FDA 510(k) clearances — page 468
clearances on record, most recent first.
Clearances — page 468
46,701–46,800 of 175,770- K110410 — MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
- K111043 — ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
- K111122 — AESCULAP SIBD XP SPINAL SYSTEM
- K111372 — TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
- K111387 — LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
- K111478 — STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
- K111677 — MICROSCAN(R) MICROSTREP PLUS(R)
- K111911 — CORIN OPTIMOM MODULAR HEAD
- K101934 — DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
- K102760 — ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
- K103796 — TELEMEDCARE HEALTH MONITOR
- K110350 — KNEEHAB XP
- K110707 — CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
- K110735 — TANDA MAX OTC SYSTEM
- K111095 — BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025
- K111195 — VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
- K111376 — CONSTRUX EXTERNAL FIXATION DEVICE
- K111527 — MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
- K111705 — EKOSONIC ENDOVASCULAR SYSTEM
- K112072 — ATRICURE CRYO MODULE SYSTEM
- K102158 — SIGMA STERILIZATION POUCH & ROLL
- K102489 — VANTAGE TITAN 3T
- K103733 — UNITED U2 XPE TOTAL KNEE SYSTEM
- K103802 — TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR
- K110679 — DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
- K110801 — WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
- K110858 — LO-BAK TRAX
- K110991 — MESA SPINAL SYSTEM (KEYSTONE RODS)
- 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
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