FDA 510(k) clearances — page 393
clearances on record, most recent first.
Clearances — page 393
39,201–39,300 of 175,770- K131050 — NXSTAGE 1.6M2 DIALYZER
- K131259 — LASER-STIM
- K131789 — CEREBRALOGIK- AEEG
- K132007 — STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU
- K132481 — EASY-LOAD LENS DELIVERY SYSTEM
- K132674 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
- K133505 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
- K130570 — NEUROVISION MEDICAL MOTION SENSOR
- K132095 — OLEA SPHERE
- K133111 — KINGTECH DIGITAL THERMOMETER
- K133113 — KINGTECH FOREHEAD THERMOMETER
- K133283 — CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
- K133422 — 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
- K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
- K130325 — ARM AUTOMATIC BLOOD PRESSURE MONITOR
- K130519 — PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
- K130572 — INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
- K130975 — SWABCAP AND SWABFLUSH
- K130977 — SIGNIFY BIOACTIVE
- K131164 — ACUSON
- K131169 — MOZEC - RX PTCA BALLOON DILATATION CATHETER
- K131447 — INTUITION - TDA, TVA, PARAMETRIC MAPPING
- K131521 — VELOX ANTERIOR CERVICAL PLATE SYSTEM
- K131724 — PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
- K132511 — FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
- K132601 — COROENT STERILE IMPLANTS SYSTEM
- K132787 — LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
- K133431 — VENUE 50
- K122932 — SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
- K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
- K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
- K131901 — IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
- K132310 — ASCOT
- K132386 — TOTALSHIELD SURGICAL HELMET SYSTEM
- K132500 — CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
- K132854 — EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K133127 — LIPIFLOW THERMAL PULSATION SYSTEM
- K133133 — LAURIMED POLYPVAC MICRODEBRIDER
- K133627 — AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
- K133634 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
- K122162 — AGGREGUIDE
- K123006 — AIR BARRIER SYSTEM (ABS)
- K130052 — TONE-A-MATIC
- K130082 — GENPRIME DRUGS OF ABUSE READER SYSTEM
- K130208 — BERNOULLI ENTERPRISE SOFTWARE
- K130284 — ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
- K130691 — ELECTROTHERAPY DEVICE (COMBO UNIT)
- K131510 — POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
- K131765 — ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
- K131879 — KC 300 SURGICAL MASK
- K131933 — ELECTRONIC PULSE MASSAGER
- K131935 — ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
- K131953 — IMAGE1 SPIES
- K132026 — V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
- K132067 — MULTI ANGLED ABUTMENT SYSTEM
- K132243 — BARLE TISSUE ADHESIVE 2
- K132329 — NIVATOPIC PLUS
- K132342 — XVWEB
- K132428 — IDEAL
- K132530 — GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
- K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
- K132646 — SUNETICS CLINICAL BIO-STIMULATION LASER
- K132652 — VIA MICROCATHETER, VIA PLUS MICROCATHETER
- K132671 — STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
- K132708 — BIOMARC FIDUCIAL MARKER
- K132715 — BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS
- K132776 — SEAL BIOPSY VALVE - REUSABLE
- K132790 — INFIX ANTERIOR LUMBAR SYSTEM
- K132887 — AIRFIT N10
- K132917 — OCULAR FORCE GAUGE
- K132998 — WANDY SELF-ADHESIVE ELECTRODES
- K133052 — AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
- K133078 — K-ETCHANT SYRINGE; NEEDLE TIP (E)
- K133169 — MESO TENDON MATRIX
- K133281 — NEOTRACT UROLIFT SYSTEM
- K133338 — LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX)
- K133367 — ORTHOVIS PREOPERATIVE PLAN
- K133423 — REST ASSURED EXTRA COMFORT NITE PROTECTOR
- K133503 — AMPLIVUE GBS ASSAY
- K133513 — MULTI-STAGE SNARE
- K133563 — PATHASSIST LIGHT SEEKER
- K133566 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
- K133569 — TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
- K133587 — PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300
- K133605 — BD MAX MRSA XT, BD MAX INSTRUMENT
- K133626 — AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
- K133630 — GMK SHORT STEM
- K133641 — CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
- K133650 — CAPSTONE SPINAL SYSTEM
- K123030 — COMPRESSOR NEBULIZER MODEL MCN-S600XX
- K123209 — SOFTVUE
- K124064 — YOUNG AGAIN
- K130579 — PHYSOFT AMS
- K130611 — ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
- K131381 — ELISIO-H HEMODIALYZER
- K132086 — ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
- K132368 — VAPOR CERAMIC BRACKET
- K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS
- K132623 — MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
- K132794 — SMARTVEST AIRWAY CLEARANCE SYSTEM
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