FDA 510(k) clearances — page 411
clearances on record, most recent first.
Clearances — page 411
41,001–41,100 of 176,542- 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
- K132535 — AUTOBAND LIGATOR
- K122100 — POWDERED VINYL EXAMINATION GLOVES
- K122627 — GIO DIGITAL PRESSURE GUAGES
- K130012 — WET PLATINUM PERSONAL LUBRICANT
- K130027 — DISPOSABLE NEUTRAL ELECTRODE GP202
- K130076 — PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
- K130301 — LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
- K130714 — PROGIGY SUPPORT CATHETER
- K130936 — AERODR SYSTEM WITH P-31
- K130951 — SIM
- K131085 — CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
- K131097 — LEGACY3 6MM LENGTH IMPLANTS
- K131126 — OPTI CCA-TS2
- K131310 — GMK FULL PE TIBIAL COMPONENTS
- K131432 — CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND
- K131451 — PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
- K131523 — CRYOBALLOON FOCAL ABLATION SYSTEM
- K131581 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
- K131657 — FLOWER SMALL AND MEDIUM IMPLANT SET
- K131707 — 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
- K131736 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
- K131884 — AVENIR CEMENTED HIP STEM
- K131969 — SYMBOTEX(TM) COMPOSITE MESH
- K132099 — ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
- K132169 — SURGIQUEST AIRSEAL IFS
- K132204 — INSUFLOW SYNERGY XL PORT
- K132332 — MOUNTAINEER OCT SPINAL SYSTEM
- K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.