FDA 510(k) clearances — page 774
clearances on record, most recent first.
Clearances — page 774
77,301–77,400 of 176,637- K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
- K014260 — TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE
- K014268 — NORAPAD PLAIN; NORAPAD TA
- K014272 — PERIOLASE ND:YAG DENTAL LASER SYSTEM
- K014304 — BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
- K020031 — EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
- K020269 — PROCERA ALLCERAM BRIDGE MATERIAL
- K020322 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K020611 — UNIVERSAL BONE PLATE III SYSTEM (UBP III)
- K020680 — PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
- K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
- K020881 — MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
- K004022 — M3 (MIRCO-MULTILEAF COLLIMATOR
- K010131 — PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
- K010744 — FLOWTRON UNIVERSAL, MODEL AC600
- K012406 — ACCESS SEQUESTRATION SYSTEM
- K012852 — EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
- K013426 — MOONRAY MOBILE C-ARM
- K014030 — 1,25-DIHYDROXYVITAMIN D125I RIA
- K014236 — CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES
- K014243 — BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050
- K014251 — NTERO HOTROD SYSTEM
- K014253 — DERMACHILLER 4
- K014259 — SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K014262 — COSMED QUARK C12/QUARK T12
- K014303 — JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
- K020159 — SMITH & NEPHEW TWINFIX TI QUICK T
- K020479 — DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
- K020796 — CARD IQ ANALYSIS II
- K020862 — I-FLOW ELASTOMERIC PUMP
- K004009 — 3M ATTEST 290 AUTO-READER
- K011363 — JOE LUBE CONDOM
- K011378 — JOE LUB HELMET CONDOM
- K011388 — ZOLL PAD
- K020256 — UNICEM
- K020870 — VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
- K020596 — CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
- K014240 — PRONTO
- K020037 — DRIED GRAM NEGATIVE MIC/COMBO PANELS
- K020580 — X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
- K012915 — DINAMAP PRO 1000 MONITOR, MODEL 1000
- K014139 — DIABETES ASSISTANT SOFTWARE
- K014189 — ODI TALON INTRAMEDULLARY HIP NAIL
- K014197 — SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
- K014207 — REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
- K014216 — SECCA SYSTEM
- K014248 — DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
- K020001 — PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
- K020002 — MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
- K020007 — SAFYRE SLING SYSTEM
- K020091 — OPTILUX 501
- K020175 — URS-IG (GLUCOSE TEST)
- K020180 — RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
- K020450 — VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108
- K020522 — MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
- K020557 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
- K020558 — LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
- K020635 — KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976
- K020733 — PVS 1500 SDS
- K020737 — CAT ACTIVE WHEELCHAIR
- K011590 — RESORB-X RESORBABLE PLATING SYSTEM
- K011688 — PELVICFLEXER EXERCISE DEVICE
- K012989 — DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
- K012996 — BARBITURATES
- K013001 — METHADONE
- K013100 — PROPOXYPHENE
- K014101 — RAPIDONE-OXY TEST
- K014175 — SULZER DENTAL CERAMIC SYSTEM-HEXLOCK
- K014279 — LATEX EXAMINATION GLOVES (POWDER FREE)
- K014280 — LATEX EXAMINATION GLOVE (POWDERED)
- K020136 — VISUALINE BARBITURATES DIPSTRIP TEST
- K020239 — TOUCH&BOND-PLUS
- K020310 — DAVLITE MICROENDOSCOPE & ACCESSORIES
- K020316 — CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU
- K020331 — PASCO MIC AND MIC/ID PANELS
- K020523 — BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
- K020524 — PATIENTNET MONITORING SYSTEM
- K020531 — PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B
- K020590 — MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
- K020660 — HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
- K020777 — BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
- K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
- K012825 — HEARTTRENDS
- K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM
- K014172 — NELSON ELECTROSURGICAL UNIT, MODEL GN640
- K014195 — KAYAK HYDROPHILIC GUIDE WIRES
- K014214 — SULZER DENTAL CERAMIC SYSTEM-SPLINE
- K020237 — IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
- K020500 — UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
- K020526 — MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
- K013201 — CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
- K014149 — PAEDISCOPE, MODEL # P010A AND PF011A
- K014154 — VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00
- K014155 — OPENING/CLOSING WEDGE OSTETOMY PLATES
- K014156 — CERASORB ORTHO
- K020049 — FORTAFLEX SURGICAL MESH
- K020069 — MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
- K020593 — CONVERTORS SMS POLYOLEFIN GOWN
- K012755 — AUTODIMER ASSAY MODEL # 1431
- K012778 — VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS
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