FDA 510(k) clearances — page 848
clearances on record, most recent first.
Clearances — page 848
84,701–84,800 of 175,890- K993013 — SURE BOND
- K993249 — OPC LOW WEAR OPAQUE PORCELAIN
- K993481 — K-ASSAY C4
- K993721 — UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
- K993646 — S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K981914 — TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
- K990659 — NASAL AIRE
- K990727 — SYNEFLASH & SYNEVIEW
- K990808 — PBN DILATORS
- K991105 — ECG ELECTRODE (VARIOUS)
- K991850 — SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
- K992665 — MACRA LP(A) ENZYME IMMUNOASSAY KIT
- K992842 — HICHEM ISE ELECTROLYTE REFERENCE
- K992844 — HICHEM ISE ELECTROLYTE BUFFER
- K992929 — DASH 3000 PATIENT MONITOR
- K992965 — CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
- K993014 — MODIFICATION TO DOCUMENT THYROID CAL.VER
- K993023 — SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
- K993126 — CD-CHEX CD 34
- K993425 — PRIMUS
- K993473 — SYNCHRON SYSTEMS DRUG CALIBRATOR 2
- K993589 — VARELISA RNP ANTIBODIES
- K993606 — K-ASSAY APO A1/B CALIBRATOR SET
- K993719 — KAC-300 KNEE ARRAY COIL
- K993728 — MEDRAD ENVISION CT INJECTOR SYSTEM
- K993740 — MAMEX
- K993763 — QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
- K993765 — QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
- K993780 — QSC-300 SHOULDER ARRAY COILS
- K981786 — IGA MININEPH ANTISERUM
- K991417 — ABL 735 ANALYZER
- K992257 — NEW MULTIPLES REAGENT STRIPS
- K992264 — OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
- K992449 — AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
- K992682 — MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
- K992683 — MODUS 2.5 MANDIBULAR TRAUMA SET
- K992710 — ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
- K992834 — GEM PREMIER 3000
- K992872 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
- K992894 — MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
- K992900 — PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
- K992909 — HYTAC
- K992996 — ENABLE ENDOSCOPIC BIPOLAR SCISSORS
- K993071 — PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
- K993252 — METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
- K993360 — PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
- K993437 — K-ASSAY C3
- K993441 — K-ASSAY ALPHA-1 AG
- K993444 — K-ASSAY ALPHA-1 AT
- K993480 — K-ASSAY HAPTOGLOBIN
- K993495 — POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
- K993502 — POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
- K993617 — DIGITRAKPLUS HOLTER RECORDER
- K993618 — DXP1000 HOLTER RECORDER
- K993637 — N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
- K993648 — ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
- K993791 — CT PERFUSION OPTION
- K993792 — SMART VESSEL ANALYSIS (SMART VA) OPTION
- K972383 — EASY-JET DEVICE
- K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007
- K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
- K991473 — SIRSCAN
- K991906 — LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
- K992235 — ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
- K992330 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K992341 — CIDEX OPA SOLUTION TEST STRIP
- K992538 — AMORPHOUS DIAMOND COATED SCREW
- K992890 — ROCHE COBAS INTEGRA OPIATES 300/2000
- K992920 — EBI SPINELINK SYSTEM
- K992925 — AX WORKSTATION DR-VIEWER SOFTWARE OPTION
- K992994 — TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
- K993119 — STERILE HYDROGEL
- K993128 — HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
- K993213 — K-ASSAY IGA
- K993273 — N LATEX FERRITIN
- K993286 — PIONEER SILICOAT STERNAL CABLE
- K993313 — COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
- K993349 — NIL, SURGEON'S GLOVE - POWDER FREE
- K993722 — BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
- K993723 — CARDIASURE CARDIAC MARKERS CONTROL
- K993725 — GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
- K992125 — XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
- K992239 — PILLAR CHIN IMPLANT
- K992240 — PILLAR MALAR IMPLANT
- K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
- K992829 — CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
- K992852 — SUTURE CLINCH
- K992887 — STAK-CHEX PLUS RETICS
- K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
- K993501 — 3D1 MICROPOSITIONING HEADSTAGE
- K993540 — ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
- K993666 — DISETRONIC PEN P100
- K990292 — I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
- K990537 — OSTEO-PIN MEMBRANE FIXATION PIN
- K992832 — SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
- K992848 — ALARMVIEW SYSTEM
- K992881 — HI BOND NON-PRECIOUS CERAMIC ALLOY
- K992885 — VERSALOK LOW BACK FIXATION SYSTEM
- K992919 — OXY-GLIDE ROOT CANAL CLEANSER & LUB.
- K992952 — LORENZ DISTRACTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.