FDA 510(k) clearances — page 487
clearances on record, most recent first.
Clearances — page 487
48,601–48,700 of 176,542- K110476 — AXSOS (TM) LOCKING PLATE SYSTEM
- K110482 — PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
- K110553 — ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
- K110601 — SENTINELLA 102
- K102164 — HEMOSIL PROTEIN S ACTIVITY ASSAY
- K102190 — WINSTIM
- K102846 — PATIENT EXAMINATION GLOVES
- K103072 — REVERE SACRAL PLATES
- K103416 — NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
- K103440 — EVEREST SPINAL SYSTEM
- K103546 — AYCAN WORKSTATION OSIRIX PRO
- K103664 — PRIMUS AESTHETIC PLATFORM
- K103689 — PLANMECA PROMAX 3D MID
- K103742 — ACCELL EVO3 (FORMERLY ACCELL A2I)
- K103743 — CONCORDE CURVE SYSTEM
- K103814 — PEZO INTERBODY CAGES SYSTEM
- K110028 — MASIMO RADICAL Y PULSE CO-OXIMETER
- K110371 — ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY
- K110445 — FLEXFUSION (TM) FIXATION IMPLANT
- K101374 — AAXTER A3 POSTERIOR SPINAL SYSTEM
- K101947 — IVD-GE02
- K102727 — LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
- K103246 — IPLAN RT
- K103265 — NHANES WHOLE BODY DXA REFERENCE DATABASE
- K103375 — PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
- K103384 — ESCALADE ACETABULAR CUP SYSTEM
- K103504 — GETINGE 400HC/500HC SERIES STEAM STERILIZER
- K103720 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
- K103773 — ZENOFLEX DIMENSION
- K110108 — MODALIXX
- K110347 — DOPPLER MONITOR
- K110412 — IDS-ISYS IFG-I CONTROL SET
- K110444 — MIRAGE MICRO
- K110453 — RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K110491 — BACKSTOP CATHETER
- K101930 — MEMOMETAL NAVIS BONE PLATING SYSTEM
- K102563 — SINGLE CANNULA EXTENDED APPLICATOR
- K102839 — SPIDER STANDARD AND ADVANCED
- K103404 — ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
- K103409 — ALLERGEAZE R CLEAR
- K103505 — ALTUM ANTERIOR CERVICAL PLATE
- K103686 — STAR 50 N
- K103700 — ESSENTIAL MRI PATIENT MONITOR
- K103756 — DEPUY ATTUNE TOTAL KNEE SYSTEM
- K103841 — BELIMED STEAM STERILIZER MST-V
- K110018 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K100698 — STCC
- K101338 — NEWFIX EXTERNAL FIXATION SYSTEM
- K101552 — FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
- K102253 — ECHO BLASTER
- K102334 — TRANS1 AXIALIF PLUS
- K103114 — OSSPRAY SYLC CR
- K103156 — V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
- K103471 — UBM PLUS
- K110458 — SILVER ANTIMICROBIAL WOUND GEL
- K100569 — MERIT EMBOLECTOMY CATHETER MODEL ASAP100
- K101458 — LINA XCISE MODEL MOR-1515
- K101607 — BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS
- K101608 — BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS
- K101913 — ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
- K102102 — COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K102515 — NP15
- K102692 — SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
- K102821 — DISCOVRED
- K102919 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
- K103134 — FUKUDA DENSHI
- K103146 — ISOGRAY TREATMENT PLANNING SYSTEM
- K103148 — AIDA DIAGNOSTIC ULTRASOUND SYSTEM
- K103172 — CIV-OB (PLUS)
- K103371 — COUDE/ OR TIEMANN
- K103493 — HEAD FIATION DEVICE (HFD 100)
- K103712 — GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
- K103763 — STELLAR 300
- K110343 — TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
- K110389 — STEALTH 360 ORBITAL PAD SYSTEM
- K110511 — E4D COMPASS
- K092433 — DYSIS
- K093736 — DEPUY CORAIL HIP SYSTEM, REVISION STEM
- K102704 — EASY CUFF
- K103053 — VERIFY 270FP CHALLENGE PACK
- K103123 — APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
- K103479 — NOVEL TAPERED HIP STEM
- K103537 — ET III SA ULTRA WIDE SYSTEM
- K103709 — CERACELL DENTAL
- K110503 — AIRSTRIP REMOTE PATIENT MONITORING (RPM)
- K103518 — TRINITY ACETABULAR SYSTEM
- K103649 — VOLUSON S6, VOLUSON S8
- K101901 — IPL THERAPY SYSTEM
- K103191 — QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
- K110361 — ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
- K100370 — SYMMETRIC TOTAL KNEE AGUMENTS
- K100928 — MICRO DIARY SPIROMETER
- K101250 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
- K101790 — QUANTUM SPINAL SYSTEM, QUANTUM MIS
- K101854 — ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
- K101985 — ASAHI GUIDE WIRE EXTENSION 165CM
- K102064 — BD FACS SAMPLE PREP ASSISTANT III (SPA III)
- K102574 — PALLA M SPINAL SYSTEM
- K102964 — EU-TTG IGA AND EU-TTG IGG
- K103169 — ALEUTTIAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.