FDA 510(k) clearances — page 554
clearances on record, most recent first.
Clearances — page 554
55,301–55,400 of 176,542- K081645 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
- K081828 — ZOLL R SERIES BLS DEFIBRILLATOR
- K082297 — BUSSE SURGICAL DRAPE
- K082302 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
- K082308 — MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K082672 — NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
- K082700 — TEMPORARY COLD.V AND SELF-CURE DENTINE
- K082922 — FREEWAY AND RAILRUNNER GUIDEWIRES
- K083013 — PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
- K083472 — MEDEGEN PRESSURE RATED EXTENSION SETS
- K080499 — MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
- K082384 — HAV-LOK BUNION CORRECTION SYSTEM
- K082574 — MAXTORQUE MINI CANNULATED SCREW SYSTEM
- K082580 — SPECTRA GUIDEWIRE INTRODUCER NEEDLE
- K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY
- K080558 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
- K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
- K081073 — HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
- K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
- K081990 — LUBRICANO STERILE GEL
- K082001 — DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
- K082049 — LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
- K082591 — FLEXITIME BITE
- K082607 — MRI-PLAQUE VIEW, VERSION 1.1.2003
- K082893 — PRAGER SHELL
- K082913 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
- K082950 — STARBAND
- K082972 — KODAK 9500
- K083029 — MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
- K083086 — ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
- K083293 — VIATRONIX V3D-CARDIAC, REVISION 1.0
- K071849 — ALLOFUSE GEL AND PUTTY
- K072562 — MICROWARE BONE PLATES AND BONE SCREWS
- K080485 — ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
- K080903 — ZOLL E SERIES WITH INTIBATION ASSIST OPTION
- K081635 — INTEGRA MESHED BILAYER WOUND MATRIX
- K081697 — THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
- K081848 — LIPOSE FAT TRANSFER SYSTEM
- K081861 — HOLTER LX ANALYSIS
- K082169 — PRO GLUCOSE TEST STRIP
- K082387 — APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
- K082585 — DEPUY ASPHERE M-SPEC HEAD
- K082670 — MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
- K082749 — OMNI-TIGHT
- K082854 — NANOCORSS .014 OTW PTA DILATATION CATHETER
- K082935 — VISION WIRE CORONARY GUIDEWIRE
- K082962 — TIVAMED COOLED RF SYSTEM, MODEL 78001
- K083109 — SUINSA DIAGNOSTIC X-RAY SYSTEM
- K083343 — HEADWAY 17 MICROCATHETER
- K083454 — NUOVOCATH
- K081592 — POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
- K081739 — 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
- K082225 — 15W CERALAS D 1470NM DIODE LASER, MODEL D1470
- K082380 — VICARDIO 12B
- K082408 — LEDEX, MODEL: WL-070
- K082423 — NO!NO! SKIN
- K082566 — MARK 5 NUVO LITE OCSI AND STD
- K082786 — PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
- K083230 — MERCURY SPINAL SYSTEM
- K081786 — ZIOCERA & CONVERTIBLE SYSTEM
- K082539 — MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
- K082546 — REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
- K081977 — PROSIT WOUND TREATMENT DEVICE
- K082208 — DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
- K082456 — VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
- K082535 — COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
- K080241 — DDS STABILIZATION SYSTEM
- K080278 — TABATABA COTESTER
- K082011 — MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
- K082172 — MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
- K082540 — GE ENTROPY SENSOR
- K082674 — SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
- K080398 — SI JOINT FUSION SYSTEM
- K080446 — RAPIDVIT AND RAPIDWARM CLEAVE
- K080650 — OMNI-DL SYSTEM
- K081975 — RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
- K082541 — HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
- K082600 — OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
- K082602 — FETAL & MATERNAL MONITOR, MODEL F6, F9
- K082730 — AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
- K082740 — GC AADVA ZR DISK
- K082785 — NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
- K082888 — INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997
- K083039 — VERITAS COLLAGEN MATRIX (DRY)
- K083078 — QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200
- K083115 — MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
- K083181 — QV-9000 UNIVERSAL SYSTEM
- K083321 — CARDIO-VIEW
- K083340 — LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
- K072687 — VALLEYLAB MICROWAVE ABLATION GENERATOR
- K080467 — BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
- K080649 — POGO SCREW
- K081867 — MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
- K082153 — MAJOR.REPAIR
- K082200 — KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
- K082253 — BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
- K082358 — SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
- K082415 — PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
- K082575 — ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
- K082654 — ENTERAL ONLY EXTENSION SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.