FDA 510(k) clearances — page 924
clearances on record, most recent first.
Clearances — page 924
92,301–92,400 of 175,890- 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)
- K971134 — VISTA EYESHOWER
- K971857 — MUMPS IGG ELISA TESTY
- K972518 — TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
- K972655 — CONTROL SYRINGE
- K972696 — IL TEST D-DIMER
- K972903 — IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
- K972961 — STELKAST BIPOLAR SYSTEM
- K973082 — VENTRAL WALL DEFECT REDUCTION SILO
- K973218 — NIDEK HANDY
- K973220 — RODENSTOCK LASER SLITLAMP
- K973226 — TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
- K973306 — IL TEST APTT-SP
- K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS
- K973533 — NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
- K973665 — MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
- K973879 — OSOM CARD HCG-URINE TEST
- K973885 — OTICON DIGISOUND ITE
- K973886 — OTICON DIGISOUND COMPACT
- K973933 — SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
- K973972 — PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
- K973973 — ELECSYS CALLCHECK DIGOXIN
- K974000 — Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
- K955808 — DYNA T-2000 PHYSICAL THERAPY SYSTEM
- K964926 — BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
- K971719 — THEROX INFUSION GUIDEWIRES
- K971730 — DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
- K971912 — PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES
- K972537 — ERCO-VAC
- K972893 — PARTNERSHIP REVISION FEMORAL STEMS
- K972928 — KERBOULL CROSS
- K972944 — MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
- K972994 — EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
- K973023 — INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
- K973031 — STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
- K973060 — DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM
- K973124 — APR POROUS HA HIP SYSTEM
- K973281 — THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
- K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
- K973565 — QUICK-CARE BIOPSY NEEDLE
- K973627 — STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
- K963368 — GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE
- K963967 — GLYCAR PERICARDIAL PATCH
- K964098 — CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K964210 — RETRIEVER II
- K965141 — TRUQUANT BR RIA
- K970482 — TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
- K970756 — MERCURY MEDICAL REUSABLE CPR BAG
Data sourced from openFDA. This site is unofficial and independent of the FDA.