FDA 510(k) clearances — page 612
clearances on record, most recent first.
Clearances — page 612
61,101–61,200 of 175,825- K061428 — PMP4 APPLICATION
- K061876 — CODMAN VPV SYSTEM, MODEL 82-3192
- K062215 — CONFIDANT 2.0
- K062240 — CAREVENT
- K062312 — AXIOM PULSED LIGHT SYSTEM
- K062456 — NOVASPINE POWERED SUCTION PUMP PRO-1
- K062481 — SERENO ELECTRONIC STETHOSCOPE
- K062668 — AUDIT MICROCV IMMUNOASSAY LINEARITY SET
- K062959 — DMS 300-2, 300-3 AND 300-4
- K063032 — COMFORT SCOOTER, MODEL LY-EW415
- K051436 — PRE' VAGINAL LUBRICANT
- K052229 — COLOPLAST OSTOMY ROD, MODEL 12814
- K060158 — NET-2000 MICROCURRENT STIMULATOR
- K060669 — MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
- K061070 — HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
- K061413 — APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
- K061544 — STELLARTECH 100 COAGULATION SYSTEM
- K061679 — WALLACE ARTIFICIAL INSEMINATION CATHETER
- K062097 — VERESS CANNULA AND MODULAR VERESS CANNULA
- K062157 — CONFORM
- K062301 — DEPUY LPS PROXIMAL TIBIAL COMPONENT
- K062495 — HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
- K062681 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K062696 — SURGISIS, SURGISIS ES
- K062697 — SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
- K062742 — CR 85-X
- K062767 — CTL-63 AND CTL-128 SPINE ARRAY COILS
- K062768 — NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL
- K062773 — MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
- K062805 — MODIFICATION TO ENDO-EASE
- K062808 — LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
- K062846 — COLLAGEN DENTAL MEMBRANE III
- K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
- K062923 — MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
- K062935 — HABIB 4X LAPAROSCOPIC
- K062972 — PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
- DEN060007 — INTROL CF PANEL I CONTROL
- K060458 — MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
- K061001 — THERMASSAGE
- K061046 — CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
- K061847 — ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S
- K062144 — ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
- K062927 — MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
- K050158 — SINCLAIR SEBORRHEA EMULSION
- K053585 — VANGUARD REPROCESSED SUTURE PASSER
- K060163 — CARDIOFLON, CARDIOXYL
- K062520 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K062663 — MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
- K062698 — TRIO + SPINAL SYSTEM
- K062727 — CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
- K062790 — WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
- K062881 — COLLAGEN DENTAL MENBRANE - CONFORMABLE II
- K053538 — MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
- K060538 — BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568
- K061417 — GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910
- K061660 — STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
- K062209 — BASX BLADELESS TROCAR
- K062257 — STARION INSTRUMENTS THERMAL LITIGATING SHEARS
- K062309 — KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105
- K062421 — MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
- K062729 — SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
- K062777 — MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
- K062829 — DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
- K050197 — MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
- K052223 — ACCESS EPO ASSAY
- K053590 — SILVERLON CA (CALCIUM ALGINATE)
- K060927 — CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
- K061219 — D-STAT DRY HEMOSTATIC BANDAGE
- K061232 — ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
- K061362 — PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
- K061614 — TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS
- K061804 — ZERION ALPHA, ; ZERION BETA
- K062054 — 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
- K062136 — PASS 2 SPINAL SYSTEM
- K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
- K062552 — RTVUE
- K062609 — MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
- K062634 — ORTHOXP
- K062685 — EBI ARAY SPINAL SYSTEM
- K062818 — FLEXITOUCH SYSTEM
- K061408 — EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
- K061465 — KMI CEMENT RESTRICTOR IMPLANT
- K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
- K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
- K061626 — VASORING* VRC VASCULAR RING CONNECTOR
- K061984 — TREASURE
- K062032 — ACCUSOFT, ACCUSOFT XL
- K062047 — ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES
- K062061 — URASSIST
- K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
- K062337 — MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR
- K062351 — SYNGO DUAL ENERGY
- K062360 — BRANSIST SAFIRE
- K062386 — QANGIO CT
- K062387 — SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
- K062516 — ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
- K062529 — BELMAX CM MODEL X168
- K062556 — ECHELON SHOULDER COIL
- K062680 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML
- K062686 — UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.