FDA 510(k) clearances — page 532
clearances on record, most recent first.
Clearances — page 532
53,101–53,200 of 176,542- K091338 — COLLASORB COLLAGEN WOUND DRESSING
- K091398 — ARTHROSCOPE
- K091820 — CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
- K092423 — XPECT FLU A & B
- K092572 — CORE*IT DUAL
- K083208 — SATURN ACTIVE LASER SYSTEM
- K090258 — VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
- K090936 — SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
- K091144 — SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
- K091251 — CERNER FETALINK (VERSION 1.0)
- K091292 — BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
- K091423 — PROFEMUR HIP SYSTEM MODULAR NECKS
- K091439 — HEAD FIXATION ARC AND TABLE BASE
- K091600 — DIRECTVISION GUIDE SYSTEM
- K091821 — COMMANDER 111, MODEL CD300-CD399
- K091897 — BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
- K092004 — GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
- K092102 — NORDICBRAINEX SOFTWARE, VERSION 1.0
- K092307 — IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR
- K092357 — CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
- K090581 — TANTALUM BEAD SET, MODEL P003175
- K091200 — XTRACT SYRINGE KEYS
- K091306 — AMSURE PVC INTERMITTENT CATHETER
- K091412 — CLEAN PEAK FLOW METER
- K091430 — CARE PAL, MODEL CPW-10X
- K091452 — FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
- K091465 — MYOSURE ROD LENS HYSTEROSCOPE
- K091628 — OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
- K091902 — 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
- K092140 — GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
- K092217 — MERCURY VCO2
- K092291 — SKINTACT AND VARIOUS OTHER TRADENAMES
- K082977 — BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
- K083448 — CABLE, TRANSDUCER, MODEL 2400GN
- K083747 — TERUMO PALL AL3X ARTERIAL FILTER
- K090710 — MERCURY CPAP
- K090783 — TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE
- K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
- K091682 — LSVT C OR LSVT COMPANION, MODEL V.1
- K092053 — MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH
- K092201 — ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE
- K092222 — THERMAPULSE
- K092500 — MODIFICATION TO PROFLU+ ASSAY
- K082699 — ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
- K091320 — SPECTRA SP II, SPECTRA DENTA II
- K091497 — K-LASER K-1200, MODEL 12 W
- K092232 — MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
- K092323 — CONTURA CAVITY MAINTENANCE CATHETER
- K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
- K083250 — NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
- K090169 — SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
- K090818 — KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
- K091186 — KODAK 1500 INTRAORAL CAMERA
- K091408 — DISPOSABLE PRESSURE TRANSDUCER
- K091481 — EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
- K091737 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
- K091738 — SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
- K091739 — SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
- K091827 — S. AUREUS PNA FISH
- K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II
- K091074 — AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
- K091134 — CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
- K091533 — SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
- K091976 — BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
- K092022 — TISSU TRANS HARVEST TUBING
- K080564 — SCANSCOPE XT SYSTEM
- K082947 — LENSX 550 LASER SYSTEM
- K083758 — SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
- K090048 — ASFORA BULLET CAGE SYSTEM
- K090332 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
- K090740 — MODIFICATION TO: TSRH SPINAL SYSTEM
- K090995 — B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
- K091123 — ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
- K091288 — MEDI-6000 MEDICAL IMAGE DIGITIZER
- K091455 — DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
- K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
- K091742 — SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
- K091763 — MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
- K091899 — VITEK 2 GRAM NEGATIVE MEROPENEM
- K063461 — ANOVA CONTAINMENT DEVICE
- K080844 — G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
- K081246 — TT-102
- K083382 — CHROMA, MODEL: RZ153C
- K083571 — ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
- K090337 — TROPAZONE LOTION
- K090571 — ALMA LASERS ALEX755 MODULE
- K090727 — IMM DENTAL IRRIGATION TUBING SET
- K090774 — LIGHTLAS SELECTOR
- K090781 — HELIO2 BLENDER
- K091059 — FOXQ 980 LASER
- K091238 — UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
- K091782 — REVERE 6.35 STABILIZATION SYSTEM
- K092108 — TRUSS THORACOLUMBAR PLATE SYSTEM
- K083728 — INVISION SYSTEM
- K090551 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K090576 — FOOTPRINT URINARY DRAINAGE CATHETER
- K090681 — TANSCU O2
- K091230 — HDR PROSTATE TEMPLATE AND ACCESSORIES
- K091279 — NIPRO DISPOSABLE SYRINGE
- K091453 — LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
Data sourced from openFDA. This site is unofficial and independent of the FDA.