FDA 510(k) clearances — page 607
clearances on record, most recent first.
Clearances — page 607
60,601–60,700 of 176,637- K062433 — DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
- K062521 — OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
- K062976 — MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
- K063316 — FUJINON MODEL EG-530N TRANS NASAL INSERTION
- K063384 — DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
- K063432 — CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
- K070214 — GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
- K070216 — VARI-LASE BRIGHT TIP FIBER
- K070433 — LERADO, POWER WHEELCHAIR, PB
- K070436 — BIOMARC GOLD TISSUE MARKER
- K070440 — BD HYPOINT NEEDLE
- K070442 — POWERLED SURGICAL LIGHT SYSTEM
- K070464 — ONDEMAND3D
- K070487 — SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
- K070563 — VIDAR VISION 2000
- K062222 — UNITIP HIGH RESOLUTION CATHETER
- K062651 — PROCHEM EXT CHEMICAL INTEGRATOR
- K062820 — UNITY ALPHA SYSTEM
- K063210 — ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
- K063490 — SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
- K063581 — SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
- K063645 — FREQUENCER, MODEL 1001
- K063844 — REPROCESSED HEART STABILIZERS AND POSITIONERS
- K063875 — STRYKER FOOT PLATING SYSTEM
- K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
- K070072 — NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES
- K070340 — SECURE ARTERIAL BLOOD SAMPLING SYSTEM
- K070448 — CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
- K070472 — CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230
- K070479 — EXACTECH NOVATION CROWN CUP AND LINERS
- K070496 — ADVACOAT SINUS GEL AND STENT
- K070522 — MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
- K070539 — MORTARA ELI 10 ELECTROCARDIOGRAPH
- K061881 — OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
- K062203 — TINA-QUANT D-DIMER TEST SYSTEM
- K062327 — MODIFICATION TO S4 SPINAL SYSTEM
- K062479 — JOYKEY SURGICAL GOWNS (STERILE)
- K063227 — CONCEIVEX CONCEPTION KIT
- K063353 — CTBOX CERVICAL/LUMBAR TRACTION
- K063364 — ALPHA BIO DENTAL IMPLANT SYSTEM
- K063775 — ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
- K063859 — SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA
- K070096 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
- K070173 — VERTE-STACK SPINAL SYSTEM
- K070262 — ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K070279 — MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
- K070350 — P&F POWER WHEELCHAIR, HC-510
- K070489 — HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT
- K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
- K053342 — GENGIGEL MOUTHRINSE
- K060452 — ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
- K060832 — RETRO-TECH DRESSING
- K062872 — SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
- K063248 — ARCUATE VERTEBRAL AUGMENTATION SYSTEM
- K063352 — ELLEX SLIT LAMP, MODEL 30XL
- K063618 — TENDERFLOW PERIATRIC ARTERIAL CANNULA
- K070223 — AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
- K070285 — LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM
- K070421 — DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
- K060764 — SATURN 3 LASER SYSTEM
- K061122 — NIGHT GUARD
- K063647 — CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
- K063712 — AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
- K070083 — QUANTA LITE H-TTG/DGP SCREEN
- K070190 — GRADIA DIRECT X
- K070308 — FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR
- K061766 — EXPRESSWAY INTERMITTENT CATHETER
- K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
- K062875 — ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
- K062909 — REPEATER PUMP II TUBE SETS
- K062994 — LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
- K063464 — ATLAS SPINE VERTEBRAL BODY REPLACEMENT
- K063504 — ECONOLITH EM1000
- K063830 — REMSTAR AFLEX CPAP SYSTEM
- K070123 — TCA 5R / 5S
- K070226 — CARDIOCT
- K070275 — FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE
- K070369 — REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
- K070370 — 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A
- K070378 — ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
- K070477 — ORISON EMBRACE SYSTEM
- K070508 — BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
- K070528 — PHILIPS ESSENTA DR
- K063149 — ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
- K063445 — PCA CONSTRAINED ACETABULAR LINERS
- K063473 — SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
- K063550 — SYSTEM 12 CONSTRAINED ACETABULAR LINERS
- K063552 — SERIES II CONSTRAINED ACETABULAR LINERS
- K070084 — MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
- K070192 — ATRIUM PROLITE ULTRA S MESH
- K070344 — LIV BREAST SELF EXAMINATION AID
- K062711 — ULTRA LOW PROFILE RONGEUR
- K063001 — SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES
- K063152 — CLAROS DENTAL LASER SYSTEM
- K063486 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY
- K063563 — CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
- K063646 — OPTI
- K063648 — SURGI-WRAP MAST TENDON SHEET
- K063689 — BD DIRECTIGEN EZ FLU A+B TEST
- K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
Data sourced from openFDA. This site is unofficial and independent of the FDA.