FDA 510(k) clearances — page 772
clearances on record, most recent first.
Clearances — page 772
77,101–77,200 of 176,637- K020319 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
- K020387 — MYALLERGYTEST SYSTEM
- K020432 — PULPDENT GLAZE
- K020481 — PULPDENT POST CEMENT
- K020506 — MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)
- K020813 — BACT/ALERT FA CULTURE BOTTLE
- K020858 — NXSTAGE THERAPY SYSTEM
- K020864 — EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
- K020890 — SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
- K020940 — SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
- K020947 — MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
- K020955 — NICOLET ELECTROCAUTERY DETECTOR
- K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
- K021077 — MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
- K021139 — TRULINE REINFORCED VALVED INFUSION CATHETER
- K013300 — MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
- K013621 — BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
- K013637 — ACTICHROME HEPARIN (ANTI-FIIA)
- K020152 — SYNTHES VERTEBRAL SPACER TI
- K020468 — CHIN ELECTRODE
- K020528 — INTRASTENT LD (LARGE DIAMETER) STENT
- K020740 — ROCHE ONLINE THEOPHYLLINE
- K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
- K020963 — TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
- K021046 — COBRA COOLED SURGICAL PROBE, MODEL 1596X
- K021076 — PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
- K003916 — DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
- K020134 — SPIRAL RADIUS 90-D RODDING SYSTEM
- K020145 — ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
- K020146 — SERRALNYL
- K020153 — CONSENSUS ACETABLAR SHELL, TI COATED
- K020325 — L.A.M. IPM WOUND GEL
- K020435 — WOUND PROTECTOR/RETRACTOR
- K020488 — CARESIDE TRGLYCERIDE
- K020517 — SYNTHES DUAL-OPENING USS
- K020878 — LYPHOCHEK HEMOSTASIS, MODELS 798, 799
- K020905 — NBX - NON-BRIDGING EXTERNAL FIXATOR
- K011903 — LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
- K012650 — HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
- K012651 — HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
- K012654 — HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40
- K012657 — HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
- K020135 — CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120
- K020186 — CONMED SYSTEM 5000 ESU
- K020219 — RPI SKIN OR AIR TEMPERATURE PROBE
- K020276 — 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
- K020287 — DENTITION INTEGRATING MATERIAL
- K020330 — DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)
- K020394 — APC PLUS ADHESIVE
- K020447 — MITYVAC MERLIN, MODEL 10027
- K020448 — STATIC CRANIOPLASTY ORTHOSIS
- K020496 — HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY
- K020575 — ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
- K020662 — MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
- K020697 — DEPILASE TWIN YAG LASER SYSTEM
- K020809 — MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
- K020817 — LIQUICHEK URINE CHEMISTRY CONTROL
- K020824 — SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
- K020995 — EFILM WORKSTATION WITH MODULES
- K021029 — ABP-2000 G-3
- K002578 — AXILLARY ACCESS ARTERIAL CANNULA
- K011068 — RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
- K011541 — ZOLL PAD WITH CPR AID
- K012956 — HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
- K013160 — POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
- K020099 — MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
- K020206 — INTRAORAL CAMERA ME-15
- K020841 — AVON PATELLAR COMPONENT
- K020854 — MODIFICATION TO FOX PTA CATHETER
- K011524 — IMMEDIATE STABILIZING DEVICE (ISD)
- K020089 — MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
- K020106 — VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
- K020151 — UD-1000 ULTRASONIC A/B SCANNER
- K020343 — SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL
- K020363 — GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
- K020396 — BIOCELLECT -PERIO
- K020912 — SIMPLICITY EASY SOFT INFUSION SET
- K020990 — SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
- K010281 — MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
- K012325 — CARDIOVENTION CORX SYSTEM, MODEL FG 0001
- K012758 — URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
- K013067 — FRIALOC DENTAL IMPLANT SYSTEM
- K013349 — ASTRONOMER PLUS SYSTEM
- K014025 — HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
- K020072 — ATHOS LASER
- K020139 — FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
- K020376 — AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
- K020654 — STRATASIS SLING KIT
- K020832 — ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
- K021052 — MODEL GT010706 ELECTRONIC THERMOMETER
- K012226 — MONITORING SYSTEM,MODEL ARGUS PB-1000
- K012417 — HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480
- K012803 — AL-2000 COMBINED BIOMETER AND PACHYMETER
- K013672 — BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
- K013848 — U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
- K020176 — HDR MIAMI APPLICATOR
- K020327 — SURGIC IV IMPLANT CONTROL UNIT
- K020454 — CHEMISTRY CALIBRATOR
- K021028 — MODEL GT980201 ELECTRONIC THERMOMETER
- K013253 — HISONIC-TRD TINNITUS RELIEF DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.