FDA 510(k) clearances — page 806
clearances on record, most recent first.
Clearances — page 806
80,501–80,600 of 175,825- K003526 — SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)
- K003529 — SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
- K003567 — SERENOCEM, MODEL BC 010
- K003571 — SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
- K003668 — AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
- K003767 — ASSERACHROM HPIA TEST KIT
- K003829 — TOTAL BILIRUBIN
- K003858 — MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
- K010189 — VORTEX ACCESS SYSTEM
- K010304 — MXR-2000 MOBILE X-RAY UNIT
- K003493 — 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
- K003499 — REMVIEW SLEEP RECORDER, MODEL 320
- K003540 — (DISPOSABLE) VAGINAL SPECULUM
- K003743 — SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
- K003800 — AML HIP PROSTHESIS
- K003985 — POWDERFREE NITRILE PATIENT EXMINATION GLOVE
- K010044 — COSMIC
- K010095 — NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR
- K010102 — SONIC MODEL SO-300
- K010120 — MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
- K010121 — STERILE BUTTON PLATE
- K010150 — 64 CHANNEL EEG / MODEL NUMBER EX-NW-64
- K010179 — EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
- K010231 — JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
- K010282 — LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
- K993856 — TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
- K000943 — CEMEX SYSTEM GUN APPLICATION VERSION
- K002068 — ORG-9200A
- K002712 — THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
- K003496 — CANNULATED SCREW SYSTEM
- K003512 — LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
- K003535 — STYLET KIT, MODELS 6254,6282,6293
- K003586 — FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
- K003627 — EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
- K003641 — BIOLOK SCREW, BIOSTEON SCREW
- K003666 — TAPER-FIT TOTAL HIP SYSTEM
- K003843 — ENVIVE MINIFORMS
- K003940 — 2010 PLUS HOLTER FOR WINDOWS
- K010068 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
- K010190 — WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
- K010241 — PROTRACT PRESS FIT HIP STEM-HA COATED
- K000776 — MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
- K002469 — IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
- K002910 — HOLY DRAGON ACUPUNCTURE NEEDLES
- K003041 — ULTRASOUND SCANNER TYPE 2101
- K003338 — BIO-EYE II ORBITAL IMPLANT
- K003495 — ANCURE LLIAC BALLOON CATHETER
- K003533 — CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
- K003604 — ADAPTERS WITH X-COATING
- K003757 — THERMOFX MESH
- K010064 — 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
- K010066 — 5C-ES CELL CONTROL, MODELS 7547191, 7547192
- K010130 — POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
- K003293 — EXCITE DSC
- K003383 — PALMLIGHT
- K003760 — TAI-CHI ACUPUNCTURE NEEDLES
- K003958 — COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
- K004048 — SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K010238 — ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
- K010247 — SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
- K001781 — CURRY MULTIMODAL NEUROIMAGING SOFTWARE
- K001988 — MODULAR
- K002201 — ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
- K002280 — PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
- K002585 — RANDOX TRANSFERRIN
- K002642 — MINIQUANT D-DIMER, MODEL 1447
- K002877 — MICTEC ENDOSCOPES AND ACCESSORIES
- K003478 — TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
- K003597 — IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
- K003704 — OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
- K003796 — ADVIA 120 HEMATOLOGY
- K003854 — INTRAVASCULAR ADMINISTRATION SET
- K010001 — LIVESURE THC SCREEN TEST
- K010050 — ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
- K010081 — ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
- K993600 — MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
- K001965 — SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
- K002075 — ACE SDS 3.75MM SCREW DENTAL IMPLANT
- K002219 — WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
- K002227 — WANDY SILICONE CONDUCTIVE RUBBER PAD
- K002237 — P3IMRT TM
- K002407 — EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
- K002429 — SELECT SEED I-125
- K003436 — SURGI-VISION GUIDEWIRE COIL
- K003437 — ODYSSEY LX, MODEL 211320
- K003489 — NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8
- K003636 — PORTALVISION
- K003655 — PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
- K003710 — DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
- K003773 — CLEAN SCRAPE
- K003945 — OPDIMA
- K004037 — X-RAY SYSTEM XR-MX
- K010057 — MODIFICATION TO ARTOSCAN M
- K993229 — ANALGESIC PULSER, MODEL AP-439
- K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
- K002688 — PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
- K003425 — CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
- K003443 — SUCTION IRRIGATOR
- K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
- K003482 — PROCLUDE-SENSITIVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.