FDA 510(k) clearances — page 471
clearances on record, most recent first.
Clearances — page 471
47,001–47,100 of 175,770- K110712 — DRYTOUCH SUCTION STIMULATOR PROBE
- K110752 — HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
- K110908 — APTUS FOOT 3.5 SYSTEM
- K111063 — VITAL SERUM CONTROLS
- K111180 — VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
- K111340 — HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
- K111658 — AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
- K101509 — U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
- K110950 — CONSENSUS KNEE SYSTEM
- K110968 — PROFLU+ ASSAY
- K111193 — APEX ARC HIP STEM
- K102771 — BIOPSY HANDY, MRI BIOPSY HANDY
- K103520 — CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
- K110344 — INOMAX DSIR (DELIVERY SYSTEM)
- K110459 — SUREFIRE INFUSION CATHETER SYSTEM
- K110518 — IBAG
- K110545 — SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
- K110566 — VIBERECT PENILE VIBRATORY STIMULATION DEVICE
- K110609 — EPIDUCER LEAD DELIVERY SYSTEM
- K110630 — F10
- K110684 — MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
- K110704 — SENSI
- K110730 — MONACO RTP SYSTEM
- K110900 — DISPOSABLE THYROID COLLAR
- K111091 — MERIT MEDICAL 20 ML SYRINGE
- K111096 — VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
- K111133 — NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
- K111233 — SUPRIS RETROPUBIC SLING SYSTEM
- K111513 — CX50 DIAGNOSTIC ULTRASOUND SYSTEM
- K111638 — IMPAX VOLUME VIEWING
- K100716 — AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
- K101049 — WART FREEZE
- K102412 — VISTA DIGITAL OPTHALMOSCOPE
- K103562 — CENTURION PRESSURE INJECTABLE EXTENSION SET
- K110239 — LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
- K110306 — SOUND SURGICAL VASER 2.1 LIPO SYSTEM
- K110500 — STAT-MAT MINOR
- K110635 — INOMAX DS(IR) (DELIVERY SYSTEM)
- K110724 — SURGICAL PROCEDURE PACKS
- K110826 — CUROS PORT PROTECTOR
- K110859 — METAL OPAQUER
- K110930 — ACTIVE WASTE GAS SCAVENGER
- K111581 — 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE
- K111657 — AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
- K102942 — CORELEADER ALGIPLASTER MODEL AP 050501
- K102954 — CUTERA QSWITCH LASER SYSTEM
- K103456 — THE SENSITITRE AIM
- K110647 — RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
- K110843 — ALEUTIAN SPACER SYSTEM
- K110907 — PALOMAR ICON (TM) AESTHETIC SYSTEM
- K111073 — SURGIVISION INC. CLEARPOINT SYSTEM
- K111138 — THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
- K111184 — APEX PS KNEE SYSTEM - PS-C INSERT
- K111394 — MICROSCAN MICROSTEP
- K111444 — UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
- K101005 — ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
- K102345 — EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
- K103698 — TENSCARE ITOUCH SURE MODEL ITS
- K110414 — QLAB 8.1 QUANTIFICATION SOFTWARE
- K110805 — GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
- K110810 — ANASCIENT BREATH MONITOR
- K110812 — CT-GUIDE NEEDLE GUIDANCE SYSTEM
- K110830 — ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
- K110831 — SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
- K110946 — ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
- K103061 — BIOMATE STERILE ACUPUNCTURE NEEDLE
- K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
- K110509 — EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
- K110889 — IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
- K110980 — CENTRIMAG RETURN CANNULA KIT
- K110983 — CENTRIMAG DRAINAGE CANNULA KIT
- K111410 — NUVASIVE LONG LATERAL SPINAL SYSTEM
- K102917 — FIXTEMP C&B
- K110194 — MEDLINE EPIDURAL AND SPINAL NEEDLES
- K110291 — NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
- K110625 — SAFETYMATE TALKING FIRST AID
- K110823 — PRISMAFLEX
- K110871 — FIT CHECKER ADVANCED
- K111086 — ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
- K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
- K101641 — AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
- K103476 — BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
- K103641 — GUARDACARE
- K103713 — ELTA WOUND CLEANSER
- K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
- K110636 — TULA IONTOPHORESIS SYSTEM
- K110947 — APEX K1 HIP STEM
- K111100 — ENCOR ENSPIRE BREAST BIOPSY SYSTEM
- K111297 — SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
- K111459 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
- K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
- K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
- K102949 — COLONOSCOPY ASSISTANT
- K103594 — PONTO PRO POWER
- K110171 — NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
- K110297 — POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
- K110864 — BIOSPINE VBR SYSTEM
- K110953 — VISENSIA, VISENSIA WITH ALERT
- K111237 — MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY
- K111307 — AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
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