FDA 510(k) clearances — page 964
clearances on record, most recent first.
Clearances — page 964
96,301–96,400 of 175,890- K963596 — POLAR CARE 300
- K963621 — STETHOS
- K963709 — CEMENT-ON FEMORAL STEM
- K963736 — SOFT DENTURE REBASING RESIN
- K963811 — CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
- K964035 — PHONAK MICROLINK, PERSONAL FM RECEIVER
- K964121 — WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
- K964476 — DE ORO 77
- K960970 — POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P
- K963320 — TFX MEDICAL GUIDEWIRE
- K963493 — FERRITIN CALIBRATOR
- K964578 — FIBREKOR
- K962172 — FLEXIBLE MINI-FIBERSCOPES
- K963170 — OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
- K963341 — MIDSTREAM ONESTEP PREGNANCY HOME TEST
- K963517 — SPECTRA SCIENCE BIOPSY FORCEPS
- K963547 — THE WRAP IMMOBILIZATION SYSTEM
- K963705 — COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A
- K963862 — TOUCH N' HEAT
- K963906 — PATIENT RESTRAINTS
- K964211 — DAVOL PLUME FILTER (5541420)
- K964477 — OZARK 40
- K953233 — SIMVIEW 3000 CT OPTION
- K953591 — CEP 8 SPECTRUMORANGE DNA PROBE KIT
- K962112 — NEW COMFORT CONTACT LENS CARE ACCESSORY
- K962760 — ENZYMUN-TEST FT3
- K962911 — CONTACT LENS WITH COLOR ADDITIVE
- K962952 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
- K963011 — LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
- K963135 — GIARDIA CELISA
- K963693 — OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
- K963724 — GAUZE SPONGE, NON X-RAY DETECTABLE
- K963753 — NASP TRANSPARENT DRESSING
- K963763 — EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
- K963902 — QUANTITATIVE FIBRINOGEN ASSAY
- K963964 — AVL COMPACT 3 PH/BLOOD GAS ANALYZER
- K963992 — CAPILLARY ADAPTOR ACCESSORY
- K964269 — PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
- K964588 — WATERS 515 HPLC PUMP (515)
- K960856 — KONSTRUCT PATELLAR COMPONENT
- K962061 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
- K962116 — GALILEO ENDOSCOPES
- K962195 — HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3
- K962217 — GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
- K962481 — QUASAR RECOVERY IMAGING PACKAGE
- K962537 — INCARE HOT/ICE LITE MACHINE
- K962569 — BIOMID BONE MARROW BIOPSY NEEDLE
- K962570 — ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
- K962984 — ISOLA PEDIATRIC COMPONENTS
- K963020 — GLOVEL GX
- K963029 — KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
- K963429 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
- K963486 — REVISION HIP SYSTEM
- K963487 — DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
- K963598 — INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS
- K963603 — DERMAGRAN HYDROPHILIC OINTMENT
- K963610 — AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES
- K963655 — CD HORIZON ANTERIOR SPINAL SYSTEM
- K963694 — EASYLYTE CALCIUM/CHLORIDE ANALYZER
- K963697 — ADVANCED DIAGNOSTIC VIEWER (ADV)
- K963714 — GRAND MEDICAL SUTURE REMOVAL KIT
- K963715 — DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
- K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
- K963720 — TRACHEOSTOMY KIT
- K963721 — SKIN SCRUB TRAY
- K963722 — IV START KIT
- K963723 — LACERATION TRAY
- K963735 — COJET SYSTEM
- K963788 — PRIMOFOCUS COMPACT
- K963798 — SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
- K963805 — PRODIGY AC
- K963875 — AHS OMEGA K-AMP
- K963941 — THE PHARAOH COMPENSATING FILTER
- K963999 — AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
- K964094 — MINIFIX
- K964109 — MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
- K964144 — PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
- K964214 — STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
- K964244 — STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
- K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
- K964310 — VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
- K964349 — AIA-PACK FOLATE ASSAY
- K964451 — PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
- K964502 — UNITRON MODEL SOUND F/XP +4
- K964503 — UNITRON MODEL SOUND F/X +4
- K964504 — UNITRON MODEL ICON AOHPL +4
- K964508 — UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
- K964510 — UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
- K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
- K964530 — DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
- K964557 — RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
- K953252 — DISPOSABLE SCALP VEIN INFUSION SET
- K955756 — KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
- K961656 — TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
- K962045 — ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
- K962205 — STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
- K962623 — OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
- K962631 — DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM
- K962816 — SPERM PREPARATION MEDIA
- K963183 — BIOZ SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.