FDA 510(k) clearances — page 1298
clearances on record, most recent first.
Clearances — page 1298
129,701–129,800 of 176,637- K895455 — SELDINGER PERCUTANEOUS 2 PC NEEDLES
- K895583 — ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
- K895664 — TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
- K895753 — BREVET DISPOSABLE CONNECTORS
- K895778 — QUANTIMETRIX BILIRUBIN CALIBRATORS
- K895822 — TOTAL BILIRUBIN L.F.
- K896028 — GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
- K894328 — TDX(R) LITES(TM) LITHIUM
- K894954 — .22 & 1.2 MICRON IV FILTERS
- K895123 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
- K895251 — BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
- K895390 — CARDS O.S. (TM) HCG-URINE
- K895394 — MOBILE X-RAY TELEVISION UNIT WHA-10A/B
- K895546 — MODIFIED SPANTRON FRAME FREEZE
- K895560 — MODIFIED HOMECLINIC PREGNANCY TEST
- K895585 — HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
- K895796 — API UNISCEPT KB
- K895914 — ABBOTT IMX IGE
- K895969 — RADKOR DXG-650R
- K896001 — ALANINE AMINOTRANSFERASE (ALT)
- K896321 — NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
- K891004 — RAPIDEC STAPH
- K895081 — PROMONTORY STIMULATING ELECTRODE
- K896044 — CROSS CANCELLOUS BONE SCREW
- K896052 — FIBRINOGEN ASSAY KIT
- K896092 — ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
- K896154 — PARA TECH FOR TECHNICON H-1
- K892443 — BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
- K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS
- K893350 — LATEX EXAMINATION GLOVES
- K893661 — QUANTAI UG REAGENT STRIP
- K894106 — DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST
- K894715 — CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
- K894968 — ULTRACOMPACT
- K894990 — DAVOL ARTHROSCOPY CANNULA
- K895043 — COMA COCAINE METABOLITE ASSAY (EIA)
- K895175 — NF-1 MINDPEACE
- K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-402
- K895220 — THE ON-GARD RECAPPER
- K895279 — LASERMATIC COMBOLASER MODEL 5050
- K895281 — TRANSDUCER PROTECTOR
- K895381 — HDL SINGLES
- K895552 — LATEX EXAMINATION GLOVES
- K895600 — HUMAN (IGG) SUBCLASS (EIA) KIT
- K895686 — DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)
- K895737 — THE DOCTOR'S CHOICE ELECTRODE
- K895759 — HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
- K895766 — ASNIS II GUIDED BONE SCREW
- K895804 — SHANNON LATEX MEDICAL GLOVES
- K895911 — ONE TOUCH II METER
- K895984 — WAKO(TM) AUTOKIT GAMMA-GT
- K896021 — CEDIA DIGITOXIN ASSAY
- K896085 — SURGI-BRUSH
- K896256 — REFLUX BED
- K896271 — QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
- K896272 — QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
- K896327 — SURGEON'S GLOVES
- K891182 — PATIENT EXAMINATION GLOVES
- K892076 — PATIENT EXAMINATION GLOVES (LATEX)
- K892571 — PATIENT EXAMINATION GLOVES (LATEX)
- K893075 — PATIENT EXAMINATION GLOVES
- K893804 — LATEX EXAMINATION GLOVES
- K894194 — LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP)
- K894387 — WESTCO MADAYAG PAB NEEDLE
- K894967 — LATEX PATIENT EXAMINATION GLOVES
- K895130 — HEIMLICH MICRO TRACH
- K895171 — BLOOD GAS SAFETY SYRINGE
- K895354 — INTRASITE CAVITY WOUND DRESSING
- K884651 — ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
- K890044 — BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
- K892941 — CCO SYSTEM MODEL SP1467,SP5567,SP6267
- K893744 — SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
- K893821 — ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.
- K893851 — THERASTIM
- K894036 — TOITU FETAL ACTOCARDIOGRAPH, MT-332
- K894142 — ULTRANET-S COLLIMATOR
- K894514 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
- K895026 — HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
- K895045 — MODEL 410T TELECOMMUNICATION SYSTEM
- K895268 — ARROW HANDS-OFF THERMO-PACE
- K895295 — ULTIMA XS MICROCURRENT TENS
- K895466 — AVL MODEL 912 CO-OXYLITE
- K895500 — PATIENT POSITIONING ACCESSORIES
- K895561 — PEMACO 3000 INTRAORAL DENTAL WAX
- K895562 — PEMACO 2000 INTRAORAL DENTAL WAX
- K895563 — PEMACO BITE WAX SHEETS
- K895564 — PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD
- K895566 — PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT
- K895671 — STIMTRAC II CATALOG NUMBER 78-8500
- K895725 — BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES
- K895730 — X-RAY EQUIPMENT (VARIOUS TYPES)
- K895996 — RHEUMELISA ASSAY FOR SM AUTOANTIBODIES
- K895997 — RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
- K896059 — MODIFIED QM300 ALBUMIN ANTIBODY PACK
- K890665 — MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES
- K890902 — BIOFIX* BIODEGRADABLE FIXATION ROD
- K891256 — PATIENT EXAMINATION GLOVES (LATEX)
- K892167 — PATIENT EXAMINATION GLOVES (LATEX)
- K892561 — PATIENT EXAMINATION GLOVES (LATEX)
- K893770 — TERM GUARD II DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.