FDA 510(k) clearances — page 473
clearances on record, most recent first.
Clearances — page 473
47,201–47,300 of 175,770- K110688 — MYLABGOLD
- K110773 — TORNIER INSITE FT SUTURE ANCHOR
- K111252 — ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
- K100980 — INVADER FACTOR V
- K103023 — UNIT, PHACOFRAGMENTATION
- K103423 — MIS ANTERIOR CERVICAL PLATING SYSTEM
- K103738 — H-WAVE
- K110398 — RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
- K110516 — CONNEX VITAL SIGNS MONITOR 6000 SERIES
- K111229 — JETSTREAM G3 (R) SF 1.6 SYSTEM
- K110268 — FORCETRIAD ELECTROSURGICAL GENERATOR
- K110957 — M4 MONITOR
- K111295 — .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
- K092338 — MEDAX UNIPERSONALE SRL
- K100895 — PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
- K101251 — IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
- K101681 — TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
- K101952 — KONIX ULTRASOUND GEL
- K102049 — CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
- K102935 — INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A
- K103775 — PEAK SUCTION COAGULATOR
- K110097 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
- K110214 — DIRECTVISION CATHETER, UNCOATED
- K110226 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
- K110233 — HAIRMAX LASERCOMB
- K110256 — THE IC-PRO SYSTEM
- K110447 — ECHOINSIGHT
- K110589 — CIMARA
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.