FDA 510(k) clearances — page 488
clearances on record, most recent first.
Clearances — page 488
48,701–48,800 of 176,542- K103335 — GEM OPTION FOR 1.5 MRI SYSTEMS
- K103400 — FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
- K103480 — THORACIC VCAR
- K092622 — STERRAD 100NX STERILIZER EXPRESS CYCLE
- K093584 — EZ-MISTER
- K102229 — PULMOTRACK 2020 SYSTEM
- K102320 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
- K102464 — QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
- K102474 — FLAATZ 750E
- K102610 — FOCUS EMG DEVICE
- K102642 — SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO
- K103127 — SOMATOM DEFINITION AS
- K103206 — RAUMEDIC- ICP-MONITORING SYSTEM
- K103292 — TRIO TRAUMA SPINAL SYSTEM
- K103458 — VIEWPOINT 6
- K103497 — CERAMIC FEMORAL HEAD
- K103585 — BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
- K103682 — PARIETEX PROGRIP
- K103687 — SYNAPSE 3D CEREBRAL ANALYSIS
- K103792 — BARCO MAMMO TOMOSYNTHESIS
- K110145 — BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
- K110322 — OLECRA INTRAMEDULLARY FIXATION SYSTEM
- K110354 — 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
- K110393 — EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
- K093830 — MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
- K101820 — NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
- K102019 — RESTORATION ACETABULAR WEDGE AUGMENTS
- K102403 — SAM CHEST SEAL WITH VAVLE
- K102554 — AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
- K102580 — VANGUARD REMOVABLE MOLDED POLY TIBIA
- K102636 — ZENITH PEDICLE SYSTEM
- K102912 — INTERLOCK FIBERED IDC OCCLUSION SYSTEM
- K103126 — TROPHON CHEMICAL INDICATOR
- K103142 — SPACELABS MULTI-PARAMETER MODULE
- K103477 — PERMOBIL M300 / M400
- K103679 — AXIS PACS, HMS PACS
- K103750 — NUVASIVE TRAVERSE PLATE SYSTEM
- K110295 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
- K101850 — SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
- K102825 — BLOOD PRESSURE CUFF
- K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
- K103488 — CONCORDE BULLET CAGE SYSTEM
- K103613 — INPECTRA STO2 SPOT CHECK
- K103741 — SURGISURE TISSUE REMOVAL SYSTEM
- K103748 — LAGUNA PEDICLE SCREW SYSTEM
- K110065 — SPAULDING IQ ELECTROCARDIOGRAPH
- K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
- K091010 — TROKAMED MORCELLATOR
- K092275 — RANDOX ECSTASY (MDMA) ASSAY
- K101569 — V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
- K101876 — DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
- K102172 — MSA HIP SYSTEM
- K103167 — STELLAR 150
- K103647 — THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
- K102397 — KYPHON XPEDE BONE CEMENT
- K103120 — CORIN BIOLOX DELTA FEMORAL HEADS
- K103399 — GENERAL DENISTRY MOTOR
- K103660 — LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
- K103840 — CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
- K110047 — VERTICOR K-WIRE SYSTEM
- K110362 — VANGUARD ASYMMETRICAL PATELLAR COMPONENT
- K092755 — STERRAAD 100NX EXPRESS CYCLE TEST PACK
- K093884 — ROCHE FLUDI METHAMPHETAMINE
- K100799 — FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
- K100954 — ADAPT, MODEL AX-03SN
- K102223 — CHALLENGE-EVER
- K102375 — LUCIA
- K102482 — FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM
- K102532 — HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
- K102947 — NON-CONTACT INFRARED THERMOMETER
- K103004 — SNORE GUARD
- K103185 — TOSHIBA 1.5T EXTRA LARGE KNEE COIL
- K103222 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K103337 — MULTIPLE NAME
- K103397 — ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
- K103449 — BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
- K103528 — IPS EMPRESS DIRECT FLOW
- K103772 — VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
- K110120 — ECHELON RAPID CARDIAC COIL
- K110163 — APPROACH PRO ST WIRE GUIDE
- K110241 — ENDOLOGIX GUIDEWIRE
- K110428 — ESCOM 100
- K090414 — SPECTRASHIELD 9500 SURGICAL MASK
- K101708 — PATIENT SAFE LUER CAP
- K101797 — SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T
- K102539 — ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
- K102597 — PICCOLO COMPOSITE PLATE SYSTEM
- K103059 — TROPHON
- K103119 — BILLY BOY MALE LATEX CONDOM
- K103253 — SILS PORT
- K103280 — BHDENTAL IMPLANT SYSTEM
- K103478 — SINGLE USE BILIARY DRAINAGE STENT V
- K103535 — VACPLUS SUCTION UNIT
- K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- K110080 — RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
- K110193 — FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER
- DEN110001 — RIDASCREEN NOROVIRUS 3RD GENERATION EIA
- K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
- K101732 — ASTRA TECH IMPLANT SYSTEM
- K102125 — PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
Data sourced from openFDA. This site is unofficial and independent of the FDA.