FDA 510(k) clearances — page 621
clearances on record, most recent first.
Clearances — page 621
62,001–62,100 of 176,637- K062061 — URASSIST
- K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
- K062337 — MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR
- K062351 — SYNGO DUAL ENERGY
- K062360 — BRANSIST SAFIRE
- K062386 — QANGIO CT
- K062387 — SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
- K062516 — ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
- K062529 — BELMAX CM MODEL X168
- K062556 — ECHELON SHOULDER COIL
- K062680 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML
- K062686 — UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
- K062730 — NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
- K062779 — DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)
- K061005 — ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS
- K061509 — TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
- K061616 — COULTER LH 780 HEMATOLOGY ANALYZER
- K061997 — PREMIER SELF-ETCHING ENAMEL SEALANT
- K061998 — PREMIER SELF-ETCHING BOND ENHANCER
- K062035 — DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL
- K062227 — V.A.C. THERAPY SYSTEM
- K062311 — KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800
- K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
- K062617 — MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
- K062801 — SMARTSUCTION SOLO DEVICE
- K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM
- K061996 — SANDMAN POCKET
- K062040 — SBI TRIHEDRON MTP HEMI GT
- K062113 — SOLAR REUNION FRACTURE STEM
- K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
- K061145 — SPERMSLOW
- K061746 — COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
- K062180 — ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP
- K062244 — OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
- K062320 — SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
- K062344 — GRANDIO SEAL
- K062366 — OPTIME, SINUSORB PGA
- K052544 — PULSE OXIMETER ADAPTER CABLES
- K052870 — INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
- K060012 — CLIRPATH TURBO PERIPHERAL CATHETERS
- K060153 — ACUMED LASER, MODEL 1000
- K061138 — ABX PENTRA 400 : CRP
- K061250 — MULTICATH EXPERT
- K061319 — SPECTRA SYSTEM
- K061568 — CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
- K061850 — MINI-YAG LASER
- K061851 — ZIRKONZAHN ICE
- K061942 — TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237
- K062095 — MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
- K062242 — METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS
- K062304 — DLM112 DAYLINK MONITOR
- K062365 — ARTHREX ASPIRATE KIT
- K062428 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
- K062462 — NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
- K062501 — VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
- K062576 — DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES
- K062586 — XPLORER 1600 PLUS
- K062654 — DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
- K062693 — GLADIATOR BIPOLAR SYSTEM
- K062725 — MAXIFLEX-SEMI FLEX SCOPE
- K062747 — ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
- K060482 — CYTORI CELUTION CELL CONCENTRATION DEVICE
- K061548 — STRYKER URETERAL ILLUMINATION SYSTEM IV
- K061768 — MP-1 MICROPERIMETER
- K061856 — V-2200 INFANT INCUBATOR
- K061906 — CLEARFIL CERAMIC PRIMER
- K062071 — PROMETEY, MODEL G1-03
- K062396 — MODIFICATION TO STOCKERT S5 SYSTEM
- K062401 — MODIFICATION TO LUCAS
- K062451 — NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
- K062514 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K062610 — CARE-E-VAC 3
- K060787 — TATTOOSTAR FAMILY
- K061597 — EPOC BLOOD ANALYSIS SYSTEM
- K061966 — LITETOUCH DENTAL LASER SYSTEM
- K061976 — CKIS-004A INJECTOR SYNCHRONIZATION OPTION
- K062031 — CHASE CARDIAC ANALYSIS SYSTEM
- K062252 — MOLTENO3
- K062356 — KOWA NONMYD ALPHA-D
- K062382 — CLEARFIL DC BOND
- K062385 — BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
- K062429 — MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
- K062599 — MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
- K062679 — ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
- K062758 — OWL URF-3AP
- K060847 — MAGSTIM 200-2
- K061524 — ISS INTEGRATED SPINE SYSTEM
- K062133 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K062410 — CLEARFIL ESTHETIC CEMENT & DC BOND
- K062505 — NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
- K061340 — 23 MM SINGLE-PEG PATELLA COMPONENT
- K061422 — SURGICAL DRAPES
- K061618 — COOLTOUCH, MODEL CTEV
- K061770 — ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
- K061776 — ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
- K061949 — DOUBLEPLAY SUTURE ANCHOR
- K061967 — SCD GARMENT, MODEL VP530
- K062000 — HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH
- K062210 — COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
- K062342 — TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
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