FDA 510(k) clearances — page 760
clearances on record, most recent first.
Clearances — page 760
75,901–76,000 of 175,825- K014193 — LIFESIGN DOA 4 (THC/OPI/COC/MET)
- K020321 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K020439 — STATUS HCG SERUM/URINE
- K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
- K020620 — BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
- K020684 — FINESUN EMS STIMULATOR
- K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
- K021286 — MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
- K021312 — EBI DFS OPTIROM ELBOW FIXATOR
- K021324 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
- K013642 — AVEA
- K013846 — ULTRAGARD IMPERVIOUS REINFORCED GOWN
- K014283 — LATEX SURGEONS GLOVE (POWDER FREE)
- K020465 — MEDCOMP ASH SPLIT-CATH II
- K020577 — APPLIED URETERAL CATHETER
- K020584 — N2000 BASE STATION; N2001 NURSE STATION
- K020600 — BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
- K020730 — ORION NASAL CPAP SYSTEM
- K020774 — IMAGINE H.E. PRESS DESIGN-CERAMIC
- K020908 — HDM97
- K020909 — HDM99
- K021013 — SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
- K021082 — ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
- K021225 — ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
- K021268 — ECLIPSE, HELIOS OPTION
- K021323 — MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
- K021435 — DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
- K021447 — TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
- K021460 — OCO DENTAL IMPLANT
- K021465 — MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
- K021491 — HISPEED DUAL
- K021591 — PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
- K013827 — TST - SUPPRESSOR MODEL #1000
- K013897 — SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
- K013982 — KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
- K020563 — MEDAMICUS AXIA RSN
- K020790 — INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
- K020846 — ULTIMA TENS XL-A1
- K020993 — ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
- K021262 — MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
- K021272 — SIB CATHETER, MODEL 61-7005
- K021310 — 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
- K021331 — DEXACARE G4
- K021479 — CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
- K021522 — LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
- K021530 — SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
- K020298 — GALILEO CAS/NAV TKR SYSTEM
- K020541 — AGILITY ANKLE REVISION PROSTHESIS
- K020574 — TISSUELINK BIPOLAR FLOATING BALL DEVICE
- K020602 — SYNTHES PILON PLATE
- K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
- K020849 — APEX 800 LASER SYSTEM, MODEL APEX 800
- K020867 — BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
- K020902 — SERRALESTER
- K021025 — MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
- K021343 — ISOSEEDS I-125
- K011344 — INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
- K012496 — CARBON POST
- K020113 — VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
- K020747 — AMSCO CENTURY MEDIUM STERILIZER 26 X 26
- K020799 — QUICKVUE ONE-STEP HCG-URINE
- K020801 — QUICKVUE ONE-STEP HCG-COMBO
- K020939 — MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
- K021095 — HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
- K021212 — 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
- K021219 — SMARTWIRE/SMARTMAP PRESSURE SYSTEM
- K021256 — Z3 GUIDE CATHETER
- K021274 — PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
- K021487 — SIMPLICITY EASY ACCESS P INFUSION SET
- K011726 — MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
- K013596 — MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
- K013764 — IMMIX BONE GRAFT EXTENDER
- K013966 — APATIGHT-TCP BONE GRAFT SUBSTITUTE
- K014235 — OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
- K020398 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
- K020512 — MTI ST#1 SILICONE PESSARY
- K020513 — EPY-50
- K020514 — PULPDENT GLAZE II
- K020516 — CARE IFC PLUS
- K020562 — APEX INTRAMEDULLARY NAIL SYSTEM
- K020591 — BCLEAR
- K020608 — HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
- K020734 — SURGE-FREE ASPIRATION ADAPTER
- K020847 — XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
- K020887 — EBI AIS SPINE SYSTEM
- K020927 — BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
- K020956 — VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
- K021001 — SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES
- K021024 — HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- K021031 — EBI XFIX RAIL SYSTEM
- K021092 — PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
- K021145 — ACCOMMODATOR WHEELCHAIR, MODEL #2000X
- K021192 — QACA IGG/IGM ELISA KIT HRP
- K021232 — CONSTELLATION CATHETERS, MODEL 8031M
- K021242 — PORTALLOY 54
- K021367 — STERNGOLD 66, MODEL #1180230
- K021371 — SUNSPEX TECHNOLOGIES MODEL SE 02
- K021382 — SYNTHES (USA) AUTOMATED TACK DRIVER
- K021396 — DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
- K021514 — PHILIPS PLS9W/12/2P UVB
Data sourced from openFDA. This site is unofficial and independent of the FDA.