FDA 510(k) clearances — page 578
clearances on record, most recent first.
Clearances — page 578
57,701–57,800 of 176,542- K073686 — C.T.M. POWER CHAIR, MODEL HS-1500
- K080147 — ELECSYS PROBNP II CALCHECK
- K080242 — HEARTWAY POWER MOBILITY SCOOTER, PF7
- K080247 — QUIKCLOT NOSEBLEED
- K080295 — CHARLOTTE CLAW 3.5
- K072055 — LAVA FRAME, LAVA FRAME SHADE
- K072145 — MEDICAL GLOVE SERIES
- K072812 — PHILIPS HEARTSTART SMARTPADS III
- K073138 — CARDIQ EXPRESS VERSION 2.0
- K073153 — CARDIQ FUNCTION XPRESS
- K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K073442 — MICRUS MICROCOIL SYSTEMS
- K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
- K080144 — MANDREL GUIDEWIRES OR M-WIRES
- K080206 — MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
- K080253 — KIMBERLY-CLARK INTRODUCER KITS
- K080289 — 1500 PRO
- K080342 — NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
- K070961 — BIOMERIX SURGICAL MESH, MODEL: RCR-01
- K072860 — YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500
- K073036 — FORE-SIGHT, MC-2000 SERIES
- K073046 — ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504
- K073646 — MINITAPE URETHRAL SLING
- K062763 — NONCON ROBO PACHY F&A
- K071490 — LEONE ORTHODONTIC MINI IMPLANT
- K071896 — FOX 940, MODEL 940
- K072129 — NOBELACTIVE ZIRCONIA ABUTMENT
- K073322 — FOX 1-980, FOX Q-1064, FOX-Q-810
- K073466 — SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
- K073576 — NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
- K073596 — NEOMED SINGLE LUMEN UMBILICAL CATHETER
- K080290 — XVIEWNET
- K080333 — IMAGEGRID
- K080367 — ZIMMER MIS LIGHT
- K070259 — EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
- K071809 — ENSPLINTRX BONE FIXATION SYSTEM
- K072158 — AQUA PURE DEIONIZER EXCHANGE SERVICE
- K072223 — VINYL EXAMINATION GLOVE, POWDERED
- K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
- K073065 — OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
- K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
- K073184 — BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
- K073314 — HEANY INDUSTRIES INC DENTAL XIRCONIA
- K073375 — NEWDEAL TIBIAXYS SYSTEM
- K073460 — SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
- K073516 — DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
- K073570 — DEPUY TRI-LOCK BONE PRESERVATION STEM
- K073704 — I-DIXEL
- K080119 — CLEARSCAN
- K080320 — PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
- K080334 — INSTARAD
- K072249 — EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
- K072821 — VITREA 4DCT
- K072851 — POLYSTAR 79 DENTURE BASE RESIN
- K073232 — INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
- K073283 — GC GAM-100
- K071532 — ALPHA INFUSION PUMP, MODEL A200, A450
- K072704 — UNICOMPARTMENTAL KNEE
- K073331 — DVO EXTENDED ARTICULATION HUMERAL HEADS
- K073344 — ORTHOPEDIATRICS PLATING SYSTEM
- K073426 — APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM
- K062991 — GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
- K071596 — POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
- K071663 — VF GEL PLUS
- K071702 — BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
- K072227 — VINYL EXAMINATION GLOVE POWDER FREE
- K072382 — MODEL I-2000 MONITOR
- K072447 — PENTABORN
- K072733 — 3M ESPE ADULT CROWN
- K072856 — SPI VARIOMULTI ABUTMENT
- K073067 — ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS
- K073076 — HOFFMANN LIGHT SYSTEM
- K073245 — EXTENDED VERTIFLEX SPINAL SCREW SYSTEM
- K073282 — BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
- K073588 — GC MODELS OPA-100 AND JC-50
- K073697 — TRANSBOND SUPREME ADHESIVE
- K080113 — APEX DAL ELECTRONIC APEX LOCATOR
- K080114 — HUAYI H035 BASIC WHEELCHAIR
- K080282 — ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00
- K080288 — TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
- K070947 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER
- K072100 — GC AADVA ABUTMENT
- K072107 — PERIOSCAN, MODEL: D 3496
- K073007 — CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
- K073079 — THUMPER, MODEL: 1008
- K073154 — FACTS HAND AND PINCH GRIP COMBO
- K073194 — CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
- K073258 — ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT
- K073263 — PRO-V
- K073332 — V-RASER DIODE LASER SYSTEM
- K073419 — PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
- K073420 — BLACKSTONE ASCENT MULTIAXIAL SCREWS
- K073527 — VARIAX ELBOW SYSTEM
- K073542 — CYCLETRAC CT-5000
- K073602 — MODIFICATION TO: APEX KNEE SYSTEM
- K080074 — ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
- K080143 — MODIFICATION TO STRYKER SPINE OASYS SYSTEM
- K080234 — TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
- K072487 — FAST1 INTRAOSSEOUS INFUSION SYSTEM
- K072955 — CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)
Data sourced from openFDA. This site is unofficial and independent of the FDA.