FDA 510(k) clearances — page 662
clearances on record, most recent first.
Clearances — page 662
66,101–66,200 of 176,637- K051551 — SMALL INTESTINAL VIDEOSCOPE SYSTEM
- K051560 — NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
- K042630 — REVLIGHT SKIN CARE SYSTEM
- K042939 — CAPILLARY'S IMMUNOTYPING (PN 2100)
- K050036 — FES CYCLE ERGOMETER, MODEL RT300-S
- K050236 — FISHVIEW
- K050500 — FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
- K050779 — CYNERGY MULTIPLEX LASER
- K051331 — 19-INCH (48 CM) COLOR LCD MONITOR CDL1902A
- K050434 — SHL DISPOSABLE AUTOINJECTOR
- K050525 — NXSTAGE SYSTEM ONE
- K050877 — CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
- K050936 — ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
- K051088 — MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
- K051204 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML
- K051395 — LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
- K051462 — MODIFICATION TO: CERCON BASE
- K051464 — PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
- K051475 — ZOLL M SERIES 12SL ANALYSIS OPTION
- K051546 — BPCALIBRATOR MC3000/MC3100
- K041177 — SYNTHACER; SYNTRICER
- K050424 — ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
- K050844 — 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL
- K050903 — XAWEX G 100
- K051202 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K051243 — JET BLUE BITE
- K051283 — MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
- K051345 — COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)
- K051349 — 3.0T PROSTATE IMAGING SYSTEM
- K051363 — RESTORATION MODULAR SYSTEM
- K051374 — CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
- K051415 — ENDOTINE RIBBON
- K050830 — ZODIAC SPINAL FIXATION SYSTEM
- K050852 — CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
- K051254 — PERIPHERAL CUTTING BALLOON
- K051284 — MD TURBO
- K051425 — NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
- K051499 — INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
- K050056 — MODEL 2500A PALMSAT PULSE OXIMETER
- K050583 — MODEL 250 SERIES MATERNAL/FETAL MONITOR
- K050860 — GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
- K051148 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K051183 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML
- K051207 — CAVEX ORTHOTRACE
- K051233 — OMRON MODEL 514N TYMPANIC THERMOMETER
- K051335 — ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
- K051483 — KODAK DIRECTVIEW DR SYSTEM DETECTOR
- K051502 — SPI DENTAL IMPLANT
- K051519 — FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
- K043314 — MANZI CLEANER SYSTEM
- K050805 — 30 ML OR 60 ML PEDI-SYRINGE FILTER
- K050995 — REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER
- K051021 — ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
- K051154 — POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K051317 — POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR
- K051367 — PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
- K051444 — SENTINEL CHOLINESTERASE LIQUID
- K051563 — NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED
- K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
- K043176 — ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
- K050156 — WHS-1000 WOUND HEALING SYSTEM
- K050445 — AMS COLLAGEN DERMAL MATRIX
- K050456 — MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
- K050696 — MEDLITE C1 Q-SWITCHED ND:YAG LASER
- K050847 — IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
- K050864 — PARALLAX ACRYLIC RESIN WITH TRACERS TA
- K051196 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
- K051245 — POLYFORM SYNTHETIC MESH
- K051286 — ZODIAC SPINAL FIXATION SYSTEM
- K051292 — ELECSYS RBC FOLATE HEMOLYZED REAGENT
- K051306 — HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
- K051318 — POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
- K051379 — PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
- K051383 — THE INCOURAGE SYSTEM
- K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
- K051500 — FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A
- K042686 — ENERGEX
- K050910 — ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
- K051007 — ACCU02 SYSTEM
- K051247 — SONOTIP II ULTRASOUND NEEDLE SYSTEM
- K051361 — EASY CORE DETACHABLE BIOPSY SYSTEM
- K051414 — EYE CUP, STERILE 1 AND NON STERILE
- K051416 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
- K051449 — GE VIVID 7 WITH OR WITHOUT SUFFIX
- K051504 — SPYSCOPE ACCESS AND DELIVERY CATHETER
- K042084 — BIODERM SCIENCES WOUND HEALING SPRAY
- K050370 — PALOMAR LUXIR HANDPIECE
- K050374 — ADVIA IMS LITHIUM ASSAY
- K050478 — MEDICON IMF-ORION SCREWS
- K050523 — DIADEXUS PLAC TEST
- K050759 — BIPAP AUTO
- K050931 — 6 FR DL POWERPICC CATHETER
- K050998 — CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
- K051008 — SET
- K051109 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML
- K051267 — GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
- K051315 — MODIFICATION TO: SECTRA IDS5 WORKSTATION
- K051319 — LYSUS INFUSION SYSTEM
- K051325 — WEBPAX, MODEL 200
- K051326 — SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.