FDA 510(k) clearances — page 961
clearances on record, most recent first.
Clearances — page 961
96,001–96,100 of 175,890- K962662 — VINGMED SOUND COLOR FLOW MAPPING SYSTEM
- K963255 — PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
- K963403 — ACURAY DIGITAL X-RAY
- K964197 — IMPRA CARBOFLO EPTFE VASCULAR GRAFT
- K964798 — PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
- K964809 — SPETEMP EF
- K963184 — OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
- K963951 — AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
- K964006 — INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
- K964016 — TIELLE HYDROPOLYMER FOAM DRESSING
- K964057 — INCARE HOT/ICE SYSTEM SHOULDER BLANKET
- K964070 — DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
- K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
- K964134 — TRUS<T>LIFT PORCH LIFT
- K964145 — ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
- K964411 — TAKI ACUPUNCTURE NEEDLES
- K964515 — ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
- K955425 — DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
- K955661 — ACU-HALT
- K960999 — ISOLATION GOWN
- K961342 — SHOE COVER, NON-STERILE
- K964120 — INJECTO FLUSH
- K964177 — KROMALGIN IMPRESSION MATERIAL
- K964545 — POWDER FREE VINYL EXAMINATION GLOVE
- K964563 — OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
- K953111 — CORAIL
- K961992 — NEEDLE'S EYE SNARE
- K962309 — ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
- K962486 — DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
- K963985 — UM-D3000/UM-D4000
- K964008 — FOUNDATION KNEE SYSTEM
- K964150 — WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
- K964163 — TRIMAX NAIL SYSTEM
- K964262 — EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
- K961405 — ALBA HEALTH PAS WRAP SYSTEM
- K962037 — IMAGEN RESPIRATORY SCREEN
- K962418 — UREA NITROGEN (BUN) LIQUI-UV
- K962435 — STC AUTO-LYTE URINARY GLUCOSE ASSAY
- K963938 — MODEL 5500 CEAS
- K964669 — MIRACLE-EAR OR AUDIOTONE
- K960915 — CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
- K961209 — BRIO AUTOMATIC SAMPLINC UNIT
- K961780 — HEMODIALYSIS INTRODUCER SET
- K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
- K963847 — WAKO DIRECT HDL-C
- K963972 — NEO-CARE DUAL LUMEN UMBILICAL CATHETER
- K964060 — COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
- K964116 — QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K964637 — CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
- K940242 — VENTANA CEA PRIMARY ANTIBODY
- K960492 — SI CONTROLLER MODEL SI 500
- K960854 — SIEMENS SERVO ULTRA NEBULIZER 345
- K960948 — SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
- K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
- K961601 — H.A.M. APPLICATOR
- K962093 — ULTRAMIX
- K962138 — FLEXART V3.1 SOFTWARE
- K962226 — PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
- K962840 — ECOLOTION TRANSMISSION AND MASSAGE LOTION
- K962976 — PHARMACIA CAP SYSTEM RAST FEIA
- K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
- K963699 — BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
- K963762 — CORNEAL TOPOGRAPHER 200
- K963795 — VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH
- K963860 — THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM
- K963952 — SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
- K963980 — PHILIPS EASYVISION
- K964031 — DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
- K964125 — CONVERTORS DRAPE MATERIAL
- K964196 — CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
- K964376 — CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
- K964453 — REP 3 FLUR SPE-60 KIT
- K964471 — REP FLUR CHOLESTEROL-60 KIT
- K964618 — CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
- K964659 — ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
- K964794 — DAHLBERG K-AMP BTE
- K952721 — RUBASCAN CARD TEST
- K953269 — SAFECIRCUIT MANIFOLD/PULMONARY UNIT
- K955265 — CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER
- K955324 — BIPAP S/T-D 30 SYSTEM
- K961013 — DISPOSABLE NEEDLE ELECTRODE
- K962148 — VERGE VIDEOMETER
- K962424 — NPB-4000
- K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
- K962928 — COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
- K963417 — VITLITE (TR7700)
- K963825 — AUTO SUTURE* ABBI* SYSTEM
- K963837 — HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN
- K963960 — KSEA UNIMAT PLUS
- K964215 — ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
- K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
- K964443 — SURGIFORM ANATOMICAL MALAR
- K964519 — CURITY THORACENTESIS TRAY
- K964621 — A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
- K964774 — PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
- K964788 — EL DORADO 55
- K964789 — LA PLATA 39
- K964792 — LA PLATA 40
- K964837 — PACIFIC 56 (CB-40)
- K964838 — PALLADIA 85 (PM-13)
Data sourced from openFDA. This site is unofficial and independent of the FDA.