FDA 510(k) clearances — page 952
clearances on record, most recent first.
Clearances — page 952
95,101–95,200 of 175,890- K970361 — LASER EYE GOGGLES
- K970467 — EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
- K970613 — PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)
- K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
- K970696 — S.P. 100
- K955663 — ABC IN-LINE BLOOD SAMPLING KIT
- K961021 — KIRSCHNER KNEE MODIFIED
- K961380 — CPC PROBE
- K962433 — MEADOX EXXCEL EPTFE VASCULAR GRAFT
- K963315 — VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE
- K964029 — EMERGENCY RELIEF KIT SYSTEM
- K964128 — MCL 29 DERMABLATE ERBIUM LASER SYSTEM
- K964416 — SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
- K964932 — ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR
- K964987 — DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
- K965028 — ACUMED SUTURE WASHER
- K965077 — SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS
- K965101 — CARDIOBEEPER CB-12L
- K965127 — DGH MODEL 9000
- K965193 — LIBERTY ANTERIOR SPINAL SYSTEM
- K965203 — RADX SYSTEM
- K970034 — SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
- K970064 — AMICAS WEB/INTRANET IMAGE SERVER
- K970155 — NEURO-TRAIN II (2)
- K970555 — IL0292 DP ECHOPORT
- K950017 — FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
- K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
- K965015 — TOPAZ 30 SURGICAL LASER SYSTEM
- K965017 — REGIONAL ANESTHESIA TRAYS
- K965020 — POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
- K965046 — ISOLA TWISTER CONNECTOR
- K970042 — OOLI-U(TONGUE SCRAPER)
- K970114 — ULTRACAL XS
- K970807 — MOBILE OPERATING TABLE 1132.01
- K970825 — BLUE CHIP GERMICIDAL CLEANER & DEODORANT
- K961343 — MEDVISION PERSONAL MONITOR
- K961360 — TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
- K961986 — MANAN D BAG
- K962109 — SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL
- K962723 — TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
- K962791 — NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM
- K963174 — HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
- K964375 — SYSMEX SE/RAM-1
- K964882 — IMPLEX REPLACEMENT ACETABULAR CUP INSERT
- K965145 — DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
- K965164 — HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
- K965175 — HOWMEDICA MAINSTAY ANCHOR
- K970013 — BIORIGID NAIL TIBIA
- K970084 — LINK CERCLAGE WIRE SYSTEM
- K970097 — PROXIMAL FEMORAL NAIL (PFN) SYSTEM
- K970704 — PERSONAL CATHETER
- K955179 — CONTRAST MEDIA SET
- K961144 — MS-2000
- K961835 — PROTIME MICROCOAGULATION SYSTEM
- K965051 — HEARTPORT NEEDLE TROCAR
- K965161 — SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
- K965182 — RFG-3CF
- K965254 — WIDEX MODEL SENSO DIGITAL (C9)
- K970037 — TARGOGRID
- K970598 — INTEGRATED VISUALIZATION SYSTEM
- K955841 — SLEEP SYSTEM FOR CLINICS & RESEARCH
- K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
- K962605 — PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
- K963001 — LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
- K963273 — VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
- K963388 — VESSEL DILATOR
- K963608 — QUANTITATIVE SENTINEL SYSTEM
- K963787 — EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
- K963894 — SMARTGUIDE
- K964342 — CYTOPLAST GBR
- K964474 — ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
- K964636 — FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM
- K964902 — CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
- K964979 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
- K965004 — C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
- K965012 — LIFESTYLE BREAK THRU (POLYMACON)
- K965058 — NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
- K965082 — SOOTHING WATER-FILLED TEETHER
- K965107 — MEDLINE ADMISSION KITS
- K965170 — ROCCOBAROCCO & PRO-DYNAMIX
- K965211 — VISTA BRITE TIP CATHETERS
- K970063 — SERIES 7600 MOBILE DIGITAL C-ARM
- K970079 — PROXIMATE DISPOSABLE SKIN STAPLER
- K970240 — DIFFUSER PANEL
- K970256 — INTRAORAL MANDIBULAR DISTRACTION DEVICE
- K970313 — PREPOWDERED LATEX EXAMINATION GLOVE
- K970372 — GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
- K970427 — KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
- K970430 — ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
- K970560 — URIC ACID (LIQUID) REAGENT SET
- K961269 — PULSEMASTER
- K962323 — IMMULITE OPIATES SCREEN/CONTROL MODULE
- K964231 — NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
- K964538 — R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
- K964604 — BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
- K964865 — PVK-720ST ENDOCAVITARY TRANSDUCER
- K964909 — ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
- K964910 — AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS
- K964959 — VASCUTEK TWILLWEAVE VASCULAR GRAFT
- K964973 — GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
Data sourced from openFDA. This site is unofficial and independent of the FDA.