FDA 510(k) clearances — page 489
clearances on record, most recent first.
Clearances — page 489
48,801–48,900 of 176,542- 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
- K110110 — ATRIUM CENTRILFX MESH
- K110176 — AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
- K110287 — PHILIPS ECG LEADWIRE SET
- K100184 — FUSTAR STEERABLE INTRODUCERS
- K102045 — DIMENSION VISA HBA1C, MODEL K3105A
- K103084 — NEODENT GRAFT SCREW
- K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
- K103379 — TELIO CS INLAY & TELIO CS ONLAY
- K103491 — SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
- K093745 — ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
- K093867 — ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
- K100144 — THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
- K101160 — ROCHE ORAL FLUID COCAINE
- K101818 — 4CIS VANE SPINE SYSTEM
- K102321 — DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
- K102449 — BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
- K102471 — AS3700 ANESTHSIA DELIVERY SYSTEM
- K102714 — COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
- K102750 — O2-IN-A-BOX, O2-IN-A-BOX
- K103000 — SMART READ BIOLOGICAL TEST PACK
- K103171 — ELECSYS ANTI-TPO CALSET
- K103238 — 1.5T OPTIMA MR430S
- K103330 — BRIVO MR355, OPTIMA MR360
- K103345 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
- K103346 — DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
- K103352 — VERSAFITCUP CC TRIO
- K103386 — MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
- K103761 — VISUALIZE: VASCULAR
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