FDA 510(k) clearances — page 949
clearances on record, most recent first.
Clearances — page 949
94,801–94,900 of 175,890- K970185 — STERILE DISPOSABLE EQUIPMENT MAGNET COVER
- K970370 — TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
- K971051 — IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
- K961790 — POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
- K962700 — VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
- K963801 — PAP BRUSH
- K964533 — EBI SPINELINK SYSTEM
- K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING
- K970200 — RELIANCE PF FEMORAL STEMS
- K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
- K970576 — SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
- K970796 — 3M RED DOT 2560 & 2570 MONITORING ELECTRODES
- K970965 — MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
- K971228 — FEMTEX 100% COTTON TAMPONS
- K962208 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
- K963755 — SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
- K963918 — IMMULITE COCAINE METABOLITE
- K963948 — MINIMED INSULIN PUMP, MODEL 505
- K964787 — MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
- K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY
- K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM
- K970218 — IS-ANTI-SSA TEST SYSTEM
- K970220 — IS-ANTI-SM TEST SYSTEM
- K970227 — IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
- K970228 — IS-ANTI-JO-1 TEST SYSTEM
- K970237 — IS-ANTI-SSB TEST SYSTEM (720-260)
- K970238 — IS-ANTI-SM/RNP (720-270)
- K970239 — IS-ANTI-SCL-70 TEST SYSTEM (720-280)
- K970250 — CLINISTRIP
- K970259 — E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
- K970265 — ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
- K970656 — HYDROFLEX
- K970856 — CARDIOISOZYME, CK/LD ISOENZYME CONTROL
- K970862 — SPINALSCOPICS
- K970921 — STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
- K970932 — ORGENTEC MICRO-ALBUMIN EIA ASSAY
- K970956 — CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5
- K971058 — DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
- K963126 — AESOP SYSTEM AND ACCESSORIES
- K970088 — RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
- K970157 — LASERSCOPE AUTOMATIC EYE PROTECTION FILTER
- K970287 — LUMBAR PUNCTURE KIT
- K970451 — DOWNSCAN 120
- K970715 — SYSTEM B HEAT SOURCE
- K945586 — FLEXIBLE DILATING SHEATH
- K960928 — SYRINGEFILTER
- K962638 — TONOCAP, TC-200 AND ACCESSORY CATHETERS
- K963076 — LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
- K964161 — HEARTPORT ENDOAORTIC CLAMP
- K964360 — VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
- K965083 — SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
- K965233 — SHARPSITE AC
- K970154 — KODAK EKTASIAN HG FILM (EHG-15)
- K970156 — IMEX FUTURALDOP PRO
- K970342 — CAVITRON JET WITH SPS SYSTEM
- K970534 — PICTURE ARCHIVING & COMMUNICATIONS DEVICE
- K970606 — COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K970626 — EASY CAM
- K971209 — CLINITEK HCG TEST STRIPS
- K961388 — ATLAS III ACETABULAR CUP
- K962627 — CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
- K962696 — PERIFIX PEDIATRIC EPIDURAL KIT
- K963330 — URODYNAMIC ANALYSIS MODULE
- K963503 — CTS MIDCAB CORONARY SHUNT
- K963616 — ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
- K963855 — 12 URETEROSCOPES/URETERO-RENOSCOPES
- K964083 — ULTRATHERM (908)
- K964970 — BIOMET BONE SCREW
- K970074 — STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
- K970095 — PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
- K970108 — HARMONIES MENSTRUAL TAMPON
- K970399 — KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
- K970462 — ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
- K970713 — COMPASS UNIVERSAL HINGE
- K952912 — SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
- K953122 — STERITEC DRY HEAT INDICATOR LABEL
- K954120 — MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR
- K961260 — KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
- K963613 — IMMULITE RUBELLA IGG
- K963631 — SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
- K963716 — MICS DEVICE SYSTEM
- K964038 — CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
- K964435 — PRIMARY IV SET
- K964654 — BECTON DICKINSON BLUNT PLASTIC CANNULA
- K964989 — CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
- K970029 — KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
- K970031 — FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
- K970113 — ULTRA-BLEND PLUS
- K970116 — ESG-1 ELECTROSONOGRAM (ESG-1)
- K970121 — STONE DISLODGER, BASKET
- K970217 — VISTA ILLUMINATION SYSTEM
- K970271 — ALEXANDER MANUFACTURING COMPANY
- K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
- K970312 — CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
- K970438 — INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
- K970637 — ACCUCURE 1000
- K970701 — DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
- K970733 — SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
- K970800 — MAXCESS NEEDLEFREE - Y- SITE (100713)
- K970830 — REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
Data sourced from openFDA. This site is unofficial and independent of the FDA.