FDA 510(k) clearances — page 527
clearances on record, most recent first.
Clearances — page 527
52,601–52,700 of 176,542- K092292 — CHECKPOINT
- K092926 — ACELL MATRISTEM WOUND SHEET
- K093002 — AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
- K090055 — LOW & HIGH SPEED KIT
- K090139 — ANKLE ARTHRODESIS PLATE SYSTEM
- K091064 — NAVILAS LASER SYSTEM
- K091174 — VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL
- K091196 — GRS GLENOID RESURFACING SYSTEM
- K091446 — MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
- K091915 — FLUID ISOLATION DEVICE
- K092150 — COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
- K092281 — CLEARFIL MAJESTY POSTERIOR PLT
- K092303 — MERIT LAUREATE HYDROPHILIC GUIDE WIRE
- K092381 — IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION
- K092873 — REVERSE SHOULDER PROSTHESIS
- K092986 — ACACIA PISTON SYRINGE
- K083077 — ULC SPINAL PEDICLE SCREW SYSTEM
- K091000 — KNEEKG
- K091413 — S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
- K091696 — SAVI WIRELESS, MODEL PM500
- K092544 — INSTRUMED VASCULAR CLAMPS
- K093058 — TSRH SPINAL SYSTEM
- K082207 — ORTHOCAD IQ
- K090542 — SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
- K090641 — CURIOS
- K090751 — COMET ANTERIOR CERVICAL PLATE SYSTEM
- K090897 — TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
- K091100 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K091102 — ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
- K091191 — GAS TRANSFILL
- K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000
- K091305 — CLEARPATH
- K091606 — VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
- K091871 — DK50 DS
- K091935 — LIPIVIEW OCULAR SURFACE INTERFEROMETER
- K092418 — ENTRACARE GASTROSTOMY FEEDING TUBE
- K092443 — INTERFACE ACETABULAR CUP LINERS
- K092456 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
- K092919 — MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
- K092961 — JAZZY FRONTIE
- K092990 — AMD 6605 TENS/NMES
- K093183 — BIS QUATRO SENSOR
- K090823 — THERAFORM BILAYER
- K091389 — EQUALSHIELD LUER LOCK CONNECTOR PAIR
- K091499 — MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
- K092010 — PC ECG, MODEL SE-1010
- K092301 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
- K092630 — ZIROX
- K092783 — DEBP
- K082756 — RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
- K090866 — NEUROCALM MODEL 1 AND 2
- K091354 — ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
- K091414 — VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
- K092101 — REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
- K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
- K092294 — VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
- K092296 — POWDER FREE EXAMINATION GLOVE
- K092411 — PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
- K092425 — REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
- K092492 — POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
- K092604 — LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX
- K092616 — ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
- K092824 — N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
- K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
- K092887 — EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
- K092957 — VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
- K093116 — MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
- K082891 — LENSTAR, MODEL LS900
- K083163 — OMNI 2 OXYGEN SYSTEM
- K090703 — POLY-CHEM 90 GLUCOSE
- K091542 — ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
- K091777 — ALCON ULTRACHOPPER
- K092221 — COLONIC SPLINTING OVERTUBE, MODEL 00711145
- K092289 — EMS AIR-FLOW HANDY PERIO
- K092561 — REJUVENATE MODULAR STEM
- K083626 — DISTRACTABLE WAVE CAGE
- K090474 — ORTHOREX INTRA-OPERATIVE LOAD SENSOR
- K090487 — DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
- K092034 — POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
- K092895 — APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- K092898 — CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
- K081265 — THAI NIPPON MALE LATEX CONDOM
- K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
- K091065 — AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
- K091516 — WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
- K091780 — GUIDED MEASUREMENT CATHETER (GMC)
- K091781 — GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
- K091833 — GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
- K091846 — SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
- K091848 — NOBEL/PROCERA IMPLANT BRIDGE
- K092039 — IDENTEVENT, VERSION 1.0G
- K092280 — CYPHER DICOM PRINT SOLUTION
- K092337 — PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
- K092570 — ABX PENTRA TPU CAL, MODEL A11A01898
- K092876 — SJM ATTUNE ANNULOPLASTY RING
- K092879 — LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER
- K092913 — EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
- K090006 — LIFEBRIDGE B2T, MODEL 7001
- K090008 — TANDA RESTORE, MODEL PTSCS
- K091458 — HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
Data sourced from openFDA. This site is unofficial and independent of the FDA.