FDA 510(k) clearances — page 580
clearances on record, most recent first.
Clearances — page 580
57,901–58,000 of 176,542- K080106 — SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
- K071646 — SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
- K072002 — FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
- K072363 — NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
- K072691 — CERVICAL MD, MODEL C10
- K072798 — VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
- K072920 — HANDHELD BASE UNIT
- K073171 — RESUSCITATION TIMER, MODEL L770-CPR
- K073530 — ACCIN ANTERIOR CERVICAL PLATE SYSTEM
- K073539 — PROVISA CEM
- K073559 — 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
- K073563 — MODIFICATION TO PROXIS SYSTEM
- K080121 — CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
- K080124 — VENTRI 1.1
- K070514 — ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO
- K071778 — HERO VASCULAR ACCESS DEVICE
- K072252 — VEINOPLUS NEUROMUSCULAR STIMULATOR
- K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
- K072381 — SOFTPAP CERVICAL CELL COLLECTOR
- K072538 — PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
- K072608 — LYOPHILIZED MULTIBLAST MEDIUM KIT
- K073004 — SOMNOMED BFLEX
- K073139 — SMALL LUMEN PERITONEAL CATHETER
- K073202 — ARDIS SPACER
- K073267 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K073413 — DEPUY ASR 300 ACETABULAR CUP SYSTEM
- K073573 — WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
- K073663 — GELSPRAY WOUND DRESSING
- K073703 — AMS MINIARC SLING SYSTEM
- K073707 — GE DATEX-OHMEDA AISYS
- K062534 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
- K072760 — SOLCART B
- K073092 — DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
- K073135 — SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
- K073209 — MAXCEM 2
- K073275 — NUVASIVE HELIX MINI ACP SYSTEM
- K073430 — VALEO PEDICLE SCREW SPINAL SYSTEM
- K073676 — DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP
- K073719 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE
- K080019 — HARDYDISK AST DORIPENEM 10 UG
- K072114 — IMPULSE 6000D/7000DP
- K072943 — BUTREX BUTTRESS PLATING SYSTEM
- K072967 — QUANTA LITE F-ACTIN IGA ELISA
- K072989 — AXIS SYSTEM
- K073233 — ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
- K073655 — PEGASUS STEERABLE (PTCA) GUIDEWIRE
- K073701 — DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000
- K080026 — QUANTUM-MIS CANNULATED SYSTEM
- K080075 — MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
- K071734 — WATERLASE MD DERM
- K072174 — INSUCOZI INSULIN VIAL COVER
- K072238 — BIOSET XCH
- K072415 — STALIF (TM) C
- K072607 — LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
- K072647 — GLYCERIN & PARABEN FREE ASTROGLIDE
- K072753 — REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
- K072754 — AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
- K072887 — G-TRAINER MEDICAL
- K073050 — SAFESTEP MAX POWER-INJECTABLE INFUSION SET
- K073069 — MODIFICATION TO AVEA VENTILATOR
- K073257 — KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR
- K073461 — ORTHO ANCHOR SCREWS
- K073625 — MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
- K073649 — BENGAL STACKABLE CAGE SYSTEM
- K073656 — OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
- K073665 — ALGO 5 NEWBORN HEARING SCREENER
- K073670 — KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
- K073683 — VERIFY CHALLENGE PACKS - VERSION 2
- K071240 — IMPLASA-HOECHST GMBH IMPLANTS
- K072166 — CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
- K072596 — LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
- K072653 — 3VISEON/SURGERY
- K072777 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
- K072779 — CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
- K072806 — MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
- K072833 — P-NAIN SYSTEM
- K072969 — DSS
- K073039 — SPERMCHECK VASECTOMY
- K073080 — QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
- K073144 — LANX INTERVERTEBRAL BODY FUSION DEVICE
- K073351 — CRYSTAL
- K073441 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
- K073529 — DEPUY SIGMA PS FEMORAL COMPONENTS
- K073654 — BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
- K073672 — SKATER BILIARY CATHETER
- K080024 — ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
- K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
- K071774 — JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
- K071883 — IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2
- K072906 — SILK'N
- K073014 — INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
- K073018 — STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT
- K073173 — SELF-ADHESIVE RESIN CEMENT
- K073406 — VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
- K073464 — ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT
- K073496 — OPTILITE HOLMIUM LASER FIBERS
- K073503 — VERSA LITE
- K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
- K080049 — VASCUVIEW ULTRASOUND SYSTEM
- K080064 — FLAATZ 750
Data sourced from openFDA. This site is unofficial and independent of the FDA.