FDA 510(k) clearances — page 479
clearances on record, most recent first.
Clearances — page 479
47,801–47,900 of 176,542- 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
- 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
- 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
- K100313 — HYDROFIX SURGICAL SHEET
- K110001 — SPACELABS PATHFINDER SL HOLTER ANALYZER
- K110597 — EV1000 CLINICAL PLATFORM
- K110599 — AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
- K110739 — ENTELLUS MEDICAL SINUS GUIDEWIRE
- K110747 — TEMPFLEX
- K111078 — AEU-26L ELCTRONIC ENDODONTIC SYSTEM
- K111217 — ADDITIVE CAP
- K111244 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
- K101990 — ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
- K102458 — 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
- K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
- K110374 — MAX PULSE SYSTEM
- K110927 — MECTALIF
- K110933 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
- K102258 — CUSA NXT EXTENDED LENGTH TIP
- K102389 — NAVIGATOR APPLICATIONS SUITE
- K102625 — VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
- K103584 — ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
- K103601 — AUDIT MICROCV IMMUNOASSAY LINEARITY SET
- K103736 — DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
- K110088 — DEFENDO Y-OPSY IRRIGATOR
- K110119 — PRESSURE MANOMETER
- K110133 — EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
- K110247 — POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K110248 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
- K110274 — AUTODELFIA NEONATAL IRT KIT
- K110356 — ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.