FDA 510(k) clearances — page 495
clearances on record, most recent first.
Clearances — page 495
49,401–49,500 of 175,770- K094049 — STLASE DIODE LASER
- K100736 — KIRSCHNER AND GUIDE WIRES
- K101203 — TINA-QUANT ALBUMIN GEN 2
- K101288 — STAXX XD SYSTEM
- K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
- K101696 — MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
- K102004 — ENDEAVOUR MONITORING SYSTEM
- K102230 — NUGARD NITILE GREY COLOR
- K102267 — ELECSYS FERRITIN CALCHECK 5
- K102303 — BLOOD PRESSURE METER, MODEL CH-658
- K102430 — TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
- K102442 — E.S.O. (ELECTRO SENSOR OXI)
- K100853 — COBAS 8000 MODULAR SERIES ANALYZER
- K100985 — BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
- K101551 — PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
- K101885 — MEDTRONIC C315 DELIVERY CATHETER
- K093723 — EMS MINIMASTER LED
- K101249 — STERIGAGE MODEL 1243RA, 1243RB, 1243RE
- K101456 — ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
- K101490 — FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
- K101646 — NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
- K101694 — HANDHELD PULSE OXIMETER MODEL M800
- K101734 — VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
- K101803 — NEWPORT E360 VENTILATOR
- K102032 — KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
- K102118 — SNORE GUARD ADVANCE
- K100442 — FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
- K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
- K101630 — POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
- K101868 — INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
- K101883 — 6F ENGAGE/ENGAGE TR INTRODUCER
- K102273 — MERIT BIPOLAR COAGULATION PROBE
- K102368 — NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
- K091125 — CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
- K100418 — SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
- K100455 — SPAPLUS ANALYZER
- K100718 — AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
- K101054 — ROMIAPEX MODEL A-15
- K101086 — TAPERLOC COMPLETE
- K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
- K101550 — BIOGRAPH MCT FAMILY
- K101593 — EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
- K101799 — POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
- K101834 — 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
- K102011 — ECLIPSE TREATMENT PLANNING SYSTEM
- K102107 — OSSTAPLE CHILL
- K102211 — CRUISER 18 GUIDEWIRE
- K091969 — EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
- K092736 — EUROIMMUN ANTI-M2-3E ELISA (IGG)
- K093430 — EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
- K100243 — QUINTEX CERVICAL PLATING SYSTEM
- K100795 — JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
- K101034 — NIOX MINO MODEL 09-1000
- K101130 — BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
- K101310 — VU APOD INTERVERTEBRAL BODY FUSION DEVICE
- K101326 — NMI IC
- K101567 — SHARPS CONTAINER
- K102178 — EASY TOUCH
- K101506 — LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
- K101532 — NESSI OTC SPACER
- K101602 — VITAL SIGNS MONITOR
- K101860 — NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
- K102016 — PRECICONTROL CLINCHEM MULTI 1 AND 2
- K102020 — VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
- K102176 — FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
- K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE
- K093689 — 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
- K100102 — CS-SERIES-FP
- K100124 — FASTX STERNAL INTRAOSSEOUS DEVICE
- K100307 — GELSCAN, MODEL 1206
- K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
- K100749 — FREQUENCER MODEL V2X
- K101070 — EXPEDIUM SPINE SYSTEM
- K101226 — AUDIT MICROCV RF/CRP LINEARITY SET
- K101339 — ARCHER SUPER STIFF GUIDEWIRES
- K101600 — INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
- K101605 — MYLABONE ULTRASOUND SYSTEM
- K101714 — NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
- K101878 — GE LOGIQ P5 MODEL H44662LD
- K101950 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
- K102014 — TENS STIMULATOR, MODELS 2800 AND 3000
- K102044 — ELECSYS DIGOXIN CALCHECK 5
- K102155 — MR RADIATION ONCOLOGY OPTIONS
- K092449 — BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
- K093725 — CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
- K100055 — BLOOD PRESSURE METER, MODEL CH-609
- K100448 — ASCENSION MODULAR TOTAL SHOULDER SYSTEM
- K100998 — 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
- K101287 — TEPHAFLEX COMPOSITE MESH
- K101810 — 3DHJD CAMERA SYSTEM MODEL
- K102169 — CYBERWAND LITHOTRIPTER
- K093821 — FS ALIGNER
- K093963 — QUASAR BLUE LIGHT THERAPY SYSTEM
- K100141 — 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
- K100304 — ST AIA PACK HBA1C
- K100367 — MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229
- K100622 — BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
- K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
- K100763 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4
- K101196 — ACCU-CHEK ULTRFLEX INFUSION SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.