FDA 510(k) clearances — page 495
clearances on record, most recent first.
Clearances — page 495
49,401–49,500 of 176,542- K101363 — VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
- K101413 — EUROMI EVA SP6
- K101558 — GNR TRAFFIC LIGHT PNA FISH
- K101659 — SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
- K101956 — STRAUMANN MEMBRAGEL
- K102029 — PEAK PULSAR II GENERATOR MODEL PS100-102
- K102084 — STIMPOD NMS450 NERVE STIMULATOR
- K102214 — ENDO FLIP
- K102249 — EXPEDIUM SPINE SYSTEM
- K102323 — CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
- K102341 — VIPI BLOCK
- K102419 — GSP NEONATAL IRT KIT (3306-001U)
- K102624 — AVITA WRIST TYPE BLOOD PRESSURE MONITOR
- K102755 — CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
- K102766 — COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
- K103147 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
- K103249 — NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
- K103408 — POSTERIOR LATERAL PLATES
- K103536 — IBED WIRELESS WITH IBED AWARENESS
- K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
- K100103 — SPECIALTY ASSAYED CONTROL-2
- K100525 — ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
- K100999 — IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01
- K101012 — V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
- K101118 — ACTIVON TULLE
- K101996 — DEPUY GLOBAL UNITE SHOULDER SYSTEM
- K102201 — CONTOURS LAPIDUS PLATING SYSTEM
- K102796 — ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
- K102956 — V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING
- K100372 — SAFECT MODEL VER 1.0
- K100780 — VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
- K102734 — COMFORT STANDING WHEELCHAIR, HERO SERIES
- K102907 — SIMMETRY SACROILIAC JOINT FUSION SYSTEM
- K103374 — INBONE TOTAL ANKLE SYSTEM MODEL 200347902
- K100205 — FRONTIER DEVICES NEURO SYSTEM
- K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
- K100779 — SUSTAIN SPACE MAINTENANCE SYSTEM
- K101465 — STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR
- K102061 — TREVAIR CHAIR ADULT
- K102660 — BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
- K102718 — DIGITAL THERMOMETER; DIGITAL THERMOMETER
- K102896 — TRABECULAR METAL TIBIAL CONE AUGMENTS
- K102976 — POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)
- K103419 — EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
- K103459 — VASCUTRAK PTA DILATATION CATHETER
- K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
- K100261 — PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
- K100777 — ABL837 FLEX ANALYZER
- K100858 — LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
- K101003 — RAPIDVIT BLAST, RAPIDWARM BLAST
- K101433 — DEPUY ATTUNE KNEE SYSTEM
- K101520 — ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
- K102166 — ELECTRO INTERSTITIAL SCAN
- K102187 — RII INFRARED EAR THERMOMETER,
- K102224 — PIXI PEDIATRIC MASK
- K102488 — APEX SPINE SYSTEM W/ COCR RODS
- K102537 — APTUS 1.5 TRILOCK
- K102618 — VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
- K102645 — WILLOW/ELM PTA BALLOON DILATATION CATHETER
- K102658 — MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
- K102749 — QUANTA CYBER TM 150W
- K103008 — INZONE DETACHMENT SYSTEM
- K103034 — GENESYS SPINE INTERBODY FUSION SYSTEM
- K103247 — VASCUCOMP
- K103311 — U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
- K103344 — INFUSION SETS
- K093491 — HIP SEXTANT INSTRUMENT SYSTEM
- K100854 — PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
- K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
- K101319 — IMMULISA DSDNA ANTIBODY ELISA
- K101609 — SELF RETAINING SOFT TISSUE RETRACTOR
- K102424 — PREVISION HIP SYSTEM WITH RECON RING
- K102436 — NOBEL ACTIVE 3.0
- K102473 — MULLINS-X PTV CATHETER
- K102609 — KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K102694 — 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
- K102723 — MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
- K102989 — OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
- K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K100668 — NEMA-ST, MODEL V1.0.2
- K101153 — QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
- K101910 — 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
- K102143 — SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
- K102367 — OPTIGEN TOTAL KNEE SYSTEM
- K102659 — MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
- K102739 — HYDROCOLOR 5
- K102965 — CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
- K102984 — AURA
- K103356 — PRUITT CAROTID KIT
- K103367 — SEEKER CROSSING SUPPORT CATHETER
- K100469 — ARCOS INTERLOCKING DISTAL STEMS
- K100709 — EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
- K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
- K101401 — NEUMOVENT GRAPHNET MODEL 3179L1V
- K101682 — S 100 PEDICLE SCREW SYSTEM
- K101806 — AIDERA DIASEND SYSTEM
- K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM
- K102095 — SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
- K102103 — SKELETAL DYNAMICS STERILIZATION TRAYS
- K102111 — MEDICAL MAGNETIC TAPE RECORDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.