FDA 510(k) clearances — page 451
clearances on record, most recent first.
Clearances — page 451
45,001–45,100 of 175,770- K111689 — STLASE
- K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENT
- K111874 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
- K112271 — 3B WILLOW
- K112330 — KOWA VX-20
- K112680 — EVIS EXERA III VIDEO SYSTEM
- K112831 — PLEURX PLEURAL CATHETER SYSTEMS
- K112841 — SURFACE BEACON TRANSPONDERS
- K113419 — CS IMAGING
- K113442 — 3DI
- K113518 — ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
- K113526 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
- K113701 — VISIA NEURO
- K120121 — COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
- K120143 — ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
- K120337 — I-PORT ADVANCE INJECTION PORT
- K120392 — CHROMOPHARE F 628 AND F 528
- DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
- K110278 — CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
- K110748 — OLYMPUS INSTRUMENT TRAY
- K113378 — CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K113409 — S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
- K113721 — TEPHAFLEX LIGHT MESH
- K113723 — TEPHAFLEX MESH
- K113724 — ELECTROPULSE-COSMETIC
- K120140 — FOCUS SPINAL SYSTEM
- K111018 — POLYFUSE - NEUROBONE
- K111758 — CADENS (TM) COLON
- K111938 — IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
- K113390 — LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
- K113403 — GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
- K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
- K113551 — ESOPHAGEAL TTS STENT
- K113634 — INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
- K113710 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
- K113722 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
- K120132 — SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
- K120137 — VICTORY GUIDEWIRE (32 MODELS)
- K120144 — VITAL SIGNS MONITOR
- K111405 — BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
- K112595 — COFLEX-F
- K113406 — AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
- K103044 — AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
- K110078 — EXTRICARE
- K110623 — PILLAR PALATAL IMPLANT SYSTEM
- K112016 — L-SER KO LAMP
- K112042 — KINGYIELD WRIST BLOOD PRESSURE MONITOR
- K112888 — MESO WOUND MATRIX
- K112994 — CRE DITATATION BALLON
- K113259 — NOTOUCH BREASTSCAN
- K113305 — VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
- K113362 — SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
- K113542 — SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
- K113612 — AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
- K113697 — EIGR SURGICAL ILLUMINATION SYSTEM
- K120122 — SENSE MSK S 8CH 1.5T
- K120131 — REGIUS SIGMA2
- K120268 — AMID STAPLER
- K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS
- K112006 — HAMILTON-TC1
- K112407 — SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
- K112709 — STIMULATION/DISSECTION INSTRUMENTS
- K113104 — INTEGRA WOUND MATRIX (THIN)
- K113183 — PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
- K113250 — DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
- K113529 — CD HORIZON VOYAGER SPINAL SYSTEM
- K113772 — HPR EMOLLIENT FOAM
- K113774 — HPR PLUS EMOLLIENT FOAM
- K120212 — AFX INTRODUCER SYSTEM
- K103726 — JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
- K111249 — ORTHOSLENDERIZER
- K111937 — CLEARFLASH AC2100 COSMETIC SYSTEM
- K112542 — YOMURA SAFETY I.V. CATHETER
- K112723 — EPIGRAY
- K113343 — DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
- K113396 — DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
- K113426 — VERACIA SA
- K113600 — IM BAND
- K120083 — SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
- K120156 — PUREIMAGE ULTRASOUND TRANSMISSION GEL
- K120178 — WINGMAN EXTENDABLE TIP SUPPORT CATHETER
- K111678 — ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
- K112383 — CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
- K112541 — Z FLEX-270TM STEERABLE SHEATH
- K112591 — SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
- K112673 — PROPHY-MATE NEO
- K113021 — TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT
- K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS)
- K113360 — MEDICAL IMAGE PROCESSING UNIT
- K113401 — ORTHO-1(NOT FINALIZED)
- K111481 — CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS
- K111726 — PATHWAY AVID
- K111890 — FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
- K111959 — AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
- K112106 — NAVIAID ICVI-F,S,B,R DEVICE
- K112642 — AQUILEX FLUID CONTROL SYSTEM H112
- K113100 — POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K113196 — VASCULAR SONO
- K113319 — ROTOR-GENE Q MDX
- K113323 — ARTUS INFL A/B RG RT-PCR KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.