FDA 510(k) clearances — page 403
clearances on record, most recent first.
Clearances — page 403
40,201–40,300 of 176,542- K130467 — POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
- K130788 — CAPELLA
- K131095 — DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
- K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
- K131497 — MCKESSON CARDIOLOGY HEMO
- K131682 — UD IMPLANT SYSTEM
- K132079 — TFCC FAST-FIX KIT
- K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
- K132153 — SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
- K132285 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K132640 — IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
- K132904 — ZIEHM VISION RFD
- K132966 — GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
- K132994 — ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
- K133213 — STARCERAM
- K133376 — AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
- K133411 — ALERE BINAXNOW INFLUENZA A & B CARD
- K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
- K122952 — NIPRO PUREFLUX-L HEMODIALYZER
- K130375 — SELF-RETAINING BICANALICULUS INTUBATON SET II
- K131957 — MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
- K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE
- K132033 — BM3/BM3 PLUS
- K132148 — S HEALTH
- K132232 — MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
- K132437 — MARS HOLTER ANALYSIS WORKSTATION
- K132466 — MYLABSEVEN 6400, MYLABALPHA 7400
- K132533 — CARESCAPE MONITOR B450
- K132584 — PERIMETER C SPINAL SYSTEM
- K132604 — VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
- K132748 — BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
- K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
- K123474 — AVANT LASER
- K130329 — SURGISEAL TOPICAL SKIN ADHESIVE
- K131929 — SURVEYOR CENTRAL STATION
- K132463 — CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
- K132742 — M-VU BREAST DENSITY
- K132743 — HARVESTING CANNULA
- K132974 — AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
- K133181 — 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
- K133185 — 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
- K133202 — HEM-O-LOK LIGATING CLIP
- K133314 — HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
- K121812 — SONIXGPS
- K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
- K132134 — OPTIFIX ABSORBABLE FIXATION SYSTEM
- K132270 — COBAS CT/NG V2.0 TEST
- K132514 — KINSA SMART THERMOMETER
- K132896 — CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
- K133437 — 1ST MTP PLATE
- K131686 — INOMAX DSIR (DELIVERY SYSTEM)
- K132726 — ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
- K132848 — PIEZOSURGERY FLEX
- K132970 — LESSRAY
- K133420 — TRANQUILL BARBED DEVICE
- K130565 — SPECULAR MICROSCOPE CEM-530
- K131016 — ROGS
- K131025 — ARCHON ANTERIOR CERVICAL PLATE SYSTEM
- K131142 — GENESIS LED WANDS
- K131383 — X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
- K131390 — JUSHA-M52C MEDICAL DISPLAY
- K131591 — FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
- K132201 — SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
- K132231 — MYLABSEVEN, MYLABALPHA
- K132658 — HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
- K132687 — E-CUBE 7
- K133061 — ESPIN SYSTEM
- K133086 — TITLE 2 POLYAXIAL SPINAL SYSTEM
- K133091 — ZIP MIS INTERSPINOUS FUSION SYSTEM
- K133282 — REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
- K133329 — UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
- K122024 — SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
- K122340 — PRODIGY CHOICE
- K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
- K131302 — SOLAX
- K131369 — FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
- K131629 — NEURODYN MULTIWAVE, AUSSIE SPORT
- K131646 — DISPOSABLE INFUSION SET
- K131699 — EMOTION ECG MOBILE
- K131828 — POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
- K131897 — CV3000 HOLTER ANALYSIS SYSTEM
- K131913 — INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
- K131997 — NEWTRON BOOSTER
- K131998 — ASPIRE RX-LP6 ASPIRATION CATHETER
- K132170 — SHASER V-MINI RX
- K132372 — STERITEC GREEN CARD PACK BOWIE-DICK TEST
- K132526 — KNIT-PAK+
- K132624 — TRIATHLON TRITANIUM METAL-BACKED PATELLA
- K132699 — AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
- K132740 — SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
- K132795 — CYBERWAND STERILE PROBE SET
- K132822 — BD MAX STAPHSR ASSAY, INSTRUMENT
- K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
- K130135 — DANA REUSABLE BI TEST PACK
- K130777 — INBODY
- K130856 — BIA / VITALITY ANALYZER
- K131339 — CAPNOMASK
- K132029 — VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
- K132101 — ANAX 5.5 SPINAL SYSTEM
- K132217 — ARTHREX COMPRESSION FT SCREWS
Data sourced from openFDA. This site is unofficial and independent of the FDA.