FDA 510(k) clearances — page 653
clearances on record, most recent first.
Clearances — page 653
65,201–65,300 of 176,637- K051632 — PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
- K051879 — SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
- K052270 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML
- K052358 — ETIAM STAR PACS COMPONENTS
- K052367 — SCIENT'X CEMENT RESTRICTOR
- K052468 — YK9000 SERIES MANUAL WHEELCHAIR
- K052626 — SMARTSUCTION HARMONY DEVICE
- K052686 — ARTHROCARE ARTHROWANDS
- K043494 — MASTEL LASER CLEAN ROOM, MODEL EBS-100
- K050124 — POROUS COATED ACETABULAR COMPONENTS
- K051514 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
- K051577 — IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
- K051783 — ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
- K051943 — SUREFLOW SAFETY INFUSION DEVICE
- K052010 — HBA1C LINEARITY SET
- K052142 — QUANTA LITE GLIADIN IGG II
- K052143 — QUANTA LITE GLIADIN IGA II
- K052164 — MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
- K052190 — FETAL MONITOR, MODELS BT-300 AND BT-200
- K052430 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
- K052585 — 3T HD BREAST ARRAY
- K050286 — FIDIS CONNECTIVE 8
- K051806 — CARE FECAL OCCULT BLOOD TEST, MODEL KT313
- K051872 — MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
- K051969 — TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA
- K052193 — ISE COMPENSATOR
- K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS
- K052269 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN
- K052359 — IBL CORTISOL LIA TEST KIT
- K052516 — STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137
- K042564 — HEMOR-RITE CRYOTHERAPHY
- K050097 — TECHNO-SCOPE VISUAL STETHOSCOPE
- K051779 — ANDROFLOW - RESPIRATORY RATE MONITOR
- K051789 — VISANTE OCT
- K051913 — POWDERED LATEX PATIENT EXAMINATION GLOVES
- K051944 — FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
- K052063 — HUANQIU HEATING LAMP
- K052220 — IPLAN RT FIBERTRACKING
- K052250 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
- K052273 — POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
- K052352 — COLOR CORONIS 2MP-21 AND MFCD 2321
- K052464 — TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
- K052529 — E-2320 PA S
- K052551 — DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
- K042681 — CARTO RMT EP NAVIGATION SYSTEM
- K042998 — REFSTAR RMT EXTERNAL REFERENCE PATCH
- K043099 — LINEAGE HA ACETABULAR SHELLS
- K051332 — ADVANTA T-GRAFT
- K051569 — RINGLOC BI-POLAR ACETABULAR COMPONENT
- K051698 — MERRIES UNI-OSTEO, MODEL CS30250-CS10102
- K051701 — VICRYL * MESH BAG
- K051843 — COPELAND EAS HUMERAL RESURFACING HEADS
- K052027 — OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
- K052083 — NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
- K052311 — VITEK 2 GRAM NEGATIVE TIGECYCLINE
- K052415 — POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
- K052517 — SITE-RITE 5 ULTRASOUND SYSTEM
- K051469 — CAREVENT ATV+ AND CAREVENT MRI
- K051861 — THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777
- K051940 — CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
- K051951 — CERAMENT BONE VOID FILLER
- K052009 — CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR
- K052131 — EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
- K052232 — VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
- K052478 — MFCD 1219, MFCD 1219 TS
- K052593 — FUSION CURING LIGHT
- K052614 — LOW PROFILE PLATE AND SCREW SYSTEM
- K050327 — E-POLY (VITAMIN E) ACETABULAR LINERS
- K051404 — B-CARE POWDER FREE LATEX EXAMINATION GLOVES
- K051667 — EZ-JECT
- K051726 — ARTHREX TENODESIS FAMILY
- K051865 — TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
- K051887 — PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)
- K051895 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K052172 — HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
- K052235 — LCR
- K052309 — DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
- K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
- K052434 — HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
- K052489 — ACTIHEART
- K052542 — ACCOLADE RPS HIP STEM
- K052579 — PORTAL GRAVITY SYSTEM
- K051369 — SYRYKER SORANO WHEELCHAIR
- K051537 — HILT FAMILY LASER: HILT I, HILT II, HILT III
- K051730 — MATRIX HOLTER SYSTEM, MODEL M12
- K051741 — ACCOLADE HFX FEMORAL STEM
- K051772 — ASAHI TORNUS SUPPORT CATHETER
- K051856 — TRANS1 FACET SCREWS
- K052373 — QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
- K052418 — AXXESS BUTTERFLY ANCHOR
- K052521 — NISSIN SERIES MECHANICAL WHEELCHAIR
- K052559 — WU'S POWERED WHEELCHAIR, MAMBO 2
- K042991 — I-NEB AAD SYSTEM
- K050448 — CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
- K050518 — REPROCESSED PHACOEMUISIFICATION TIPS
- K050637 — ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
- K051048 — SURGISIS STAPLE LINE REINFORCEMENT II
- K051222 — AV-S ANAESTHESIA VENTILATOR
- K051355 — VANISHPOINT I.V. CATHETER
- K051459 — SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
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