FDA 510(k) clearances — page 1259
clearances on record, most recent first.
Clearances — page 1259
125,801–125,900 of 176,637- K903592 — ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH
- K903593 — ESPI APPLICATOR SLEEVE, #8410
- K903594 — ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201
- K903595 — ESPI CLAW FORCEP, #8302, 10MM, 30CM
- K903596 — ESPI REDUCER SLEEVE, #8415
- K903597 — ESPI MICRO SCISSORS, #8150
- K903601 — ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204
- K903602 — ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203
- K903669 — GENESIS INSUFFLATING CATHETER
- K903696 — OLYMPUS INORGANIC PHOSPHORUS
- K903744 — PHYSICIAN'S CHOICE
- K903758 — SYVA MICROTRAK EIA ACCESSORY REAGENTS
- K903818 — ARGIBOND DENTAL ALLOY FOR PORCELAIN
- K903819 — ARGISTAR 45 GOLD ALLOY FOR PORCELAIN
- K903830 — NOVABOND GOLD ALLOY FOR PORCELAIN
- K903831 — ARGICRAFT 1 PALLADIUM SILVER ALLOY FOR PORCELAIN
- K903832 — ARGICRAFT 2 PALLADIUM SILVER ALLOY FOR PORCELAIN
- K903833 — DENTABOND GOLD ALLOY FOR PORCELAIN
- K903856 — WET-NO-MORE MONITOR
- K896830 — OPTIMATE HEMOGLOBIN A1C
- K901736 — OXIMETRY PROBE CATHETERS
- K902368 — PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
- K902615 — ADG BONE PLUG
- K902621 — SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
- K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
- K895764 — MODIFIED LYOFOAM WOUND DRESSINGS
- K896068 — TIPSTOP(TM)
- K897070 — ENDOBRUSH(TM) DEVICE; OMNIBRUSH
- K900890 — NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
- K900925 — NIDEK, INC. MODEL ADC-8000 DERM
- K901127 — LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY
- K901315 — AEROMIST II NEBULIZER
- K901559 — MODIFICATION TO API UNISCEPT 20GP
- K902280 — RAD-X GLASSES
- K902589 — CYTOSET(TM)
- K902591 — CYTETTE(TM) CYTOLOGY BRUSH
- K902609 — DIRECTIGEN FLU A
- K902851 — MICROSCOPE DRAPE
- K902861 — CIBA CORNING ACS DIGOXIN IMMUNOASSAY
- K902864 — SURGICAL LIGHTING-CENTRA 450
- K902865 — BAUMER SURGICAL TABLE
- K902887 — CUSTOMED ARTHROSCOPY PACK
- K902888 — CUSTOMED ORTHOPEDIC II
- K902892 — CELL-DYN CALIBRATOR
- K903028 — GYREX 2T VERSION 2.1U.
- K903188 — ABBOTT VISION LYTE (TM) SODIUM
- K903327 — CUI ARTICULATED SILICONE CHIN
- K903328 — CUI PREMAXILLARY IMPLANT
- K903329 — CUI ANATOMICAL SILICONE MALAR
- K903383 — TDX FREE T4 CALCULATION
- K903384 — IMX FREE T4 CALCULATION
- K903510 — MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
- K903616 — DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
- K903676 — STERNOTOMY CABLE, SONGER CABLE SYSTEM
- K903764 — COMPANION 318 NASAL CPAP SYSTEM
- K903949 — FRAME, SPECTACLE
- K895810 — SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE
- K895811 — SHARGHP HYPODERMIC NEEDLE
- K895812 — SHARGHP INTRAVENOUS CATHETER
- K895980 — SHARGHP INSULIN SYRINGES
- K900425 — SURGICAL COTTON GLOVES
- K901117 — OHMEDA UNIVERSAL PAC
- K901687 — F-24 FEMORAL HIP PROSTHESIS
- K901866 — DEGUFLEX (R) CS LIGHT
- K902382 — C3C AND C4 RID KITS
- K902543 — ACID PHOSPHOTASE REAGENT TEST AND KIT
- K902561 — ROCHE COBAS READY CREATININE REAGENT
- K902731 — ENDOSCOPIC HEMOSTATIC LIGATING LOOP
- K902834 — ABBOTT IMX FREE T4
- K902976 — MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC
- K902979 — MILENIA (TM) AMPHETAMINE
- K903204 — MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL
- K903309 — ROCHE COBAS READY AMYLASE REAGENT
- K903310 — CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
- K903311 — NOVAPATH TSH ENZYME IMMUNOASSAY
- K903334 — UREA NITROGEN TEST
- K903338 — KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
- K903407 — AFFINITY HLH TEST SYSTEM
- K903432 — IMX FREE T3 CALCULATION
- K903508 — LABELLING CHANGES TO IMPRES-MB-X
- K903511 — SYNERMED TOTAL PROTEIN REAGENT KIT
- K903569 — CURITY THORACENTESIS TRAY
- K903573 — REFLOTRON CREATININE TEST TABS
- K903628 — AIA-PACK IRI
- K903704 — FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
- K903767 — ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
- K903855 — THE ON-GARD CORD-CADDY
- K901580 — PROPHY PASTE
- K901865 — DEGUFLEX MONOPHASE
- K901867 — DEGUFLEX (R) CS PUTTY
- K901940 — LUHR MICRO MESH
- K901941 — LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
- K902066 — DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES
- K902319 — BAUER TEMNO BIOPSY NEEDLE
- K902348 — SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*
- K902645 — HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
- K902646 — HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP
- K902838 — DENTURE DYNAMIC'S DENTURE MAGIC
- K902893 — TI-CORE (DENTAL COMPOSITE)
- K902911 — TITANIUM/STAINLESS STEEL INSTRUMENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.