FDA 510(k) clearances — page 604
clearances on record, most recent first.
Clearances — page 604
60,301–60,400 of 175,825- K070006 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K060305 — HAIRMAX LASERCOMB
- K062590 — NUVASIVE ACP4 SYSTEM
- K062877 — TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
- K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
- K063417 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K063732 — MICROPLASTY TIBIAL TRAYS
- K060465 — PREMIO
- K062009 — AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
- K062358 — MODIFICATION TO VECTORVISION TRAUMA
- K062363 — BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM
- K062918 — KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
- K063148 — SOCK IT! ORAL PAIN GEL
- K063249 — BEAMAX
- K063396 — VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES
- K063429 — GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
- K063438 — VSPSPN
- K063528 — TROCASYS
- K063539 — NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1
- K063621 — 3 SERIES PHOTOTHERAPY CABINET
- K063653 — MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
- K063736 — FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
- K063739 — SEPRAMESH, MODEL 5959-1214
- K063741 — EXPEDIUM SPINE SYSTEM
- K063744 — COBAS INTEGRA C 111
- K062181 — C-JAWS CERVICAL COMPRESSIVE MINI FRAME
- K062775 — EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
- K062978 — U2 HIP STEM, TI PLASMA SPRAY
- K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
- K060272 — LOCOBASE WOUND AND SKIN EMULSION
- K061430 — SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
- K061431 — EASYGLUCO, MODEL IGM-0002 G2
- K061678 — PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25
- K062670 — VERTIFLEX SPINAL SCREW SYSTEM
- K062759 — PARAMOUNT VBR SYSTEM
- K062800 — CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO
- K062900 — PAJUNKS STIMULONG TSUI-METHOD SET
- K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
- K062996 — DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
- K063052 — LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
- K063170 — TENDER FIBER
- K063217 — VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
- K063278 — PORTLAND COBALT CHROME FEMORAL HEAD
- K063285 — RELIANCE CI PROCESS INDICATOR
- K063309 — TRU-CABLE
- K063345 — SPY IMAGING SYSTEM
- K063370 — CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
- K063409 — LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
- K063462 — NEATSTITCH NEATCLOSE SUTURING DEVICE
- K063554 — MERON PLUS
- K063679 — ACL TOP
- K063721 — NIPRO SAFETOUCH II GAMMA
- K063746 — POWER EXTENDERS MODEL# PEC200, PES200,PES200S
- K063747 — INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A
- K063812 — STRAUMANN PREFGEL
- K063826 — SYNGO MI APPLICATIONS 2007A
- K063121 — PORTABLE X-RAY SYSTEM, MODEL PORT-X II
- K063255 — D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
- K063375 — HEARTSTART MRX, MODELS M3535A OR M3536A
- K063573 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML
- K063610 — DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K063623 — VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
- K063644 — CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
- K061613 — VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
- K062176 — RELIEF ACP ORAL CARE GEL
- K063546 — INSUFLOW DEVICE, MODEL 6198
- K070007 — SPI ELEMENT PLATFORM O 4.0 MM
- K062907 — ALEXIS WOUND RETRACTOR
- K063151 — HUMAPEN LUXURA HD
- K063456 — SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
- K063587 — XODUS MEDICAL ANTI-FOG SOLUTION
- K062439 — POWERTONE, MODEL PT-11
- K062553 — SIMPLEX P BONE CEMENT
- K062937 — TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
- K063103 — AG-EDGE, MODEL 91200
- K063405 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
- K063406 — ENCORE KNEE SYSTEM IFU
- K060415 — MODIFICATION TO: SATELLITE SPINAL SYSTEM
- K062165 — VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
- K062627 — INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
- K062780 — CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
- K063181 — SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- K063470 — AYCAN WORKSTATION OSIRIX
- K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
- K063529 — PENCURE, MODEL VL-7
- K063560 — HILGER DUAL-STIM NERVE STIMULATOR
- K063632 — X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
- K063677 — FUSION QUATTRO EXTRACTION BALLOON XL
- K063718 — SFB AND CFB IMPLANTS - 5.0 PLATFORM
- K063762 — SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
- K063781 — PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
- K063799 — STEAMPLUS STEAM INTEGRATOR
- K063803 — ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
- K061782 — GAMBRO POSICLEAR
- K062675 — GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
- K062755 — IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
- K063338 — HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
- K063509 — DEPUY PEAK FX HIP PLATE
- K063559 — ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
- K063709 — TS-BONE HIP TOOL
Data sourced from openFDA. This site is unofficial and independent of the FDA.