FDA 510(k) clearances — page 669
clearances on record, most recent first.
Clearances — page 669
66,801–66,900 of 176,637- K050755 — MODIFICATION TO BVBLUE
- K042470 — DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
- K042505 — OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
- K042506 — OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
- K043503 — VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
- K043527 — RELIEVA SINUS BALLOON DILATION CATHETER
- K050131 — INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
- K050134 — ICC INSULIN SAFEPRO SAFETY SYRINGE
- K050169 — HL 200 ELECTRONIC STETHOSCOPE
- K050505 — DEPOTONE
- K050515 — BONE BLOCK FIXATION SET
- K050567 — HEALTH BUDDY APPLIANCE
- K050587 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM
- K050614 — MUSE CARDIOLOGY INFORMATION SYSTEM
- K050648 — SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
- K050742 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
- K032959 — CIDEX OPA CONCENTRATE
- K041614 — MICROLUX DL
- K043324 — AIDA WITH DICOM AND HL7 INTERFACE
- K050450 — SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
- K043533 — SURGICAL DESIGN CIRCUMCISION CLAMP
- K050115 — BLOOD HAND PUMP ADMINISTRATION SET
- K050419 — QMS VANCOMYCIN
- K050488 — TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
- K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
- K050513 — MDA B.30
- K050548 — CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
- K050645 — CORDIS AMIIA .014 PTA BALLOON CATHETER
- K050671 — ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
- K050701 — THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
- K043352 — GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR
- K043363 — FRESENIUS LIBERTY CYCLER
- K043418 — COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
- K043467 — FLEXIBLE SPINAL NEEDLE
- K043515 — GRAFTSAVER
- K043594 — VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
- K050047 — CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
- K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
- K050294 — COOK IRELAND SONNET POLYPECTOMY SNARE
- K050319 — MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
- K050491 — H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF
- K050639 — LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
- K050679 — CUTERA SOLERA OPUS AESTHETIC PRODUCT
- K050730 — MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
- K050737 — NEOTHERMIA EN-BLOC BIOPSY SYSTEM
- K040335 — MOONCUP, STYLE A & B
- K043204 — SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
- K050040 — MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR
- K050106 — NOVOFINE AUTOCOVER 30G X 8MM
- K050217 — FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
- K050221 — HEMOSIL SILICA CLOTTING TIME
- K050249 — HL168JP
- K050467 — POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
- K050577 — ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
- K050670 — SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS
- K050698 — MODIFICATION TO:ZILVER 518 BILIARY STENT
- K050710 — MINIMASTER ULTRASONIC SCALER
- K042384 — NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
- K043600 — MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
- K050043 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
- K050328 — PREGNANCY-SKREEN
- K050341 — IMPLANT LOCATION SOFTWARE, MODEL 0.1.0
- K050345 — CIE FOLDAWAY WHEELCHAIR
- K050416 — OSSAPLAST ORTHO
- K050455 — SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
- K050539 — SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
- K050563 — EKOS PERIPHERAL INFUSION SYSTEM
- K050667 — R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE
- K042626 — NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
- K043556 — SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
- K050213 — FRESHLOOK ONE-DAY COLOR CONTACT LENS
- K050552 — PACHPEN PACHYMETER, MODEL 24-5100
- K050623 — VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
- K040419 — DYNAGRAFT II
- K041881 — ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
- K042091 — BIOLOX DELTA CERAMIC HEADS
- K043183 — EPI-K
- K043392 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS
- K043590 — SE INFUSION SYSTEM WITH MMS
- K050028 — MAESTRO CARPAL HEMIARTHROPLASTY
- K050039 — MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR
- K050070 — K-LASER, MODELS 3,4,4D,6D
- K050190 — APOLLO
- K050295 — PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
- K050309 — PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
- K050372 — VISITRAK, VERSION 1, RELEASE 1
- K050476 — CORDLESS COIL
- K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
- K050504 — VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
- K050509 — LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
- K050514 — MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
- K050597 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K050626 — GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
- K050697 — MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
- K041066 — ENCORE REVERSE SHOULDER PROSTHESIS
- K041715 — INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
- K043063 — OXYBAND WOUND DRESSING
- K043454 — CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
- K043521 — BIOSYAG 50 MED
- K043580 — ALLIGATOR RETRIEVAL DEVICE (ARD)
Data sourced from openFDA. This site is unofficial and independent of the FDA.