FDA 510(k) clearances — page 968
clearances on record, most recent first.
Clearances — page 968
96,701–96,800 of 176,637- K964133 — AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
- K964143 — MINI-SYMM BIPOLAR COAGULATOR
- K964179 — SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS
- K964259 — SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
- K964290 — EYECHEK
- K964321 — GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)
- K964338 — RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
- K964602 — DAVIS BAYONET ELECTRODES
- K964620 — PANOGAUZE NON-WOVEN HYDROGEL DRESSING
- K964643 — SURETEMP
- K964912 — LACTATE DEHYDROGENASE
- K965084 — VIDAS PROESTERONE (PRG) (30 409)
- K961235 — SIRIUS 180, 180L, 230, 230L
- K963760 — NON-SHIELDED SURGICAL TROCAR AND SLEEVE
- K963919 — LSI VIDEOSCOPIC DISPLAY SYSTEM
- K964076 — LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES
- K964080 — LORI HEARING AID SIMULATOR
- K964122 — HP STAR ST AND ARRHHYTHMIA SOFTWARE
- K964218 — PERFECTA PLASMA SPRAY HIP STEM
- K964273 — DURA-BOARD ARMBOARD
- K964547 — DEGANIA SILICONE INDENTI LOOPS
- K965037 — CELL RECOVERY SYSTEM
- K960995 — CPR BIO-BARRIER FACESHEILD
- K962585 — UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
- K962978 — CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
- K963620 — 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
- K963975 — VERSATEC 310 ELECTRODE
- K964012 — GENIE PROCESSING AND REVIEW WORKSTATION
- K954731 — OXYLOG 2
- K962305 — CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
- K962768 — CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
- K963595 — SERAGARD VASCULAR ACCESS DEVICE
- K963672 — MODEL 90022 ROLLING STAND
- K964048 — FIRST MIDCATH CATHETER KIT
- K964049 — FIRST MIDCATH CATHETER WITH DUAL LUMENS
- K964050 — FIRST MIDCATH CATHETER
- K964103 — OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
- K964192 — ARDENT NON GAMMA-2 70
- K964284 — STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
- K961400 — RFA-300, LDA UTILITY
- K962443 — N95 FILTERING FACEPIECE
- K963467 — ROLL BELTS
- K964165 — MICRO21 WITH NDNA
- K964326 — VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
- K964559 — PORTSMART NEEDLE DE-ACCESS ENCLOSURE
- K964777 — TZ
- K962074 — VM PLUS PEAK FLOWMETER
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.