947 — MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY
- K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
- K991067 — MODIFICATION OF: DAVIDSTRIP HCG
- K991277 — MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
- K983588 — SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
- K983776 — EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
- K990327 — RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
- K990384 — EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
- K991151 — VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
- K991197 — VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24
- K981311 — COWBOY XV
- K983451 — CHALLENGE TEST PACK
- K983579 — SYNTHETIC SERUM SUBSTITUTE (SSS)
- K990425 — SIDEKICK INFUSION KIT
- K990427 — ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
- K990459 — EBI VUECATH ENDOSCOPIC SYSTEN
- K990485 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
- K990486 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
- K990526 — KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K990527 — KLEENHANDS POWDERED LATEX EXAMINATION GLOVES
- K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
- K990982 — CAVIT LC
- K991029 — RAPIDFLAP CRANIAL CLAMP
- K991044 — DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)
- K991097 — PBN DRAINAGE CATHETER GUIDEWIRES
- K991138 — LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
- K991294 — MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
- K990214 — FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
- K990312 — AVIA PAIN MEDICATION DELIVERY SYSTEM
- K990722 — ETEST FOR CEFUROXIME
- K991027 — BI-DIRECTIONAL TUNNELER
- K991195 — CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
- K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
- K983456 — ENSITE 3000 SYSTEM
- K983732 — THORAX FD AND MULTIX FD
- K984156 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
- K984436 — PVS BASICS
- K990175 — SHEATHES (NON-LATEX), STERILE
- K990206 — SERIM BLOOD LEAK TEST STRIP
- K990367 — PDQ AND PDQ-TI ABUTMENT
- K990371 — DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
- K990757 — CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA
- K990775 — URETERAL ACCESS SHEATH SET
- K990858 — LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
Data sourced from openFDA. This site is unofficial and independent of the FDA.