FDA 510(k) clearances — page 984
clearances on record, most recent first.
Clearances — page 984
98,301–98,400 of 175,890- K962073 — URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
- K962126 — ACS CKMB II IMMUNOASSAY
- K952880 — MODEL LP-1000 VOLUME VENTILATOR
- K954202 — PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
- K955010 — AUTOVAC BP SYSTE, 2000 SERIES
- K960369 — THYROID PEROXIDASE ANTIBODY ELISA
- K960370 — THYROGLOBULIN ANTIBODY ELISA
- K960401 — ULTIMATE SEAL
- K960619 — MORE-L INJECTOR KIT PLUS
- K962107 — IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5
- K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
- K961060 — ARISTO ESOPHAGEAL STETHOSCOPE
- K961100 — MICRO ANASTOMOSIS CLAMP
- K961121 — KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
- K961134 — BARD GRAFT SIZER
- K961170 — BREAST TREATMENT AID
- K961210 — SAM FACIAL IMPLANT
- K961234 — DEPUY ADVANTAGE FIXATION SCREW SYSTEM
- K961323 — LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
- K961563 — EC-384OTL, VIDEO COLONSCOPE
- K961870 — PLAYTEX SLIMFIT TAMPONS
- K950944 — AMBULATORY (HOLTER) RECORDING SYSTEM
- K955446 — CONMED VCARE RETRACTOR/ELEVATOR
- K955457 — DIGISCAN 2 PLUS
- K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
- K960634 — TITANIUM HEALING CAPS
- K960802 — CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
- K961155 — SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
- K961245 — HEARTPORT ENDOPULMONARY VENT
- K961270 — HEARTPORT ENDOSINUS CATHETER
- K961279 — SHARPLAN LASERS, INC. RUBY LASER SYSTEM
- K961375 — DIA SCREEN 10 WAY REAGENT STRIPS
- K961379 — DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)
- K961389 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
- K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
- K961456 — PLAYTEX TAMPONS #10296
- K961948 — SAS SALMONELLA O FACTOR 20 ANTISERUM
- K961949 — SAS SALMONELLA O FACTOR 14 ANTISERUM
- K961950 — SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
- K961951 — SAS SALMONELLA O FACTOR 6 ANTISERUM
- K961952 — SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
- K961953 — SAS SALMONELA H Z24 ANTISERUM
- K961954 — SAS SALMONELLA H Z35 ANTISERUM
- K961955 — SAS SALMONELLA H Z42 ANTISERUM
- K961956 — SAS SALMONELLA H G,M,Q ANTISERMU
- K961957 — SAS SALMONELLA H Z4, Z32 ANTISERUM
- K961958 — SAS SALMONELLA H Z4 COMPLEX ANTISERUM
- K961960 — SAS SALMONELLA H Z4, Z24 ANTISERUM
- K961961 — SAS SALMONELLA H F,G,T ANTISERUM
- K961962 — SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM
- K961963 — SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM
- K961964 — SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM
- K961966 — SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM
- K961967 — SAS SALMONELLA O POLY B ANTISERUM
- K950672 — IMMULITE CMV IGG
- K950838 — VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
- K954302 — VYGON PREMI-CATH - LONG TERM CATHETER
- K955342 — OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER
- K960092 — SERAQUEST TOXOPLASMA IGG
- K960167 — SYSTEM, THERMAL REGULATING 74-DWJ
- K960493 — SYPHILIS IGG HUMAN SERUM CONTROLS
- K960899 — IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW
- K961009 — STRESSWRITER EXERCISE TESTING SYSTEM
- K961055 — CT PROSPEED CT/I
- K961090 — AUTOMATIC VISUAL FIELD PLOTTER AP-125
- K961191 — COLISCREEN
- K961193 — FULL FRAME ZOOM SYSTEM
- K961208 — 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER
- K961242 — AMO PHACOFLEX II INTERSECTION SYSTEM
- K961510 — ACS FRT4 IMMUNOASSAY
- K953661 — FIRST CHOICE GLUCOSE URINE TEST STRIPS
- K953662 — FIRST CHOICE KETONES URINE TEST STRIPS
- K955662 — CANDELA Q-SWITCHED ALEXANDRITE LASERS
- K960531 — MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
- K960637 — 5MM ENDOSCOPE
- K960874 — COMPLEMENT CONTROL
- K960934 — HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
- K961078 — AUTOMATED VITRECTOMY DEVICE
- K961092 — VISART
- K961137 — ATI PLASMA PUMP (PP-04)
- K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM
- K961354 — QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
- K961355 — MULTICHECK
- K961435 — MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
- K961481 — ELECSYS 2010 ANALYZER
- K961890 — FOUNDATION 9MM FORGED CEMENTED STEM
- K962030 — KARL STORZ REMORGIDA FORCEPS
- K933722 — HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
- K942032 — PLAMP, PLAMP PLATE, PLAMP WITH HOOK
- K953411 — BREATH-TAKER BREATH-ALERT
- K953697 — THE IMS DPAP MASK, IMS MODEL NUMBER 82000
- K955087 — HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
- K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
- K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
- K960762 — SYNERGY PLUS
- K961213 — ALTA DOME AND PLUNGER (MEC HIP BOLT)
- K961406 — NEUROVIEW SCISSORS
- K961490 — ELECSYS T4 ASSAY
- K961620 — ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
- K961659 — CEDIA CORE TDM MULTI-CAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.