FDA 510(k) clearances — page 881
clearances on record, most recent first.
Clearances — page 881
88,001–88,100 of 176,637- K990049 — CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000
- K990192 — BIOPSY-DIGIT
- K990369 — SYNERGY CEMENTED HIP STEM
- K990430 — ULTRACISION HARMONIC SCALPEL HAND PIECE
- K990531 — VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
- K982173 — BUZBEE
- K982992 — ZOLL M SERIES SPO2 OPTION
- K983171 — CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
- K983927 — GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
- K984418 — UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
- K990240 — ELECTROGLOTTOGRAPH
- K990506 — MABIS NB-02 ULTRASONIC NEBULIZER
- K990573 — ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
- K981996 — TITANIUM FEMORAL COMPONENT
- K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
- K981446 — WAKO AUTOKIT LP(A)
- K982283 — WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
- K983379 — GTI-PF4 ELISA
- K984271 — MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
- K984491 — SYSTEM U3 FOR CEFUROXIME
- K984581 — SYSTEM U3 FOR CEPHALOTHIN
- K984608 — GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K990108 — LC FLOWFILL
- K990282 — ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
- K990283 — BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K990375 — DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
- K990453 — NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
- K990514 — MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
- K990576 — OSOM CARD PREGNANCY TEST, MODEL 103
- K990578 — OSOM CARD II HCG-URINE TEST, MODEL 102
- K983105 — CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01
- K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
- K984394 — ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
- K990035 — RF
- K990498 — OPTIBOND SOLO PLUS
- K980351 — BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
- K981702 — AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
- K982952 — IMFAST
- K983164 — RESTORE (AKA RE/STOR)
- K983194 — SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
- K984382 — ACCU GUIDE
- K984424 — AURA DYE LASER SYSTEM (ADLS)
- K984443 — ORBSCAN
- K984552 — COOL-TIP RF SYSTEM
- K984602 — SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
- K984607 — PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX
- K984623 — MAXIM REMOVABLE MOLDED POLY TIBIA
- K990156 — MULTITAK SS BUTTONS
- K990295 — BONE ANCHOR SYSTEM III (BAS III)
- K990366 — EXMOOR SUCTION CLEARANCE KIT
- K981812 — EBV-VCA IGG ELISA TEST SYSTEM
- K982980 — LIGHTSHEER LONG PULSE RUBY LASER
- K982996 — POLYMER OBL SB ANCHOR / SUTURE COMBINATION
- K983071 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
- K983671 — NATURAL BRAND ACUPUNCTURE NEEDLES
- K984017 — ALLISON MEDICAL INSULIN SYRINGE (AMIS)
- K984352 — AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR
- K984357 — TRANSFX EXTERNAL FIXATION SYSTEM
- K984502 — NERVE BLOCK INFUSION KIT
- K984596 — VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
- K990315 — MONOPAQUE
- K990326 — OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
- K990379 — MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
- K981431 — PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
- K981542 — PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
- K981947 — STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)
- K983075 — GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
- K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
- K984371 — MEPITEL NON ADHERENT SILICONE DRESSING
- K984388 — HA ABSORBENT WOUND DRESSING
- K990242 — TOPOGRAPHIC IMAGING MARKER
- K990298 — TOPOGRAPHIC IMAGING MARKER
- K990306 — HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
- K964235 — ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
- K982668 — PHORESOR II,MODEL PM900
- K984322 — DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
- K984364 — SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820
- K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV
- K990131 — PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
- K990490 — SSA-320A JUST VISION 200/ SSA-325A JUST VISION
- K982098 — TUTODROP 1 AND TUTODROP 2
- K982738 — VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
- K983318 — FIXATION SYSTEM
- K983476 — BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
- K983790 — VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
- K983817 — BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
- K984287 — PROVISIONAL DENTAL IMPLANT SYSTEM
- K984306 — `THE INSEMINATOR' (PROPOSED)
- K984370 — HYPERGEL 20% HYPERTONIC SALINE GEL
- K984490 — SUTURELESS ANCHOR
- K984539 — FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
- K984543 — SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
- K984550 — PRE-THREADED ENDOBUTTON
- K984593 — MODIFICATION OF CUTINOVA THIN DRESSING
- K984595 — MODIFICATION OF CUTINOVA HYDRO DRESSING
- K984597 — MODIFICATION OF CUTINOVA CAVITY DRESSING
- K984599 — MODIFICATION OF CUTINOVA FOAM DRESSING
- K990136 — ANATOMICA GLENOID COMPONENT
- K990182 — D-SIGN V (R&D PROJECT DW267#17)
- K990235 — D-SIGN VI (R&D PROJECT DW266#9)
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