FDA 510(k) clearances — page 670
clearances on record, most recent first.
Clearances — page 670
66,901–67,000 of 175,825- K042057 — INFINITY ELECTROTHERAPY SYSTEM
- K042248 — KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
- K042370 — TORAYGUIDE GUIDEWIRE
- K042385 — DOC BAND-POSTOP
- K042399 — MODIFICATION TO SHORT INTRODUCER SHEATH
- K042530 — CONSERVE PLUS HA ACETABULAR SHELLS
- K042638 — RADIANCE PORCELAIN
- K042654 — PROTECTION PLUS EARLOOP PROCEDURE MASK
- K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
- K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
- K042783 — ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
- K042787 — IS 40 MICROMOTOR
- K042847 — SYSTEMP.CEM
- K042878 — FLEXITIME XTREME
- K042923 — MD-6W WIRELESS CRITICAL DATA VIEWER
- K042943 — NOUVAG AG - VACUSON 40 AND VACUSON 60
- K043077 — MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
- K043119 — AMELOGEN PLUS
- K043177 — CLEAFIL DC CORE AUTOMIX
- K043181 — MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
- K043293 — MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U
- K043307 — CRANEX D
- K043319 — CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
- K043320 — MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
- K043355 — SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
- K043366 — PERMACOL SURGICAL IMPLANT
- K033266 — VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS
- K040270 — OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
- K041679 — COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT
- K042239 — FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
- K042349 — EMG MODEL SUA01 SUCTION UNIT
- K042805 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
- K043258 — MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
- K031425 — GENTLEWAVES LED PHOTOMODULATION DEVICE
- K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250
- K042379 — ANEMIAPRO SELF-SCREENER
- K042386 — DIRECT DIGITIZER, REGIUS MODEL 190
- K042863 — SCENIUM
- K043087 — SOMATOM CARE CONTRAST CT
- K043098 — GERBER DOUBLE ELECTRIC BREAST PUMP
- K043131 — TORPICALGIN
- K043153 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
- K043333 — VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
- K043350 — MISTAR, MODEL V3.2
- K032830 — PLLA CANNULATED INTERFERENCE SCREW
- K040671 — EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
- K041011 — ULTRALIGHT II ND:YAG LASER SYSTEM
- K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
- K042552 — BIO-CORE INTERFERENCE SCREW
- K042584 — OPUS MINIMAGNUM ANCHOR WITH INSERTER
- K042592 — INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
- K042636 — BIOPLUS
- K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
- K042820 — SYSTEMP.C&B PLUS
- K042962 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K043190 — SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K043337 — ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
- DEN040010 — VYSIS AUTOVYSION SYSTEM
- K033973 — OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
- K041238 — HELICOBACTER PYLORI IGG ELISA
- K041364 — ML830 LASER SYSTEM
- K041623 — REUSABLE STERILCONTAINER FILTER MODEL #JK090
- K042392 — DAPTOMYCIN
- K042489 — 6F Z4 GUIDE CATHETER
- K042532 — BIOCARE SYSTEMS PREMIR 818
- K042772 — EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE
- K042963 — VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
- K043062 — MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
- K043092 — PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
- K043134 — METRX WORKSTATION
- K043148 — ALL FLOW PULMONARY FUNCTION FILTER
- K043278 — TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
- K043332 — WHEELCHAIR, MODEL 8500-II
- K032825 — VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
- K041553 — ARTHREX SUTURE GRAFTING KIT
- K041833 — CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
- K042099 — TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
- K042111 — PROMEDICAL SURGICAL GOWNS
- K042131 — PROMEDICAL SURGICAL DRAPES
- K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
- K042285 — UNICRYL M
- K042461 — KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
- K042679 — IR VIEWER
- K042687 — ENZYGNOST F+2 (MONOCLONAL) TEST KIT
- K042784 — MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
- K042873 — ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
- K043114 — KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
- K043164 — PANALIGHT-BLU, MODEL 4175
- K043227 — PERIARTICULAR LOCKING PLATES, 2358 SERIES
- K043287 — PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000
- K043298 — BLUE ORTHOCORD SUTURE
- K043299 — MEDLEY PCA MODULE, MODEL 8120
- K041477 — PATHFINDER
- K042318 — AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
- K042413 — ACS MODEL NCP-2
- K042454 — STRYKER CASSETTE PUMP
- K042588 — CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
- K042689 — NICHOLS ADVANTAGE CORTISOL
- K042838 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II
- K043030 — MAGNETOM C! MR SYSTEM
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