FDA 510(k) clearances — page 403
clearances on record, most recent first.
Clearances — page 403
40,201–40,300 of 175,770- K131296 — VARILIFT-L INTERBODY FUSION DEVICE
- K131540 — INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
- K132366 — SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
- K132455 — U-MOTION II PS+ CUP
- K123792 — HORIZON XVU (FFR)
- K124044 — ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
- K130165 — PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
- K130610 — SIRIUS FEMORAL STEM
- K130792 — LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
- K130931 — EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
- K131184 — INTEGRA LICOX PTO2 MONITOR
- K131241 — SWIP
- K131363 — ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
- K131378 — SUS (STENFILCON A) CONTACT LENS
- K131430 — CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL
- K131455 — RESTORE MODULAR STERILIZATION TRAY SYSTEM
- K131558 — PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
- K131576 — OPTIMA CT660
- K131784 — RANGE SPINAL SYSTEM
- K131818 — VITAL SIGNS MONITOR
- K132146 — SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
- K132207 — UTF STEM-REDUCED, ADDITIONAL SIZES
- K132281 — ReVive PV (Peripheral Vasculature) Thrombectomy Device
- K132359 — MRI PATIENT MONITORING SYSTEM
- K132374 — BAYLIS MEDICAL RF PERFORATION PROBE V2.0
- K122885 — MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
- K123540 — SYNGO CT PULMO 3D
- K123947 — ARCHITECT IVANCOMYCIN
- K130242 — MAVEN PRO
- K130266 — ENDOWRIST ONE VESSEL SEALER
- K130374 — OMNI-VUE 2 SYSTEM
- K130727 — ENSITE VELOCITY SYSTEM
- K130868 — NUVASIVE DECADE LATERAL PLATE SYSTEM
- K131200 — ASPIRON ACP SYSTEM
- K131294 — OMNIPOD INSULIN MANAGEMENT SYSTEM
- K131408 — CR 12-X DIGITIZER
- K131594 — EZDENTI-I; E2; PRORA VIEW
- K131611 — FRESENIUS DRY ACID DISSOLUTION UNITS
- K131614 — REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
- K131616 — EZ3D-I, E3
- K131635 — ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
- K131728 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY
- K131780 — EVIS EXERA III VIDEO SYSTEM
- K132012 — TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
- K132409 — CONCIERGE GUIDING CATHETER
- K132413 — MZ1000
- K132587 — MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR
- K121925 — POWDERED LATEX SURGEON'S GLOVE
- K122197 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
- K123724 — DERMISEB CREAM
- K123999 — ILLUMASK ACNE LIGHT THERAPY MASK
- K130461 — STALIF X
- K130716 — BIORETEC ACTIVASCREW INTERFERENCE
- K131048 — LIDCO CNAP MODULE
- K131061 — RESTORE BUNION CORRECTION SYSTEM
- K131124 — COLIGN
- K131155 — UGFT3; FHT7
- K131170 — SONICISION STERILIZATION TRAY
- K131221 — LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
- K131223 — CARESCAPE MONITOR B650
- K131277 — SEVIIN FRACTURE SHOULDER
- K131414 — CARESCAPE MONITOR B850
- K131471 — SELF-COMPRESSIVE SCREW
- K131507 — XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
- K131582 — SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
- K131641 — MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
- K132234 — LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
- K123797 — NT1D VITAL SIGNS MONITOR
- K123987 — IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
- K130462 — PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
- K131049 — ZRP
- K131068 — TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID
- K131197 — EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
- K131198 — TIPI OTC
- K131376 — SMARTCOAT 2.5% NAF VARNISH
- K132360 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
- K123436 — FIRST RESPONSE EARLY RESULT PREGNANCY TEST
- K130130 — ATG/SM-OSA APPLIANCES
- K130635 — SEVIIN SURFACE REPLACEMENT SHOULDER
- K131082 — INTERFORM INTERBODY CAGE SYSTEM
- K131101 — ITERO SOFTWARE
- K131212 — PREMIER CERAMIC PRIMER
- K131527 — LOGIQ S8
- K131949 — AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
- K132237 — PRODESSE PROFAST+ ASSAY
- K132238 — PROPARAFLU+ ASSAY
- K122355 — VANISHPOINT BLOOD COLLECTION SET
- K124010 — ACCUSONIC ADVANTAGE
- K130137 — BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
- K130244 — DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K130268 — BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
- K130403 — MAGSTIM DOUBLE 70-2 COIL
- K130516 — CARDIODAY
- K130798 — PRE-FORMED GUIDEWIRES
- K131012 — SUTTER BIPOLAR FORCEPS - SUPERGLISS
- K131374 — TEMPUS(TM) CERVICAL PLATE SYSTEM
- K131878 — LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
- K131978 — SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
- K132054 — GYNECARE TVT EXACT CONTINENCE SYSTEM
- K132268 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Data sourced from openFDA. This site is unofficial and independent of the FDA.