FDA 510(k) clearances — page 1062
clearances on record, most recent first.
Clearances — page 1062
106,101–106,200 of 175,890- K935399 — RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
- K940006 — IMMULITE THIRD GENERATION (MODIFICATION)
- K940716 — OREX
- K940764 — OREX
- K940765 — ISOLYSER
- K940766 — OREX (18X18 X-RAY DETECTABLE)
- K940767 — OREX (12X12 X-RAY DETECTABLE)
- K941564 — IMMULITE ALATOP ALLERGY SCREEN
- K941595 — MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5
- K941650 — TOTAL TOE SYSTEM II
- K942384 — ENDURANCE R3000
- K942935 — ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE
- K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
- K943522 — THE PROMPT GUIDWIRE
- K943523 — ANTERIOR CERVIAL PLATING SYSTEM
- K943549 — RESTORATION ACETABULAR CUP
- K943839 — STERMED NON-CHLORINATED POWDER FREE GLOVES
- K944211 — IMMULITE PROGESTERONE
- K944275 — DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
- K944285 — OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS
- K944506 — AXSYM DIGOXIN
- K944731 — ABBOTT IMX 2 ANALYZER
- K944814 — CORVAC PLASTIC BLOOD COLLECTION TUBE
- K944854 — STERISURE STERILIZATION WRAP
- K944895 — BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
- K945650 — SPIFFY
- K921871 — HYSTEROMAT(TM) 3700
- K925678 — ATHENA HIGH SPEED HANDPIECE
- K926312 — INFRARED EYE MOVEMENT MONITOR
- K930536 — NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
- K933391 — ATRIUM'S HYBRID PTFE
- K934572 — UNITONE
- K935913 — HOWMEDICA SENTRY S TOTAL HIP SYSTEM
- K940198 — L-CATH CONNECTOR ASSEMBLY
- K941162 — HYPERGRAPH
- K941425 — ALAMAR ANTIBIOTIC SUSCEPTIBILITY
- K941838 — MULTIPLE CO2 LAERS
- K942447 — HASSON OPEN LAPAROSCOPY CANNULA
- K942743 — VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT
- K942787 — BONE ANCHOR
- K942902 — SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER
- K943256 — CARDIAC OUTPUT OPTION 39
- K943268 — SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
- K943406 — RF DRIVER, RADIO FREQUENCY DRIVER
- K943415 — MERIT (O.1T MR SYSTEM)
- K943476 — GIP/MEDI-GLOBE GOREIGN BODY GRASPERS
- K943589 — STRYKER TOTAL PERFORMANCE SYSTEM
- K944139 — DENTAL HYGIENE TRAY
- K944221 — VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED
- K944235 — ADVANCE CORP. SUNGLASSES
- K944297 — KARL STORZ INSULATED SCISSORS
- K944300 — KARL STORZ INSULATED BIOPSY FORCEPS
- K944319 — BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM
- K944398 — SUNGLASSES
- K944421 — E.COLI 0157 LATEX TEST
- K944474 — OPTILITE V FIBEROPTIC ACCESSORIES
- K944523 — HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER
- K944575 — AQUAFRESH PLAQUE FIGHTING GUM
- K944603 — CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
- K944845 — ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT
- K944857 — GOGGLE SAFEGUARD
- K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT
- K944880 — BODILY FLUID DISPOSAL KIT
- K945173 — PULPDENT HARDSHELL
- K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES
- K945238 — MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
- K945392 — SPECTACLE FRAME
- K945563 — CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))
- K945751 — KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
- K945770 — OPTICAL FRAMES
- K945970 — INSUFFLATOR FILTER TUBING SET
- K935587 — MULTILINK SHOULDER CPM UNIT
- K941171 — TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K942286 — DIARLEX ROTA-ADENO
- K942434 — BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER
- K942826 — ORTHODONITC METAL REINFORCED PLASTIC BRACKET
- K942911 — GLYCAR TISSUE REPAIR PATCH
- K943016 — ADOBE C.I.C
- K943740 — ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
- K943794 — MX4000
- K944848 — THE VIVACARE T.P.S. PROBE
- K944973 — NRF SYSTEM
- K945018 — PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL
- K945055 — HARKEN ASSURE SELF-SEAL STERILIZATION POUCH
- K945056 — PULPDENT RESIN CEMENT
- K945057 — PULPDENT HYBRID ANTERIOR COMPOSITE
- K945058 — PULPDENT MICROFILLED ANTERIOR COMPOSITE
- K945112 — PULPDENT DUAL CURE UNFILLED BONDING RESIN
- K945113 — PULPDENT CERVICAL RESTORATIVE
- K945272 — RHODIUM FILTER
- K945273 — PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2
- K945274 — PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80
- K945275 — PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1
- K945276 — PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G
- K945278 — PHILIPS BUCKY DIAGNOST FAMILY
- K945708 — SII 360 MS
- K945709 — SII 525 MS
- K932521 — POWDERFREE LATEX EXAMINATION GLOVES
- K933846 — ANGIOGRAPHY SYRINGE KITS
- K941902 — MODEL 3471 CLINICAL REFRACTOMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.