FDA 510(k) clearances — page 960
clearances on record, most recent first.
Clearances — page 960
95,901–96,000 of 175,890- K962914 — REP 3 QUTO-FLUR CHOLESTEROL-30
- K963092 — MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER
- K963663 — 11F GUIDING CATHETER
- K964331 — ASC HIGH PRESSURE BRAIDED TUBES
- K964348 — AIA-PACK B12 ASSAY
- K964403 — SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
- K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES
- K964587 — VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
- K964682 — SKYWAY
- K964940 — TAOS 28
- K964941 — EL DORADO 40
- K964948 — AURORA 52 (PM-01)
- K964949 — AURORA 53
- K964950 — LA PLATA 28 (PM-28)
- K965171 — LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
- K955384 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
- K960966 — HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
- K962001 — MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
- K962100 — VOLMETRIC COINCIDENCE DETECTION SYSTEM
- K962239 — SMART ADJUSTER (SA201)
- K962249 — PIXELL MRI SYSTEM
- K962320 — S3 CARDIOPLEGIA CONTROL
- K962683 — SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
- K962902 — FOTONA SKINLIGHT LASER SYSTEM
- K962983 — STERILE SOFT-TEMP
- K962995 — ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
- K963221 — OPTICAL DIGITIZER OPTION FOR VIEW POINT
- K963674 — LUMEX AIR
- K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
- K964078 — 3050 SPORT-NEB
- K964130 — AEROGEAR ASTHMA ACTION KIT
- K964136 — HYSTERO CO2-PNEU 2221
- K964138 — VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
- K964274 — WRITESTAR, AND VIEWSTAR
- K964318 — PHILIPS TOMOSCAN AV EXPANDER UPGRADE
- K964324 — MULTITAK SS SUTURE SYSTEM
- K964340 — PORTAREM-3000, PFS-6000
- K964370 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
- K964450 — SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
- K964505 — GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
- K964576 — PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
- K964580 — CAP-AID (IMPROVED)
- K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE
- K965080 — ANSPACH MICROMAX SYSTEM
- K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
- K955393 — NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
- K960121 — AUTOLINK BODY PLETHYSMOGRAPH
- K962965 — LIGHTSTIC MODEL 360
- K962989 — AMOILS EPITHELIAL SCRUBBER
- K963091 — VOLLMAN PRONE POSITIONER
- K963109 — HERITAGE HIP SYSTEM
- K963357 — MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
- K963506 — TENET RADIOLUCENT HAND TABLE
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.