FDA 510(k) clearances — page 602
clearances on record, most recent first.
Clearances — page 602
60,101–60,200 of 175,825- K063700 — SPYGLASS IRRIGATION SYSTEM
- K063725 — MP5 INTELLIVUE PATIENT MONITOR
- K063820 — LISFRANC PLATE
- K063839 — POSITIONER
- K070008 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K070028 — CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
- K070043 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE
- K070122 — MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320
- K070160 — MODIFICATION TO TTC PLATES
- K070241 — MODIFICATION TO LAPIDUS PLATE
- K060564 — INFINITI SYSTEM
- K061982 — PLEXUR P
- K062793 — SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
- K063603 — SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
- K063660 — OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
- K063831 — BASAL DORSAL PLATES
- K070046 — POWDERED VINYL PATIENT GLOVE
- K070219 — SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM
- DEN070009 — MAMMAPRINT
- K061516 — STAODYN MAX PRESET, MODEL 4470
- K062554 — STARCLOSE HEX-HUB DILATOR
- K062799 — GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
- K063167 — EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)
- K063840 — XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION
- K063856 — EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
- K061919 — VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
- K062098 — SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
- K062205 — DBX STRIP
- K062339 — DERMOTHERAP GUN
- K062646 — RUIKE, MODEL 3411
- K062893 — KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
- K062912 — SCIENT'X SPINAL SYSTEM
- K063135 — SONIC-STIM
- K063368 — NIPRO BIOHOLE NEEDLE
- K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR
- K063715 — JUNIPER COOLING DEVICE XTRA
- K063800 — CANDELA FLUORESCENT PULSED LIGHT SYSTEM
- K070069 — ZIPPREP ELECTRODE
- K070297 — CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT
- K061108 — STRYKER AUTO IRRIGATION SYSTEM
- K062250 — DELTA XTEND REVERSE SHOULDER SYSTEM
- K063011 — MIRAGE LIBERTY FULL FACE MASK
- K063122 — MIRAGE QUATTRO FULL FACE MASK
- K063126 — DANA DIABECARE IIS
- K063418 — ACON DIGITAL THERMOMETER PROBE COVERS
- K063511 — CERAMILL ZI
- K063515 — TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
- K063593 — CLEARFIL MAJESTY FLOW
- K063672 — FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
- K063711 — TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
- K063816 — PCA ALUMINA FEMORAL HEADS
- K070001 — MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
- K070078 — STRYKER T4 HYTREL TOGA
- K061445 — SURGIMESH WN
- K062414 — VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
- K062543 — HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
- K063111 — FINOMETER MODEL-2 WITH ACCESSORIES
- K063652 — GLOBAL AP POROUS COATED HUMERAL STEM
- K063748 — THERMOMED 1.8
- K063855 — LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047
- K070025 — C.T.M. MOBILITY SCOOTER, MODEL HS-310
- K070144 — INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K070157 — OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
- K061571 — ASTRA 300
- K061720 — COSMELIGHT
- K061931 — SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101
- K062114 — CERULOPLASMIN, MODEL 2055953
- K062303 — FRAXEL II SR LASER SYSTEM
- K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
- K062379 — COBAS INTEGRA CERULOPLASMIN
- K062497 — REPROCESSED TROCARS
- K062511 — AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
- K062604 — RAPIDTEG TEG-ACT TEST
- K062933 — SYNTHES ORACLE SPACER
- K063326 — CONMED LINVATEC 24K IRRIGATION SYSTEM
- K063472 — ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200
- K063585 — KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
- K063589 — GSO BONE FIXATION FASTENERS
- K063654 — ENDOGUIDE
- K063691 — NEUTRON THERAPY SYSTEM
- K063714 — AXCEL FLOW
- K063730 — DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
- K063773 — VOLUMETRIC TOMOGRAPHY
- K070017 — PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
- K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
- K070079 — X3C DIGITAL RADIOGRAPHIC DETECTOR
- K070129 — SONOTIP II ULTRASOUND NEEDLE SYSTEM
- DEN060006 — COMPUTERIZED LABOR MONITORING SYSTEM
- K063192 — HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP
- K063238 — ULTRACLIP II WING AND ULTRACLIP II COIL
- K063290 — GAMBRO QUICKSET BLOODLINES
- K070063 — YAG MIR II LASER
- K062530 — TRIAGE PROTEIN C TEST
- K062559 — URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
- K062615 — VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
- K062925 — COAGUCHEK XS SYSTEM
- K063300 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML
- K063431 — 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
- K063433 — ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200
- K063536 — POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
Data sourced from openFDA. This site is unofficial and independent of the FDA.