FDA 510(k) clearances — page 956
clearances on record, most recent first.
Clearances — page 956
95,501–95,600 of 176,637- K970164 — ROLL AID
- K970289 — COMPRESSOR/NEBULIZER #3650
- K970533 — MODEL 1100 COLD THERAPY DEVICE
- K970602 — VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
- K970755 — STEALTHSHIELD
- K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE
- K971192 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
- K962814 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K963063 — SNORE TEC
- K963501 — HERRICK ULTIMATE PUNCTUM PLUG
- K963708 — HERRICK ULTIMATE PUNCTUM PLUG
- K964849 — ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM
- K964900 — RAPID DRUG SCREEN
- K964918 — NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
- K970133 — AMERIGEL OINTMENT
- K970194 — PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
- K970203 — EPIX VT
- K970214 — 3 DIMENSIONAL VIDEO ENDOSCOPE
- K970255 — KIPP MED I.V. MANIFOLD
- K970330 — DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
- K970369 — VISTA MINI CAMERA SYSTEM
- K970483 — AQUALITE INTACT PTH
- K970894 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
- K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN
- K971133 — URIC, UA, OR URIC ACID
- K971211 — DISPENS-O-DISC SPARFLOXACIN
- K955653 — VENISECT LASER LANCET
- K961924 — IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
- K963030 — LEIBINGER IMF SCREW
- K964253 — DERMA 20 LASER SYSTEM
- K964261 — SMF STAINLESS STEEL BONE SCREWS
- K964867 — HYBRID RESIN COMPOSITE
- K970123 — DENTSPLY CAVITRON SPS SCALER SYSTEM
- K970128 — ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
- K970184 — OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
- K970272 — PATIENT RESTRAINT
- K970273 — PATIENT RESTRAINTS
- K970274 — PATIENT RESTRAINTS
- K970275 — PATIENT RESTRAINTS
- K970278 — MICROVASIVE GOLD PROBE
- K970453 — B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
- K970563 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE
- K970911 — LEE PLATE
- K962937 — CARDIO TEAM II
- K964446 — MYELOPEROXIDASE ELISA TEST SYSTEM
- K964448 — PROTEINASE-3 IGG ELISA TEST SYSTEM
- K964449 — ANCA SCREEN ELISA TEST SYSTEM
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.