FDA 510(k) clearances — page 692
clearances on record, most recent first.
Clearances — page 692
69,101–69,200 of 175,825- K040925 — NORMAL AND HYPERGAMMA CONTROL SERUM
- K040989 — RITA SYSTEMS
- K033085 — PORTACLAMP
- K033098 — OSTEOGEN SBRG
- K033163 — CAUTION CONDOMS
- K033171 — NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
- K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM
- K033611 — CALCIGEN -NAP BONE VOID FILLER
- K033905 — PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING
- K040054 — BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
- K040067 — CLIRPATH EXCIMER LASER CATHETER
- K040185 — DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
- K040193 — MODEL GST-1
- K040440 — HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)
- K040489 — AQUADEX SYSTEM 100, MODEL A1100
- K040546 — IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
- K040632 — SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
- K040702 — SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
- K040764 — STRYKER T4 HYTREL ZIPPER TOGA
- K040984 — VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
- K020700 — PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
- K022256 — SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
- K030071 — SERVO GUARD, MODEL 64 81 290 EH88E
- K033114 — KETOCHECKS
- K033498 — NARKOMED 6400, MODEL NM6400
- K034063 — MULTIBLAST MEDIUM
- K040287 — VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
- K040605 — DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
- K040846 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
- K031661 — 5M MEDICAL FLAT PANEL DISPLAY, ME511L
- K033153 — DICOM THEATER
- K033860 — AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
- K040194 — COMPUMEDICS SUMMIT IP
- K040468 — CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO
- K040727 — CRYO 5
- K040771 — MODIFICATION TO OUTBACK CATHETER
- K040775 — LIFEPAK 12
- K040821 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES
- K040852 — PREVIEW TREATMENT PLANNING SOFTWARE
- K040884 — LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
- K040937 — TEM 3000 HEAD COIL
- K030747 — PRODOSE AAD SYSTEM
- K032981 — SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
- K033534 — VITALSENSE
- K033699 — LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
- K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
- K033914 — OXYGEN DIVERTER VALVE
- K040148 — RESOLUTION HEMOSTASIS CLIPPING DEVICE
- K040259 — MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
- K040396 — ULTRASONIC SCALER ELEGANCE MS-10 (25K)
- K040495 — NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
- K040537 — AMS APOGEE VAULT SUSPENSION SYSTEM
- K040545 — OTTER SAFETY SYRINGE
- K040567 — GC INITIAL MC, AL AND LF
- K040584 — NMX-1000
- K040607 — MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
- K040743 — MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
- K040770 — VANGUARD PATELLA COMPONENTS
- K040796 — ACCU-CHEK GO SYSTEM
- K033092 — THE GNATHOMETER
- K033630 — MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
- K034056 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K040117 — UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
- K040902 — HITACHI PRESTO
- K040910 — INFANT INCUBATOR, MODEL CHS-I1000
- K033006 — MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
- K033123 — STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
- K033485 — ENDOSCOUT
- K040085 — PERSONAL WARMING LUBRICANT
- K040116 — HAWK INTRAORAL CAMERA AND ACCESSORIES
- K040131 — COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
- K040235 — LICOX PMO BRAIN MONITORING SYSTEM
- K040236 — PULPDENT VLC RESIN CEMENT
- K040909 — SONO TT ULTRASONIC FLOWCOMPUTER
- K030366 — BICARD MIXING SYSTEM
- K033005 — MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY
- K033104 — MGD 2621P MEDICAL GREYSCALE DISPLAY
- K040125 — SENOGRAPHIC STEREO
- K040126 — VIATRONIX V3D COLON, REVISION 1.3
- K040327 — ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
- K040402 — ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
- K040509 — ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
- K040786 — VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
- K040828 — DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
- K040876 — ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE
- K040940 — BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
- K032447 — CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED
- K032806 — KATALYST RADIAL HEAD IMPLANT
- K032976 — BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
- K033004 — MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY
- K033103 — MGD 2621L MEDICAL GREYSCALE DISPLAY
- K033871 — IM TOTAL FEMUR
- K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K040163 — MICROVASCULAR ANASTOMOTIC DEVICE
- K040261 — REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
- K040482 — EBI ESL SPINE SPACER SYSTEM
- K040622 — FREEDOM HP
- K040707 — PACKAGING TRAY AND COMPONENTS
- K040855 — INSTRUMED LAPAROSCOPE AND ACCESSORIES
- K023916 — BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
Data sourced from openFDA. This site is unofficial and independent of the FDA.