FDA 510(k) clearances — page 481
clearances on record, most recent first.
Clearances — page 481
48,001–48,100 of 175,770- K103222 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K103337 — MULTIPLE NAME
- K103397 — ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
- K103449 — BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
- K103528 — IPS EMPRESS DIRECT FLOW
- K103772 — VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
- K110120 — ECHELON RAPID CARDIAC COIL
- K110163 — APPROACH PRO ST WIRE GUIDE
- K110241 — ENDOLOGIX GUIDEWIRE
- K110428 — ESCOM 100
- K090414 — SPECTRASHIELD 9500 SURGICAL MASK
- K101708 — PATIENT SAFE LUER CAP
- K101797 — SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T
- K102539 — ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
- K102597 — PICCOLO COMPOSITE PLATE SYSTEM
- K103059 — TROPHON
- K103119 — BILLY BOY MALE LATEX CONDOM
- K103253 — SILS PORT
- K103280 — BHDENTAL IMPLANT SYSTEM
- K103478 — SINGLE USE BILIARY DRAINAGE STENT V
- K103535 — VACPLUS SUCTION UNIT
- K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- K110080 — RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
- K110193 — FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F
- DEN110001 — RIDASCREEN NOROVIRUS 3RD GENERATION EIA
- K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
- K101732 — ASTRA TECH IMPLANT SYSTEM
- K102125 — PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
- K102192 — INDISCAL DIGITAL MANOMETER
- K102769 — NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
- K102939 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
- K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
- K103076 — DYNAFLEX
- K103128 — CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
- K103264 — ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
- K103354 — EBONY PTA .035 PERIPHERAL DILATATION CATHETER
- K103634 — ASCOM CLINICALCONNEX CARDIOMAX
- K103825 — V-GO INSULIN DELIVERY SYSTEM
- K110228 — NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
- K101793 — MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
- K102270 — ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
- K103445 — ALACER SURGICAL SCAFFOLD
- K103708 — ML24000 UVA-1 PHOTOTHERAPY UNIT
- K101233 — SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
- K101388 — FASTPACK TESTO IMMUNOASSAY
- K101838 — VTS1000
- K102076 — LIQUIBAND DUAL, MODEL LBD 001
- K102206 — ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
- K102259 — DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K102295 — X2ABS DUAL CHANNEL FITNESS BELT
- K102560 — REPROCESSED PULSE OXIMETER SENSORS
- K102776 — EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
- K102840 — PATIENT EXAMINATION GLOES
- K102961 — HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM
- K102968 — INFINITY CNAP SMARTPOD
- K103226 — STERILIZATION MATS
- K103255 — VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
- K103260 — VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
- K103302 — STEMPRO MSC SFM
- K103558 — SYNTHES SCOUT VESSEL GUARD
- K103576 — MIM 5.2 (BRACHY)
- K103701 — ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
- K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
- K110330 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K093610 — MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
- K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS
- K101510 — FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
- K101893 — NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS
- K102803 — CLARITY ADVANCED CERAMIC BRACKETS
- K103001 — ROCKWOOD CLAVICLE PINS
- K103175 — FILMARRAY RESPIRATORY PANEL (RP)
- K103383 — SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
- K103391 — IVOBASE HYBRID, IVOBASE HIGH IMPACT
- K103490 — EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
- K110008 — GOLIFE NASAL MASK
- K110118 — STIMTRODE SINGLE USE NERVE STIMULATOR
- K110154 — ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
- K110160 — BEL-CYPHER N
- K110168 — ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
- K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
- K110238 — G-SCAN
- K102637 — DYNAREX ULTRASOUND GEL
- K103321 — DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
- K103355 — GDC 360 DETEACHABLE COIL
- K103494 — ZENOSTAR MAGIC GLAZE
- K103665 — CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O
- K103678 — CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
- K103836 — ENZYME II CALIBRATOR
- K110183 — ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
- K091207 — SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
- K102109 — ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
- K102366 — FINESS ENDOSCOPE
- K102762 — ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
- K102763 — SYSTEMS INTEGRATION
- K103517 — TRABECULAR METAL FEMORAL CONE AUGMENTS
- K103693 — VANTAGE ABI
- K103753 — SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
- K103819 — PSL ANTERIOR CERVICAL PLATE SYSTEM
- K103838 — FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
- K110056 — AFINION ANALYZER
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