FDA 510(k) clearances — page 675
clearances on record, most recent first.
Clearances — page 675
67,401–67,500 of 176,637- K043430 — 20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB
- K043483 — RADIN, MODEL V 3.0
- K043487 — EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
- K043504 — PALAIMPACT
- K043607 — BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
- K050099 — SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
- K042129 — F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK
- K042623 — AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
- K042650 — BIOMOVE 3000
- K042818 — PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
- K042973 — SOLITUDE UNIPOLAR HEAD
- K043071 — RANDOX PHENCYCLIDINE ASSAY
- K043072 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
- K043471 — FUSION FAST
- K043550 — AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
- K043564 — HORIZON ANGIO CATHLAB
- K050027 — LAPAROCISION SCOPE CONTROLLER SYSTEM
- K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT
- K041031 — CARDIOSTATION-100 (CS-100)
- K042596 — LSA HELIUM
- K043065 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
- K043264 — LDL-EX SEIKEN ASSAY KIT
- K043309 — GEODESIC PHOTOGRAMMETRY SYSTEM
- K043326 — BEWELL, MODEL SC 20
- K043583 — CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
- K043596 — THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
- K040685 — Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
- K041642 — V.A.C. GRANUFOAM SILVER DRESSING
- K042160 — SONOSURG TROCAR
- K042578 — I-PROMOTIONS CONTACT LENS CASE
- K042594 — VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
- K043301 — GC TION GINGIVAL PROTECTOR
- K043530 — DVI CURING LIGHT
- K043568 — EQUESTRA FLUID DELIVERY SYSTEM
- K043588 — MYLAB 15 / MYLAB 20, MODEL 2700
- K050005 — INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
- K050035 — ELEKTA NEUROMAG WITH MAXWELL FILTER
- K042924 — ARCHITECT STAT MYO IMMUNOASSAY
- K043118 — HYDROGUM SOFT
- K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES
- K043396 — INTEGRITY, MODEL V500
- K034009 — LAPEX 2000
- K041920 — INFINITY PLUS ELECTROTHERAPY SYSTEM
- K042082 — AIRSTRIP OB
- K042315 — CEREBRAL STATE MONITOR - CSM
- K042486 — PROCEDUR 10 SYRINGE DEVICE
- K042487 — PROCEDUR SF SAFETY SYRINGE DEVICE
- K042774 — MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
- K042885 — OCT-OPTHALMOSCOPE
- K043102 — MULTI-USE COMPRESSION SCREW
- K043113 — TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
- K043206 — PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
- K043271 — R2-MRI ANALYSIS SYSTEM
- K043336 — OPTISTRAND, MODEL 1032S
- K043389 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML
- K043415 — CENTRICITY PACS SYSTEM
- K043514 — ALLOGRAN-N-BONE VOID FILLER
- K043534 — MODIFICATION TO OUTBACK CATHETER
- K043549 — INFINITY GATEWAY SUITE, VF4
- K043560 — PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
- K043582 — OCEAN CHEST DRAIN
- K042108 — VISTA PLUS
- K042536 — MASIMO SET RAD 57 PULSE CO-OXIMETER
- K042628 — MODIFICATION TO: RADIANALYZER, MODEL 12711
- K042745 — LIFESCREEN APNEA
- K042961 — SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
- K043060 — OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
- K043106 — PINN-ACL CROSSPIN
- K043215 — FLOWCARE PLG CD4 REAGENT
- K043281 — CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
- K043382 — TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
- K043508 — DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
- K040103 — SOUNDSKIN PHOTOTHERAPY SYSTEM
- K040625 — ATAD ARD CATHETER
- K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
- K042898 — PANTHERA N POWDER FREE BLACK NITRILE GLOVES
- K043039 — SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
- K043059 — COMPRESSION STAPLE AND SIMPLE STAPLE
- K043472 — MEDIN TECH ZIRCONIA-CP10, SS1000
- K043546 — DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
- K033900 — X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
- K042168 — CONCORD Radiopaque Bone Cement
- K042455 — DEVILBISS NASAL CPAP MASK, 9354 SERIES
- K042971 — TITAN DENTAL IMPLANT SYSTEM
- K043252 — CABLING SYSTEM TROCHANTER HOOK
- K043263 — TRIMED OSTEOTOMY PLATE
- K043304 — Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
- K043402 — THERMAGE THERMACOOL SYSTEM
- K043502 — 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
- K043522 — ISSYS PEDICLE SCREW SYSTEM
- K043536 — NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
- K043537 — TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
- K043554 — ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
- K041086 — PALOMAR STARLUX PULSED LIGHT SYSTEM
- K041667 — SAN-MAR LABS LUBRICATING JELLY
- K041717 — POWERSTICK MALE LATEX CONDOMS
- K041736 — PFA PATCH
- K041879 — PALOMAR LUX1064 HANDPIECE
- K042254 — PMP4 SELFCHECK ECG
- K042345 — LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.