FDA 510(k) clearances — page 1315
clearances on record, most recent first.
Clearances — page 1315
131,401–131,500 of 176,637- K893835 — DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
- K893895 — HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
- K893959 — P.S.A. FEMORAL HIP PROSTHESIS
- K893966 — HDL PRECIPITATING REAGENT
- K893970 — ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
- K893971 — ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
- K893986 — NEW WEST SUNGLASSES
- K894012 — MINICLINIC PREGNANCY TEST
- K894045 — MODIFIED POLYCHROME IV STAIN
- K894112 — RAOMER
- K894136 — WORLD CHAIR
- K894203 — ANTI-THYROGLOBULIN TEST KIT
- K894205 — TECNOL SILK STRIP
- K894303 — MEDSCOPE 4MM ARTHROSCOPE
- K894338 — ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
- K894364 — MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
- K885243 — NEOVO2R VENTILATORY
- K890093 — PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET
- K891572 — ANGIOGRAPHY CUSTOM PACKS
- K891820 — DISPOSABLE MEDICAL GOWNS
- K892355 — M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ
- K892406 — MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
- K892407 — MODIFIED DEMAND NASAL OXYGEN CANNULA
- K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
- K892440 — KENDALL CURITY EXTENSION TUBES
- K892575 — VINYL PATIENT EXAMINATION GLOVES
- K893209 — ENTERA-FLO SPIKE SET
- K893295 — LATEX EXAMINATION GLOVES
- K893296 — LATEX EXAMINATION GLOVES
- K893612 — TWO TANK DISSOLUTION MODULE
- K893677 — HOLLOW FIBER DIALYZER FOCUS 70H
- K893679 — SHUNT CONNECTORS
- K893712 — PERITONEAL DIALYSIS SYSTEM AND ACCESS.
- K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER
- K893828 — ML-800 AUTOELECTRONIC LIGHT SOURCE
- K893864 — LATEX EXAMINATION GLOVES
- K894326 — THORACENTISIS KIT
- K881133 — 70-X/RVG (RADIOVISIOGRAPHY)
- K890194 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE
- K891050 — STAT CHEM SYSTEM
- K891762 — MINICLINIC OVULATION PREDICTION TEST
- K892379 — THE POUCH GROIN & ABDOMINAL STRESS AID
- K892393 — ACID PHOSPHATASE REAGENT
- K892410 — FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
- K892500 — CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
- K892668 — TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
- K892845 — SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE
- K892848 — PANCREATIC A-AMYLASE PNP
- K892867 — ULCERCARE
- K892875 — BIAD NUCLEAR IMAGING SYSTEM
- K892929 — TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES
- K892934 — 1 VIDEO TAPE RECORDER MODEL BK-224 H
- K893007 — REP(TM) CK-2 STAT KIT, CAT. NO. 3074
- K893139 — DOCUMENT(TM) URIC ACID LINEARITY TEST SET
- K893269 — BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
- K893409 — YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
- K893560 — ALT REAGENT (PROCEDURE NUMBER 159)
- K893580 — DADE LIPID-TROL
- K893585 — 14 COLOR VIDEO DISPLAY 211-260-010
- K893637 — MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM
- K893641 — COBAS FARA CENTRIFUGAL ANALYZER
- K893662 — J&S IRON SATURATING REAGENTS
- K893673 — RMS 180
- K893674 — RME 325R
- K893681 — MAMM-AIRE CP
- K893689 — VISION INTEGRATED PERFORMANCE OPTION
- K893690 — SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)
- K893733 — CENTRICON CONCENTRATOR
- K893752 — ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
- K893765 — GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
- K894053 — 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
- K890132 — POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
- K890963 — SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4
- K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
- K892366 — POROUS GENESIS STEMMED TIBIAL COMPONENT
- K892394 — P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS
- K892944 — INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515
- K893042 — CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM
- K892389 — BIOPSY KIT
- K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
- K883871 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
- K883896 — NEUROTRAIN
- K884495 — SURGICAL GLOVES
- K884505 — BASAL/BOLUS INFUSORS
- K885058 — CARDIOCAP(TM) DR-104 REPORTER
- K885175 — MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
- K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
- K890124 — ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
- K890676 — DISPOSABLE TRANSDUCER MANIFOLD
- K890713 — OVERDENTURE - STUD ATTACHMENT
- K890746 — MYOTEST DBS NERVE STIMULATOR
- K890858 — PATIENT EXAMINATION GLOVES
- K890891 — LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL)
- K890974 — PATIENT EXAMINATION GLOVE
- K891010 — NR LATEX EXAMINATION GLOVES
- K891102 — SHIELD BRAND (PATIENT EXAMINATION GLOVE)
- K891110 — LATEX PATIENT EXAMINATION GLOVES
- K891123 — RUBBERCARE PATIENT EXAMINATION GLOVE
- K891134 — PATIENT EXAMINATION GLOVE (LATEX)
- K891174 — PATIENT EXAMINATION GLOVES (LATEX)
Data sourced from openFDA. This site is unofficial and independent of the FDA.