FDA 510(k) clearances — page 390
clearances on record, most recent first.
Clearances — page 390
38,901–39,000 of 175,770- K133394 — AIRSTRIP REMOTE PATIENT MONITORING
- K133396 — VDRIVE WITH V-SONO
- K133523 — STAPIX SUPERELASTIC IMPLANT BONE STAPLES
- K133701 — NUVANT MCT SYSTEM
- K140036 — APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
- K132613 — SONILASE LIGHT THERAPY DEVICE
- K133550 — VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
- K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
- K133666 — RT016 INSPIRATORY FILTER
- K133867 — SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
- K140015 — CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
- K130320 — BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
- K130582 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K131653 — LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
- K132140 — DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
- K132383 — GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
- K132602 — STREAMLINE EXPRESS
- K132886 — SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
- K133737 — ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
- K133757 — GFS II STANDARD, GFS II LARGE, GFS MIMI
- K133794 — 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3
- K123475 — SHOOCIN INTRODUCER KIT
- K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
- K131292 — DEROYAL SPINE SPACER SYSTEM
- K132767 — MEDLINE SHARPS CONTAINER
- K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA
- K133557 — JULIET LL LATERAL LUMBAR CAGE
- K130003 — XIRALITE FLOURESCENCE IMAGING SYSTEM X4
- K131555 — MEDSOURCE IV SAFETY CATHETER
- K131571 — AVD RIGHT RADIAL DRAPE
- K131592 — ENLIGHTN RENAL GUIDE CATHETER
- K131696 — VESALIUS
- K131907 — RAYPEX 6
- K132070 — VITA SUPRINITY(R)
- K132135 — LINA GOLD LOOP HC
- K132221 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K132356 — SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
- K132792 — ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
- K132807 — MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
- K133034 — LOGIQ F SERIES
- K133038 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
- K133240 — VARIAN MULTILEAF COLLIMATOR
- K133343 — WONDFO RAPID STREP A TEST
- K133655 — RADIANCE V2
- K133730 — CO PILOT/REGIUS UNITEA
- K133796 — NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),
- K133855 — BREEZY ELEGANCE
- K133967 — INTERBODY CAGE SYSTEM
- K134002 — 6MP COLOR LCD MONITOR, RADIFORCE RX650
- K140012 — SORIN FLEXTHERM
- K130872 — CARDIOCEL
- K131344 — POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
- K131833 — CENTURION POCT SYSTEM
- K132474 — CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
- K132643 — UV PHOTOTHERAPY
- K132746 — NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
- K132758 — DIGITAL ELECTROCARDIOGRAPH
- K132770 — DOME S10
- K133184 — ARDIS INTERBODY SYSTEM
- K133192 — MECTALIF TIPEEK
- K133229 — TITANIUM SUTURE ANCHOR
- K133275 — MINI TIGHTROPE
- K133681 — CRUX SNARE FILTER RETRIEVAL SET
- K140019 — ARTHREX BIOSUTURE
- DEN120023 — GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
- K131204 — ADVANCE CS CORONARY SINUS INFUSION CATHETER
- K131444 — UA-CELLULAR COMPLETE
- K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGER
- K132721 — SPIWAY ENDONASAL ACCESS GUIDE
- K133176 — AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
- K133236 — TANDEMHEART FEMORAL VENOUS CANNULA SET
- K133355 — CADWELL FLEX EEG/PSG
- DEN130036 — PROSTATE IMMOBILIZER RECTAL BALLOON
- K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
- K131413 — XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
- K133541 — EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM
- K133723 — OTC PATCH
- K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
- K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
- K132444 — ATAMA SYSTEM
- K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K133103 — AVERSION PEDICLE SCREW SYSTEM
- K133331 — 4D INTEGRATED TREATMENT CONSOLE
- K133354 — PERI-PROSTHETIC CABLE SYSTEM
- K133785 — TRITIUM STERNAL CABLE PLATE SYSTEM
- K133986 — 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
- K131307 — ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
- K131457 — FETAL ULTRASONIC MONITOR AND ACCESSORIES
- K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
- K131910 — MPP
- K132057 — DYNATRON PELTIER THERMOSTIM PROBE
- K132300 — EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
- K132616 — EPAD
- K132782 — CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
- K132815 — PUREGRAFT 50 SYSTEM
- K132817 — KIVA VCF TREATMENT SYSTEM
- K133013 — INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
- K133259 — YSIO MAX
- K133602 — ADD-VANTAGE ADDAPTOR
- K133642 — RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
Data sourced from openFDA. This site is unofficial and independent of the FDA.