FDA 510(k) clearances — page 485
clearances on record, most recent first.
Clearances — page 485
48,401–48,500 of 176,542- K102212 — D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
- K102222 — ULTIMATE VIT ENHAMCER (UVE)
- K103083 — AGILIS ES STEERABLE INTRODUCER
- K103140 — NICOLET WIRELESS EEG
- K103298 — ACAM 5 AUDIOMETER SYSTEM
- K103549 — DENOVO TEDDY GEL INFANT HEEL WARMER
- K103600 — PORTABLE X-RAY SYSTEM
- K103672 — REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
- K103759 — ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
- K110067 — LP CAGE
- K110092 — TAKE 1 ADVANCED RIGID TRAY
- K110116 — XEROS DRY MOUTH PUMP
- K110117 — ATRICURE BIPOLAR SYSTEM
- K110127 — PRELUDE III TONGUE SUSPENSION SYSTEM
- K110138 — PAIRED HYDROGEL ELECTRODE
- K110147 — ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
- K110304 — APEX ER. YAG / IPL SYSTEM
- K110411 — ATAMA SYSTEM
- K110479 — ACUITY WHISPER VIEW GUIDE WIRES
- K110563 — PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
- K110667 — IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
- K110802 — A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
- K110814 — AMBIT TUNNELER
- K110920 — UF-760AG
- K102033 — COMBITRANS MONITORING SETS AND ACCESSORIES
- K102467 — UTA AND UHA
- K103318 — UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
- K110169 — DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
- K110173 — EMS AIR-FLOW MASTER PIEZON
- K110186 — SYNAPSE 3D LIVER ANALYSIS
- K110203 — XPERT C. DIFFICLE/EPI ASSAY
- K110270 — ACCULIF CAGE
- K110353 — MOUNTAINEER OCT SPINAL SYSTEM
- K110595 — 4D SONO-SCAN 1.0
- K110782 — XVAC
- K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
- K100669 — CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
- K102225 — ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
- K102542 — RESUSCI FLOW; RESUSCI FLOW 104
- K103326 — MULTIPLE BIOPSY SYSTEM
- K103368 — HAIRMAX LASERCOMB
- K103587 — DISPOSABLE BLLOD COLLECTION NEEDLE
- K103604 — ISA CO2, ISA AX+, ISA OR+
- K103654 — VELA XL
- K103680 — MICROLIFE DIGITAL UNDERARM THERMOMETER
- K110260 — NEWTOM 5G / NEWTOM 5G VERSION FP
- K110373 — TEMPOROMANIBULAR COIL 15
- K110494 — SYNGO MBF
- K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
- K110744 — PRONTOSAN WOUND IRRIGATION SOLUTION
- K100767 — TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
- K101057 — AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1
- K102552 — HEMOSIL LA POSITIVE CONTROL
- K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
- K103248 — INTEGRITY SPINAL CARE SYSTEM
- K103262 — QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
- K103370 — RT200
- K103626 — CUTERA GENESISPLUS LASER SYSTEM
- K110055 — REVERSE MEDICAL REFLEX GUIDE CATHETER
- K110178 — ESTELITE COLOR
- K110262 — SHARPS CONTAINER
- K110378 — IMPRESSION COMPOUND
- K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
- K102726 — CARDIOHELP SYSTEM
- K102990 — BRAINLAB KNEE
- K103366 — RT600
- K103369 — VAULT ALIF SYSTEM
- K103428 — THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
- K103617 — DIGITAL FOREHEAD THERMOMETER
- K103829 — KNEEALIGN SYSTEM
- K110185 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
- K110255 — SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
- K110483 — MODIFIED HD GUIDE CATHETER
- K100714 — CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
- K100724 — OSSEOTITE II MODEL XIFOSSXXX
- K101484 — COMPRESSYN BAND
- K101722 — ALYTE Y-MESH GRAFT
- K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
- K102948 — TORFLEX TRANSSEPTAL GUIDING SHEATH
- K103218 — STERRAD CHEMICAL INDICATOR STRIP
- K103219 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE
- K103595 — ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
- K110216 — EXPEDIUM SYSTEM, VIPER SYSTEM
- K110522 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K110542 — CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
- K110610 — 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
- K110708 — EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
- K110727 — HYLATOPICPLUS CREAM
- K110820 — VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
- DEN070014 — MANDOMETER III
- DEN100025 — WIDEXLINK IN CLEAR SERIES HEARING AIDS
- K101482 — EM-9000
- K101830 — ZMACHINE, MODEL DT-100
- K103339 — TDS ABUTMENT FOR FRIADENT XIVE
- K103498 — LAKONG ULTRASONIC SCALER
- K103499 — A SCOPE
- K103670 — NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
- K110058 — BPA-FREE PIT AND FISSURE SEALANT
- K110218 — INSPIRA AIR BALLOON DILATION SYSTEM
- K110622 — INTELLIVUE PATIENT MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.