FDA 510(k) clearances — page 792
clearances on record, most recent first.
Clearances — page 792
79,101–79,200 of 175,825- K011441 — JAS CALCIUM (ARSENAZO) REAGENT
- K011482 — DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K011498 — EASY CONTROL MICRO INSERTER, MODEL ON385
- K011512 — MMODIFICATION TO LAMINARIA
- K011566 — QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
- K011570 — QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
- K011668 — VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
- K011669 — BW ACUPUNCTURE NEEDLES
- K011728 — BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (
- K011804 — CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
- K011864 — TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
- K011895 — POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
- K010503 — AMIGO WHEELCHAIR
- K011099 — GLOBAL FX POROUS-COATED HUMERAL STEM
- K011243 — CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
- K011787 — PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
- K003818 — TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
- K010668 — BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
- K010964 — AUTO-DRIVE LAG SCREW SYSTEM
- K011130 — PREMIUM
- K011170 — SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
- K011436 — MOBILE-PATIENT VIEWER
- K011492 — IN TEN-S
- K011713 — SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
- K011731 — TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
- K011922 — POWDERED LATEX EXAMINATION GLOVES
- K002580 — PRAIRIE CRUISER
- K002835 — BODYSTAT
- K003438 — SMART RAD
- K003855 — HYALOMATRIX CO
- K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
- K011041 — WATERLASE, MILLENNIUM
- K011114 — ETYMOTIC RESEARCH ER-10D OAE PROBE
- K011141 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
- K011350 — STARBAND CRANIAL ORTHOSIS
- K011734 — 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
- K011766 — 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027
- K011797 — BIOZTECT SENSOR AND BIOZTECT CABLE
- K010599 — PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
- K011110 — M2A ACETABULAR SYSTEM
- K011171 — TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
- K011199 — PROVIEW EYE PRESSURE MONITOR
- K011302 — RANDOX DIGOXIN
- K011303 — RANDOX PHENOBARBITAL
- K011478 — I-STAT SYSTEM
- K011481 — 10% PVP; 10% PVP IN EBSS SOLUTION
- K011505 — IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
- K011573 — HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
- K011719 — PLUS CANCELLOUS BONE SCREWS
- K011740 — CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
- K011824 — AGILENT M2636B TELEMON B MONITOR (TELEMON B)
- K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
- K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
- K010029 — HOME HEALTH MONITORING SYSTEM
- K010139 — ZURICH DISTRACTION SYSTEM
- K010311 — LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
- K010692 — THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
- K011000 — TRAM 2001 MODULE
- K011375 — AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K011394 — LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
- K011619 — PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
- K011711 — MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
- K002409 — MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
- K003180 — HOMMED OBSERVER, MODEL I
- K003663 — SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
- K003759 — AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
- K003999 — AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
- K010422 — ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
- K010590 — NEUROPACK MICRO, MODEL MED-9100A SERIES
- K011047 — GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
- K011061 — SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
- K011083 — ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
- K011317 — MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM
- K011346 — READYSWIM
- K011359 — MODIFICATION TO KSEA ENDOTIP SYSTEM
- K011643 — SCORPIO CR SUPERFLEX TIBIAL INSERT
- K011699 — VACUETTE EVACUATED BLOOD COLLECTION TUBES
- K011714 — BIPAP PRO BI-LEVEL SYSTEM
- K011752 — GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY
- K011831 — MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
- K003182 — ORTHOGENESIS LPS SYSTEM
- K010745 — EMS 3000
- K010888 — SIDEPORT PINCH CLAMP DEVICE
- K010943 — SYNTHES STERNAL FIXATION SYSTEM
- K010950 — CYPRESS SYSTEM
- K010965 — A-LINE AEP MONITOR
- K010998 — LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
- K011034 — SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
- K011075 — EASYBELL
- K011180 — CT/MASTER, VERSION 1.0
- K011295 — RESTORE-PF VIC; RESTORE-PF VLC CAPSULE
- K011299 — SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
- K011490 — MODIFICATION TO EXCITE
- K011697 — EBI XFIX ACCESS PELVIC FIXATOR
- K011704 — NPAC EAR THERMOMETER MODEL TD 402
- K011860 — KEYST0NE MEDICAL PICC CATHETER
- K003927 — Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
- K010938 — SYNGO MULTIMODALITY WORKSTATION
- K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
- K011209 — MANAN SPRITACRE SPINAL NEEDLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.