FDA 510(k) clearances — page 481
clearances on record, most recent first.
Clearances — page 481
48,001–48,100 of 176,542- K110641 — FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
- K110642 — SILJETR SYSTEM
- K110781 — 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
- K110785 — KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
- K111098 — INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
- K111251 — 4CH FLEX SPEEDER
- K111283 — GMK REVISION HYBRID LINERS
- K111330 — AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
- K100831 — CYFRA 21-1 EIA MODEL 211-10
- K101128 — BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
- K103653 — E3 TORQUE CONTROL MOTOR
- K110090 — AFX INTRODUCER SYSTEM
- K110422 — SURGICAL STIMULATORS
- K110718 — CELL-CHEX WITH CPPD CRYSTALS
- K111042 — ATRICURE CRYO MODULE
- K081868 — SMART LEISH, MODEL LGM1-050
- K092268 — RANDOX BARITURATES ASSAY
- K102463 — GOOD NIGHT
- K102466 — FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
- K102894 — CLASSIX CHEMICAL STERILIZATION INDICATOR
- K103514 — PRO-V COAT
- K103692 — SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
- K110132 — MUSE CARDIOLOGY INFORMATION SYSTEM
- K110251 — SYNCHRON MULTI CALIBRATOR
- K110321 — TIGER SPINE SYSTEM
- K110473 — NANOTACK SUTURE ANCHOR 1.4MM
- K110588 — LEUCADIA PEDICLE SCREW SYSTEM
- K110807 — ABG II MONOLITHIC HIP STEM
- K102534 — AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE
- K103421 — ARSTASIS DILATOR ADAPTER
- K110746 — 4D LV-ANALYSIS 3.0
- K110905 — TOTAL SHOULDER SYSTEM
- K111153 — SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
- K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SET
- K111183 — ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
- K111230 — SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
- K111336 — EBW NM 2.0
- K111384 — LIFEBRIDGE
- K101037 — EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
- K102199 — OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
- K103500 — GORE EMBOLIC FILTER
- K110155 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
- K110489 — SLIT LAMP SL-2G
- K110676 — TSRH SPINAL SYSTEM
- K110792 — GELPOINT PATH
- K111154 — SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
- K092801 — ABS BLOWER, ABS NOZZLE, MODEL 1001
- K101090 — EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
- K102512 — RMS SUBCUTANEOUS NEEDLE SET
- K102740 — NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
- K102946 — CORELEADER COLLA-PAD MODEL CS 03030
- K102970 — GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
- K103067 — EXSALT SD7 WOUND DRESSING
- K103207 — JBAIDS Q FEVER DETECTION KIT
- K103382 — INTERCONTINENTAL PLATE-SPACER
- K103603 — ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
- K103723 — SICAT IMPLANT V1.2
- K103797 — K2M COCR WIRE
- K103801 — HYPOTHERMX INTRAVENOUS FLUID WARMER
- K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM
- K110015 — VITALSENS, AINGEAL, V-POD
- K110166 — CLEARCUT S SAFETY KNIFE
- K110182 — CANNABINOIDS URINE TEST
- K110495 — LIFTKAR PT
- K110578 — MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
- K110803 — SURESIGNS VSI VITAL SIGNS MONITOR
- K110872 — WITHINGS BLOOD PRESSURE MONITOR
- K111052 — SYNGO NEURO PBV-IR
- K111114 — SURESIGNS VS2 VITAL SIGNS MONITOR
- K111137 — HYDROFIX VASO SHIELD
- K100547 — ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
- K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
- K103509 — UNIMAX SUCTION IRRIGATION SET
- K103822 — SYNTHES HEMOSTATIC BONE PUTTY (HBP)
- K110230 — ROG KNOTLESS SUTURE ANCHOR
- K110283 — ZENIUS SPINAL SYSTEM
- K110302 — ADHESIVE EXL-759
- K110335 — CERAMIC BRACKETS
- K110533 — STRYKER PATIENT SPECIFIC CUTTING GUIDE
- K110709 — ARK CARE DIABETES MANAGMENT SYSTEM
- K111039 — ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
- K101946 — VIDAS TOXO IGG AVIDITY
- K102733 — VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
- K103377 — CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
- K103560 — SHASER IPL HAIR REMOVAL SYSTEM
- K103812 — MITRA-LIFT
- K110006 — OIS SYMPHONY IMAGE MANAGMENT SYSTEM
- K110229 — ROG SUTURE ANCHOR 5.5MM, 2.9MM
- K110574 — BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
- K111064 — TIGERPAW SYSTEM II
- K083423 — COLONCAD API 3.1
- K102251 — DASH KNEE
- K102317 — IQ VENTILATION NASAL MASK
- K103094 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
- K103765 — MAC 600 RESTING ECG ANALYSIS SYSTEM
- K110188 — DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
- K110484 — SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
- K110706 — EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
- K110722 — RPS ADENO DETECTOR PLUS
- K111001 — STERILE STORM (R) OPERATING KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.