FDA 510(k) clearances — page 446
clearances on record, most recent first.
Clearances — page 446
44,501–44,600 of 175,770- K112305 — VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES
- K112928 — RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
- K113424 — LOFRIC SINGLE USE URINARY CATHETER
- K113593 — NEXTGEN ALTIUS OCT SYSTEM
- K120028 — AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
- K120034 — RADIOGRAPHIC X-RAY SYSTEM
- K120165 — INTRAOSSEOUS FIXATION SYSTEM
- K120367 — 3MENSIO WORKSTATION
- K120591 — DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
- K120816 — INZONE DETACHMENT SYSTEM
- K120850 — TARGET DETACHABLE COIL
- K121001 — COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
- K103767 — DUAL HEATED INFANT VREATHING CIROUITS
- K112290 — SUPERCATH Z3V
- K113352 — TRANSCORP SPINAL ACCESS SYSTEM
- K113802 — ESCALATE LAMINOPLASTY SYSTEM
- K120117 — CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
- K120291 — OP SPINE SYSTEM
- K120403 — SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
- K120830 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K102327 — CLEARVISION DR 7000F
- K110590 — INTRABEAM NEEDLE APPLICATOR
- K112141 — SMARTEPIL,DEPILASE YAG LASE PLUS
- K112717 — NUVASIVE NVJJB SYSTEM
- K113096 — MICRO I
- K120032 — MECHANICAL WHEELCHAIR
- K120062 — DRX-REVOLUTION MOBILE X-RAY SYSTEM
- K120092 — PLYMOUTH THORACOLUMBAR PLATE SYSTEM
- K120135 — 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
- K120161 — ALPHAPOINT IMAGING SOFTWARE
- K120292 — CAPLOX II PEDICLE SCREW SYSTEM
- K120300 — CT-GUIDE NEEDLE GUIDANCE SYSTEM
- K120315 — SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
- K120331 — SYNGO CT DYNAMIC ANGIO
- K120703 — ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
- K120794 — ASCEND SHOULDER SYSTEM
- K120805 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
- K120972 — FLEXITOUCH SYSTEM
- K110333 — NATURALASE CO2 LASER SYSTEM
- K111050 — ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
- K111547 — BILI-THERAPY PAD TYPE
- K112215 — HEMCON HEMOSTATIC GEL
- K112398 — TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
- K113186 — STERILE INSULIN PEN NEEDLE
- K113583 — CURAD ANTIBACTERIAL BANDAGE
- K113768 — U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
- K113839 — RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
- K120209 — PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
- K103227 — ORATECT ORAL FLUID DRUG SCREEN DEVICES
- K112073 — INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
- K112438 — TITAN MODULAR TOTAL SHOULDER SYSTEM
- K113533 — NEURO CHECK DEVICE WITH IO-FLEX WIRE
- K113847 — BORRELIA BURGDORFERI IGG BLOT TEST
- K120252 — RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
- K120264 — KONAN SPECULAR MICROSCOPE XIV
- K111924 — FINESSE PERSONAL INSULIN DELIVERY PATCH
- K112110 — STERILE LUBRICATING JELLY
- K112989 — AQUILION CXL
- K113466 — AQUILION ONE
- K113548 — PEDCAT
- K113608 — DEFLEX
- K120157 — MINI MAXLOCK EXTREME PLATING SYSTEM
- K120390 — SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
- K120774 — ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
- K112149 — WEIGHT AND BODY FAT SCALE SHINE BS0105
- K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
- K112653 — ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
- K120349 — SONIXGPS VASCULAR ACCESS NEEDLE KIT
- K120368 — CAPSTONE CONTROL SPINAL SYSTEM
- K120473 — PIXEL APP
- K120477 — AEROSYNC FOR AERODR SYSTEM
- K111997 — IMAGE1 GI CCU MODEL 22203020-114
- K112505 — ETHEREA
- K112899 — ARTHREX BIO-SUTURE
- K113170 — CERVICAL PLATE
- K113463 — POWER WHEELCHAIR
- K120095 — SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
- K120187 — MULTI-MODALITY IMAGE FUSION
- K120279 — NANOFUSE DBM
- K120361 — SYNAPSE 3D BASE TOOLS
- K120387 — RAYSTATION
- K120388 — INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- K120448 — MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
- K120613 — OEC 9900 ELITE
- K120709 — THE DOME GX4MP COLOR NONITOR
- K120710 — AQUILION PRIME
- K120721 — EOS
- K110481 — TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
- K111453 — STEAM DOT BLU PROCESS INDICATOR
- K112470 — 2GC HIP/KNEE MODULAR SPACER
- K113502 — ADVANTAGE LASER SYSTEM
- K113554 — CMI IMPLANT IS SYSTEM
- K113626 — INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
- K113640 — STELLAR 150
- K113674 — SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT
- K113677 — GRINDCARE MEASURE
- K120003 — NUCAL
- K120570 — CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
- K120697 — EAGLE EYE PLATINUM ST CATHETER
- K120828 — BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
Data sourced from openFDA. This site is unofficial and independent of the FDA.