FDA 510(k) clearances — page 931
clearances on record, most recent first.
Clearances — page 931
93,001–93,100 of 176,637- K974001 — ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
- K962282 — TUTTNAUER PREVACUUM TABLE AUTOCLAVE
- K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
- K970801 — BCI MODEL 6004 NIBP MONITOR (6004)
- K970907 — CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)
- K971030 — MIE FALCON, DATEX ENGSTROM FLEXIMA II
- K971803 — NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
- K971993 — ODI COMPRESSION HIP SCREW SYSTEM
- K972596 — DEPUY DURALOC ACETABULAR CUP SYSTEM
- K973036 — 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
- K973038 — ADJUSTABLE THERASNORE
- K973056 — BONE GRAFT SCREW SYSTEM
- K973057 — 1.4 FR MAPCATH SENSOR STYLET
- K973131 — SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
- K973141 — HEART ACCESS PLUS CARDIAC EVENT RECORDER
- K973560 — BONE GRAFT HARVESTER
- K973581 — ACE VALPROIC ACID REAGENT, AED CALIBRATORS
- K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS
- K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
- K973674 — ELECSYS FOLATE
- K973850 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
- K964407 — IMX CA 15-3
- K965228 — FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
- K970302 — APO-TEK LP(A)
- K972660 — RAVEN DRY PRINTER
- K972995 — THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
- K972997 — AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
- K973005 — THE CORIFIX LIGAMENT ANCHOR
- K973009 — MITEK NON ABSORBABLE POLYPROPYLENE H FIX
- K973010 — REALTIME 3D DIAGNOSTIC WORKSTATION
- K973018 — SYNTHES MINI LENGTHENING APPARATUS
- K973024 — INTELECT LEGEND ULTRASOUND
- K973113 — MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
- K973400 — MAMMOTEST ADAPTER DRIVER
- K973476 — KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
- K973482 — PHILIPS INTEGRIS V5000 AND BV5000
- K973493 — PLANMED CYTOGUIDE
- K973598 — SIREMOBIL CO2
- K973915 — INFLATABLE POSITIONING CUSHIONS
- K974075 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K962554 — FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
- K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
- K971507 — O2 BOOT
- K971757 — LOW PROFILE FEEDING SET ACCESSORY
- K971836 — VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
- K971990 — GESCO PER-Q-CATH PICC CATHETERS
- K971991 — GESCO PER-Q-CATH MIDLINE CATHETERS
- K972121 — ACUITY CENTRAL STATION
- K972965 — STERI-OSS UNTIL IMPLANT CEMENT
- K973050 — MICRO21 WITH WBC ESTIMATE
- K973058 — PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
- K973059 — PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
- K973068 — KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
- K973301 — ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
- K973346 — UNCOATED ELECTROSURGICAL ELECTRODE
- K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
- K973546 — KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
- K973575 — DURALASTIC ANATOMICAL CHIN IMPLANTS
- K973586 — SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
- K973757 — D.O.R.C. SOLUX LIGHT SOURCE
- K962359 — LIFEPAK 300
- K962473 — (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH
- K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
- K971928 — QUEST VESSEL CATHETER
- K972203 — BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT
- K972624 — POLY (VINYL) EXAM GLOVE, POWDER-FREE
- K972927 — ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR
- K972962 — 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K973007 — DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
- K973070 — CONVEEN EASICATH SET
- K973134 — OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
- K973200 — CARIES STAIN
- K973215 — STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
- K973536 — ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
- K973551 — MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
- K973578 — INVOTEC EAR TAMPON (WICK) W/STRING
- K973667 — VITAPEX PRE-LOADED DENTAL SYRINGE
- K973726 — FINGERPRINT DRUG SCREENING DEVICE
- K973974 — DADE TRU-LIQUID CARDIAC CONTROL
- K970857 — ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
- K971295 — AVE BRIDGE STENT SYSTEM
- K971838 — MICRO ELECTRODES
- K972057 — POWERTREK INSTRUMENTS
- K972090 — POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
- K972295 — SERAQUEST VZV IGG
- K972464 — VITALMIX PLUS EMPTY I.V. CONTAINER
- K973012 — MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM
- K973079 — L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
- K973081 — DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)
- K973158 — ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE
- K973695 — PASCO MIC AND MIC/ID PANELS
- K953893 — PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
- K963957 — TRINITY DVT SYSTEM
- K964020 — AXSYM CA 125
- K964185 — IMX CA 125
- K964397 — THERAPIK
- K970352 — SMARTVAC SMOKE EVACUATION SYSTEM
- K970488 — HYDROCHECK MICRO FILTER
- K970853 — PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
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