FDA 510(k) clearances — page 969
clearances on record, most recent first.
Clearances — page 969
96,801–96,900 of 175,890- K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
- K963287 — VACUUM CUP (004SD)
- K963526 — STRAP WEDGE
- K963740 — LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS
- K963818 — OVATION AGC-2
- K963819 — OVATION ASP
- K963820 — OVATION LINEAR
- K963821 — OVATION AGC-1
- K963822 — OVATION AGC-3
- K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE
- K953210 — GLUCOSE (HEXOKINASE) KIT
- K960010 — SERVO VENTILATOR 300 COMPUTER INTERFACE
- K960159 — CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
- K960168 — SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
- K960486 — KSEA MODEL 383320 20 ANGIOMAT
- K960571 — RAPID ELECTROPHORESIS ANALYZER
- K960985 — SLS-CT
- K961418 — OSTEOMED MSS
- K962225 — VIEWSEND MEDICAL MODEL 1200
- K962675 — STA - LIATEST VWF TEST KIT
- K962865 — REMBRANDT SYSTEM
- K962924 — PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
- K962925 — OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
- K962932 — CORDIS STABILIZER PLUS XS
- K962933 — OPART MRT-600
- K962938 — EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
- K962948 — CERALAS G ND;YAG LASER SYSTEM (CERALAS G)
- K963096 — ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
- K963173 — STEALTHSTATION SYSTEM
- K963265 — PROSYS SAMEC LA
- K963329 — ETHICON ENDOSUTURE SYSTEM
- K963395 — IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
- K963619 — GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
- K963623 — SPYROFLEX PIGMENTED WOUND DRESSING
- K963845 — MEROPENEM, 10 MCG, SENSI-DISC
- K950686 — I.V. START KIT
- K955553 — PERFECTA REVISION HIP SYSTEM
- K955882 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
- K955923 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
- K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY
- K960367 — INCSTAR RUBELLA IGG ELISA ASSAY
- K961864 — CSF/URINE TOTAL PROTEIN
- K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K962929 — PERSONAL BEST II
- K962963 — CHECKMATE ANKLE RESTRAINT SYSTEM
- K962964 — HEELBO JOHNNY GRAIT BELT SECURITY BELT
- K963107 — ETEST FOR CEFEPIME
- K963110 — JETLITE
- K963209 — PROSTYLE COMPACT
- K963514 — PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)
- K963537 — SIGMA DIAGNOSTICS BUN REAGENT
- K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT
- K963560 — MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
- K963627 — (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
- K963664 — DENTAL HANDPIECE AND ACCESSORY
- K963684 — A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
- K963710 — PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE
- K963734 — ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
- K960056 — USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
- K961247 — AS/3 LIGHT MONITOR
- K961844 — OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
- K961888 — PILLAR 4-WHEEL SCOOTER
- K962034 — SC, CEMENTLESS HIP SYSTEM
- K962268 — CHROME COBALT BALL HEAD
- K962713 — DPAP STEALTH SLEEPNET MODEL NUMBER 84000
- K962846 — EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
- K962869 — GSP1 - GAS SELECTION PANEL
- K962871 — ODS1 - HOOD DRIVER
- K962907 — SKINNY,FRANSEEN,WESCOTT NEEDLES
- K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
- K962945 — CORDIS OPTA PTA BALLOON CATHETER
- K962990 — RADIONICS SIPHON LIMITING DEVICE (SLD)
- K963213 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K963222 — MICROGYN PLUS STIMULATION DEVICE
- K963227 — WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
- K963301 — STANDARD WHEELCHAIR
- K963772 — SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
- K954651 — ELECTRODE RECORDING CATHETER
- K955470 — ACTION POTENTIAL SIMULATION THERAPY DEVICE
- K962426 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
- K962645 — ISOLA TWISTER CONNECTOR
- K962879 — SALTERLABS 8660 SERIES NEBULIZER
- K962881 — KSEA CULDOCENTESIS SET
- K963333 — OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
- K952083 — TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
- K954492 — MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
- K955299 — DPS 4 DIALYZER PREPARATION SYSTEM
- K960810 — BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
- K961126 — PULSE DOSE SERIES
- K962250 — CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
- K962611 — BARD EAGLE INFLATION DEVICE
- K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404
- K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
- K963031 — GENXCATHETER
- K963234 — STAPLE REMOVAL KIT
- K963338 — UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
- K951014 — ISOLAB'S T4 TEST KIT
- K952001 — GEON ELECTRONIC THERMOMETER
- K954994 — TRUST
- K960491 — MICRO HAEMATOCRIT CENTRIFUGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.