FDA 510(k) clearances — page 666
clearances on record, most recent first.
Clearances — page 666
66,501–66,600 of 175,825- K050120 — EASY CORE BIOPSY SYSTEM II
- K050167 — CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
- K041798 — ATALIA TITANIUM SURGICAL MESH
- K042073 — OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
- K043051 — QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
- K043091 — NAVIGUS NEXDRIVE, MODEL MI-3000
- K043174 — STEALTH FUSION SYSTEM, MODEL RR 1000
- K043236 — FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
- K043316 — RABEA SPINAL IMPLANT
- K043327 — ONLINE DAT BENZODIAZEPINES PLUS
- K043384 — VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III
- K043386 — VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
- K043405 — NUVASIVE COROENT SYSTEM
- K050044 — MEDTRONIC CLIP GUN KIT
- K050090 — GEL MARK V
- K050152 — PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
- K050154 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K050155 — POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K050160 — KATANA ZIRCONIA
- K050257 — LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
- K041892 — ZOLL AED PRO EXTERNAL DEFIBRILLATOR
- K043219 — AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
- K043446 — EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
- K043499 — POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
- K043605 — INSCOPE 3-STAGE BALLOON DILATOR
- K050055 — GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
- K040318 — MEDCOMP SPLIT-CATH II
- K041224 — FOOTHILLS SURGICAL DRAPES
- K042719 — HOME HEALTH POWER WHEELCHAIR, MODEL HC-200
- K042780 — NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
- K043066 — PIONEER ANTERIOR CERVICAL PLATE SYSTEM
- K043126 — ASSIST HEADER CLEANER
- K043185 — SYNTHES 3.5MM CORTEX SCREWS
- K043200 — SIGN FIN NAIL
- K043257 — REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM
- K043321 — MODIFICATION TO: CD HORIZON SPINAL SYSTEM
- K043371 — BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
- K043469 — SYNGO INSPACE 4D
- K043517 — TRANSMITTER, ZS-940PA SERIES
- K050015 — MODIFIED ACUMEN SHEATH, MODEL TTWO767
- K050025 — NANOSS BONE VOID FILLER
- K050059 — G-LIGHT
- K050147 — TRELLIS-8 PERIPHERAL INFUSION SYSTEM
- K050161 — SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY
- K040303 — 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
- K043246 — BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
- K043369 — CERVEX-BRUSH COMBI
- K050126 — GE LOGIQ TWIN
- K031782 — GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
- K042531 — UPDATED SLIP UROLOGY INTRODUCER SHEATH
- K042804 — TESCERA OPAQUER POWDER/SCULPTING RESIN
- K043046 — COOLTOUCH, MODEL CT3S
- K043151 — MODIFICATION TO: CD HORIZON SPINAL SYSTEM
- K043152 — VERTEBRON PSS PEDICLE SCREW SYSTEM
- K043168 — BISCOVER LV
- K043233 — GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
- K043312 — NOBELRONDO DENTAL CERAMIC - ZIRCONIA
- K043323 — D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
- K043368 — VITELCARE TURTLE, MODEL 400
- K043423 — MODEL SC-3008 SEQUENTIAL CIRCULATOR
- K043475 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K043540 — HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
- K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
- K050087 — LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800
- K050102 — E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
- K050143 — OMNIPRO SYSTEM
- K041630 — ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
- K042794 — BEAM MODULATOR, MODEL 4513 332 8000
- K042937 — MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
- K043150 — AMADEUS II EPIKERATOME
- K043173 — Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
- K043270 — SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
- K043346 — GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
- K043460 — OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
- K050019 — IN EXAM INTRAORAL DENTAL X-RAY SYSTEM
- K050026 — PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
- K050049 — DYNAFLO BYPASS GRAFT
- K050069 — CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
- K050092 — R605 FACS COLLIMETER
- K050121 — ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
- K041841 — PACHYCAM
- K041992 — MEDTRONIC STRATAVARIUS
- K042112 — INFANT FEEDING TUBE
- K042278 — ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
- K042321 — MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
- K043014 — POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)
- K043274 — NEUROMONICS TINNITUS TREATMENT
- K043290 — MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.