FDA 510(k) clearances — page 865
clearances on record, most recent first.
Clearances — page 865
86,401–86,500 of 175,890- K991599 — CADD ADMINISTRATION SET
- K991675 — MODIFICATION OF: STERRAD BI TEST PACK
- K991811 — CORDIS MAXI DS PTA BALLOON CATHETER
- K991855 — CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
- K984576 — K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K
- K990859 — DEFLECTABLE TAC ELECTROTHERMAL PROBE
- K990877 — HISTOFREEZER DEVICE
- K990956 — BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
- K991307 — TELEMEDICINE 2000
- K991758 — MONOJECT INSULIN SYRINGE
- K982448 — CARDIOLIGHT
- K983791 — PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
- K990183 — IMPLEX ALUMINA FEMORAL HEAD
- K990852 — COOPERSURGICAL INFRARED COAGULATOR
- K990864 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
- K990905 — PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
- K991002 — PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
- K991143 — MAGNA-ROM 21 KNEE SYSTEEM
- K991178 — FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253
- K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
- K991407 — SYNTHES LOCKING CALCANEAL PLATES
- K991447 — CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
- K991630 — ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
- K991686 — LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)
- K991824 — AT HOME DRUG TEST, MODEL 9171
- K991831 — BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
- K991842 — SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING
- K980438 — 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
- K990246 — STERI-PAK LF BOWIE-DICK TEST PACK
- K990846 — AMORPHOUS DIAMOND COATED DRILL
- K990871 — PILLOWPOSITIVE CERVICAL PILLOW
- K990920 — DRG TITANIUM BONE PLATE
- K991099 — AMERICAN DENTAL PRODUCTS ETCH-DETECT
- K991113 — `INEAR WRIST COIL, MODEL 440GE-09
- K991127 — VARIANT II B-THALASSEMIA
- K991166 — K-ASSAY MICROALBUMIN CALIBRATOR SET
- K991418 — BROWNE MVI ETHYLENE OXIDE INDICATOR
- K991467 — K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
- K983839 — BIOTEST ANTI-EBV RECOMBINANT
- K983841 — BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
- K983842 — BIOTEST ANTI-EBV RECOMBINANT, EA IGM
- K983867 — FUJI CATHETER, MODEL CTH001
- K984235 — INTERSOURCE 125, MODEL 1251L
- K990063 — NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
- K990243 — FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES
- K990809 — CADISCOPE ELECTRONIC STETHOSCOPE
- K990909 — MTP UROPUMP DISPOSABLE TUBING SET
- K990912 — MTP EXTRACTION BAG
- K990954 — ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
- K990974 — VITOP DRESSING
- K991003 — PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI
- K991077 — MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
- K991086 — CAPNOCHECK II, MODEL 8400
- K991102 — COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
- K991106 — P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
- K991183 — DORNIER LASERTRODE FIBER
- K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071
- K991301 — CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
- K991409 — K-ASSAY RHEUMATOID FACTOR
- K991410 — 3402 HANDHELD PULSE OXIMETER
- K991600 — SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
- K991604 — EPI-FOAM SILICONE SHEETING
- K991611 — GE LOGIQ 500
- K991619 — FOUNTAIN Infusion Catheter and Occluding Guide Wire
- K991734 — MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
- K991795 — IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
- K991796 — IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
- K991797 — IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
- K983511 — SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
- K983629 — RPM RESPIRATORY GATING SYSTEM
- K983713 — PRODIMED MICROINJECTION PIPETTES
- K983987 — AMIGO MODEL 590000
- K984562 — VIVOSONIC
- K990795 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES
- K990801 — MINIMED 508 INSULIN PUMP
- K990833 — DOSE CALC, MODEL VS. 1.02
- K990913 — HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
- K991115 — LINEAR SHOULDER COIL, MODEL 414GE-09
- K991163 — VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
- K991288 — DISTENDER SERIES II BAROSTAT
- K991553 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
- K991643 — IDS4 V3.2 IMAGE DISPLAY SYSTEM
- K982961 — MEDIPOINT
- K983984 — COOLTOUCH V ND:YAG
- K990814 — CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
- K990869 — LEICA AT550
- K990966 — MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS
- K991773 — HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
- K973844 — GASTRIC AND RECTAL CATHETERS
- K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT
- K983296 — AUTO SUTURE ABBI SYSTEM
- K983308 — RC CORNET, MODEL #44F50
- K984374 — SURGISORB
- K990202 — SUGITA TITANIUM ANEURYSM CLIP
- K990743 — SOLO ORTHO
- K991202 — MODIFICATION TO WOUN'DRES
- K991660 — COPALIS MULTIPLEX EBV ANTIBODY ASSAY
- K981860 — A P HARNESS
- K983996 — SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
- K984035 — XK-95 HIGH SPEED MOTOR DRILL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.