FDA 510(k) clearances — page 394
clearances on record, most recent first.
Clearances — page 394
39,301–39,400 of 175,770- K132837 — LINA POWERBLADE PLUS
- K132952 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
- K133346 — SMARTLOG DIABETES MANAGEMENT SOFTWARE
- K133475 — STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
- K133511 — 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
- K133561 — VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
- DEN110009 — RESTLESS LEG DEVICE
- DEN110011 — SYMPHONY DEVICE
- DEN130007 — AXIOS STENT AND DELIVERY SYSTEM
- K130797 — LUCO HYBRID OSA APPLIANCE
- K131379 — EARLYSENSE
- K131664 — COPRA TEMP PMMA-DISK
- K131758 — SURGEN U
- K132186 — OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
- K132418 — COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
- K132876 — ARIX HAND LOCKING SYSTEM
- K132878 — M.U.S.T. EXTENSION
- K132992 — TI STAR IMPLANT SYSTEM
- K133440 — AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
- K133460 — APTUS CANNULATED COMPRESSION SCREWS
- K133586 — VISI MOBILE MONITIORING SYSTEM
- K133637 — ALERE INFLUENZA A & B TEST
- K130652 — VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
- K130736 — BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
- K131919 — ZOLL EPCR IOS
- K132218 — PERFIX ILIAC SCREW SYSTEM
- K132264 — PRIMADO2 TOTAL SURGICAL SYSTEM
- K132340 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
- K132996 — CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
- K133079 — IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)
- K133188 — MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
- K133243 — OPTION ELITE VENA CAVA FILTER SYSTEM
- K133246 — ZIMMER DISTAL RADIUS PLATING SYSTEM
- K133291 — ST360 DEGREES SPINAL FIXATION SYSTEM
- K133342 — ARTHREX IBALANCE TKA SYSTEM
- K123678 — HYALMIX CREAM
- K130073 — MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
- K131060 — CLEARGUARD HD END CAP
- K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
- K131952 — CORIN METAFIX HIP STEM
- K131986 — CORIN MINIHIP STEM
- K132147 — 2D PERFUSION
- K132240 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
- K132253 — REMOVABLE PATIENT LEADS ECG CABLE
- K132522 — HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
- K132618 — ONETOUCH REVEAL
- K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
- K132785 — STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
- K132910 — DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
- K132963 — FUSIONSYNC, CHIMAERA FUSIONSYNC
- K133305 — RHYTHM VIEW WORKSTATION
- K133454 — SONOSITE EDGE ULTRASOUND SYSTEM
- DEN130022 — NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
- K121248 — LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
- K122035 — HEPAFAT SCAN
- K130704 — MICRODOSE SI
- K130738 — ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
- K130913 — GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
- K131979 — PROVANT THERAPY SYSTEM
- K131996 — S-SCAN
- K132015 — TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
- K132060 — DURABLUE STERILIZATION WRAP
- K132441 — BARD VENTRALEX HERNIA PATCH
- K132484 — DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
- K132594 — CROSSCHECK PLATING SYSTEM
- K133035 — NORMED PELLEGRIN CALCANEUS STOP SCREW
- K123861 — AIDI DENTAL IMPLANT SYSTEM
- K130439 — EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
- K131766 — PLATINUM DRF IMAGING SYSTEM
- K132120 — WTF SECURA SYRINGE AND NEEDLE
- K132177 — MEDCOMP GEN III POWER INJECTABLE PORT
- K132523 — MYOPERFUSION
- K132558 — SYNC-RX SYSTEM
- K132754 — NEOGEN PSR SYSTEM
- K132803 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
- K132862 — HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
- K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
- K133230 — INQWIRE DIAGNOSTIC GUIDE WIRE
- K133435 — MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
- K121873 — AVINENT DENTAL IMPLANT SYSTEM
- K122834 — POLYSITE IMPLANTABLE INFUSION PORTS
- K123728 — RETRIEVAL BAG
- K130317 — GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
- K130708 — SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
- K130758 — KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
- K131596 — WOUND MEASURING & MONITORING DEVICE
- K131649 — ME
- K132028 — ULTHERA SYSTEM
- K132773 — SIDEXIS 4
- K132873 — VANGUARD XP KNEE SYSTEM
- K132897 — CLYDESDALE SPINAL SYSTEM
- K133094 — CERTEX OCT SPINAL IMPLANT SYSTEM
- K133180 — ERBE ESU MODEL VIO DV WITH ACCESSORIES
- K133687 — THD N-ANO ANOSCOPE
- K122393 — TG-BODY MI&BODY S-TRAINER
- K123248 — CPR RSQ ASSIST
- K131586 — CANARY BREATHING SYSTEM
- K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
- K133474 — BIOSIGN FLU A + B, STATUS FLU A & B
- K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.