FDA 510(k) clearances — page 476
clearances on record, most recent first.
Clearances — page 476
47,501–47,600 of 176,542- K111067 — JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
- K111253 — ARTHREX DISTAL EXTREMITY PLATE SYSTEM
- K111288 — ANCHORWIRE GUIDEWIRE
- K111675 — VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
- K101572 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K102400 — SYPHILIS HEALTH CHECK
- K110383 — BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
- K110653 — CURE CATHETER
- K110958 — VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
- K111160 — INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
- K111334 — BENELLI ACCESS DEVICE
- K111395 — PRIMEWIRE PRESTIGE PLUS
- K111431 — B1P ADHESIVE
- K111686 — A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS
- K111745 — KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
- K111808 — SONOLITH I-MOVE
- K102051 — PAIN BUDDY
- K103220 — VOYAGER PERITONEAL DIALYSIS SYSTEM
- K103740 — SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
- K103830 — JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
- K110376 — PE-210AK SWITCH BOX
- K110390 — ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
- K110548 — OSI O-BALL ABUTMENT HEAD IMPLANTS
- K110600 — COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
- K110778 — BIODENTA CUSTOMIZED ABUTMENT
- K111245 — HEARTNAVIGATOR RELEASE 1
- K111424 — VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
- K111529 — MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-
- K111556 — GLIDECROSS SUPPORT CATHETER
- K111611 — ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
- K111870 — AMSCO WARMING CABINET
- K111884 — OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
- K111906 — XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
- K102528 — N-FORCE FIXATION SYSTEM
- K103130 — XELIS 3D
- K103574 — PREGNANCY ONE STEP RAPID TEST
- K110261 — ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
- K110419 — AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
- K110571 — TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
- K110631 — VENNER TRACHEAL SEAL MONITOR
- K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
- K110789 — SYNTHES STERNAL ZIPFIX SYSTEM
- K111000 — PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
- K111191 — AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
- K111212 — SMR SHOULDER SYSTEM- REVISION STEMS
- K111222 — MRI-Q SYSTEM
- K111393 — SNAP (R) WOUND CARE SYSTEM
- K111400 — OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
- K111804 — INTELLISPACE PACS 4.X
- K111821 — BIOPSY VALVE
- K111892 — VITREAVIEW SOFTWARE 6.1
- K103694 — TISSUE SAMPLING NEEDLE
- K110156 — AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
- K110546 — MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
- K110703 — BD AUTOSHIELD DUO PEN NEEDLE
- K111493 — NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
- K111517 — PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
- K111752 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K111972 — AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
- K101114 — ADVANCIS ACTIVON TUBE
- K110906 — APEX SPINE SYSTEM
- K110942 — PICA WHOLE-BODY MRI SYSTEM
- K111187 — PATCH, PLEDGET AND INTRACARDIAC
- K111209 — INTEGRATED INNOVA - S5I SYSTEM OPTION
- K111388 — DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
- K111582 — LOGIQ S8
- K103285 — DIXTAL DZ-4100 SERIES PULSE OXIMETER
- K110592 — 3.7MM/5.0MM DYNAMIC LOCKING SCREW
- K110990 — GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
- K111213 — VISION ONE LASER SYSTEM
- K111263 — CXI TRIFORCE
- K111555 — CIRCUMAURAL ADHESIVE REPLACEMENT
- K102674 — CUFF SENTRY
- K103414 — VENUS CERVICAL SPINAL FIXATION SYSTEM
- K110271 — MAESTRO WRIST PLATING SYSTEM
- K110529 — ENDOFLIP GASTRIC TUBE
- K110915 — CERVICAL CAGE
- K110943 — LOGIQ E9
- K110984 — SLIM E30 II CO2 LASER
- K110987 — CARDIAC TRIGGER MONITOR
- K111009 — ACRYLIC HERBST APPLIANCE
- K111110 — APNEA GUARD
- K111152 — ROTOGRAPH EVO 3D
- K111302 — MYLABSEVEN, MYLABALPHA
- K111348 — RE / STASIS (TM) GINGIVAL RETRACTION PASTE
- K111524 — MP 719
- K111631 — GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..
- K111866 — NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
- K100305 — ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER
- K101453 — VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
- K101886 — DSC/ALF SPINAL SYSTEM
- K102405 — INFUSION SET FOR POWERPICC SOLO 2 CATHETER
- K103431 — COREN TOTAL HIP SYSTEM
- K103631 — SLEEPMINDER BREATHING FREQUENCY INDICATOR
- K103671 — GENESYS SPINE TILOCK SYSTEM
- K103831 — DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
- K110201 — EXPLOR RADIAL HEAD PLATING SYSTEM
- K110320 — COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
- K110966 — POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED)
- K110970 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
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