FDA 510(k) clearances — page 983
clearances on record, most recent first.
Clearances — page 983
98,201–98,300 of 175,890- K961010 — ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD
- K961238 — MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
- K961331 — BAGRIGHT RESPOSABLE CHILD RESUSCITATOR
- K961332 — BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
- K961335 — GEM PREMIER PLUS MODEL 5500
- K961350 — SYNTHES MINI EXTERNAL FIXATOR
- K961369 — BAGRIGHT RESPOSABLE RESUSCITATOR
- K961433 — EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
- K961496 — R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
- K961497 — PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
- K961511 — HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
- K961868 — RESPOSABLE CHILD RESUSCITATOR
- K961882 — RESPOSABLE INFANT RESUSCITATOR
- K961911 — DSL ACTIVE I-HCG ELISA
- K961938 — STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
- K961971 — Q-5000
- K962234 — STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
- K953339 — BONESOURCE HYDROXYAPATITE CEMENT (HAC)
- K953590 — COMFIT
- K953911 — PHILIPS EASYVISION
- K955495 — RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
- K955918 — SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE
- K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
- K960307 — INDEX SHOE
- K960478 — ACCUMETER H. PYLORI TEST
- K960496 — LIBERTY LITE PFS SYSTEM
- K960746 — SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
- K961230 — EASTERCLAVE
- K961251 — PUNCTUR-GUARD WINGED SET
- K961267 — PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE
- K961271 — USCI COMMANDER SERIES GUIDE WIRES
- K961306 — DELTATALKER WITH INFRARED
- K961310 — STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
- K961404 — MX960 REUSABLE PRESSURE TRANSDUCER
- K961462 — CEDIA THEOPHYLLINE ASSAY
- K961516 — LASER PERIPHERALS INC. BARE FIBER
- K961690 — CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
- K961840 — RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
- K961878 — SHARPS-TAINER
- K942867 — CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
- K953741 — THERMACYL BLOOD/FLUID WARMER
- K954572 — MAESTRO CLINICAL REMOTE CONTROL
- K961169 — RHEUMATOID FACTOR LATEX SLIDE TEST KIT
- K961222 — EVRON GEL
- K961232 — 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP
- K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
- K961421 — SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
- K961461 — DANESHVAR'S DEVICE (MODIFICATION)
- K961494 — SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
- K961495 — HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
- K961910 — VIVAGLASS FIL
- K961995 — QUICKSPLINT
- K962160 — MPM HYDROGEL DRESSING (NON-STERILE)
- K962165 — COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
- K962235 — VITROS SPECIALTY DILUENT
- K962297 — VIVAGLASS CEM
- K953948 — SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
- K955853 — HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM
- K961199 — BOSWORTH TEMPORARY RESIN
- K961390 — ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
- K961657 — CIBA CORNING 400 SYSTEM
- K962035 — GE STERILE ARTHROGRAM TRAY
- K962040 — RNS ARTHROGRAM TRAY
- K933705 — LAMINOSS DENTAL IMPLANT
- K943657 — STERILIZATION
- K954281 — PANASIL IMPRESSION MATERIAL
- K955102 — BIODATA TESTOSTERONE MAIA KIT
- K961317 — SYPHILIS IGM HUMAN SERUM CONTROLS
- K961567 — ES-3840, VIDEO SIGMOIDOSCOPE
- K961569 — DALL-MILES STAINLESS STEEL BEADED CABLE
- K961570 — KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
- K961965 — SURE CHECK PREGNANCY TEST
- K962021 — CIBA CORNING 348 SYSTEM
- K962169 — MAGNETO EYEWEAR
- K950670 — IMMULITE HERPES I AND II IGG
- K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT
- K953551 — KNOW-RECIRC
- K953649 — DISPOSABLE ECG ELECTRODE
- K954514 — UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
- K954792 — LUMISCOPE MODEL 2018 THERMOMETER
- K955489 — CALIBRATION SERUM LEVEL 1 & 2
- K955648 — K-Y PERSONAL LUBRICANT
- K960303 — FENNING FEMORAL COMPONENT
- K960386 — HANDSAFE
- K960978 — WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)
- K961171 — HUMPHREY OCT SCANNER
- K961174 — ECG MONITOR MODEL DS-3130/3140
- K961180 — NMI ANTEGRAD CARDIOPLEGIA CANNULA
- K961181 — NMI VEIN GRAFT PERFUSION SET
- K961197 — SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES
- K961219 — PERCUTANEOUS INTRODUCER SYSTEM
- K961225 — CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
- K961282 — GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
- K961326 — EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
- K961337 — EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
- K961436 — ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
- K961694 — IMPACT
- K961749 — TRANSAMERICA ELECTRODE
- K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
- K962041 — ACS LH2 IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.