FDA 510(k) clearances — page 1290
clearances on record, most recent first.
Clearances — page 1290
128,901–129,000 of 175,890- K894402 — HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL
- K894604 — BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
- K894965 — POROUS-COATED TITANIUM ACETABULAR CUP
- K895164 — EAGLE DS
- K895242 — PAPPAS TRI-FLANGE VENTILATION TUBE
- K895245 — FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
- K895467 — ORTHOPHOS AND ORTHOPHOS C
- K895557 — PATIENT EXAMINATION GLOVES
- K895607 — POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
- K895716 — LATEX PATIENT EXAMINATION GLOVES
- K895794 — GE MR MAX SYSTEM
- K895871 — LIFEPORT POLYURETHANE CATHETER
- K896036 — THE COMFORTABLE CANNULA
- K896074 — VISION PHENYTOIN
- K896088 — FEMORAL ANGIOGRAPHY DRAPE
- K896116 — ENTRAPPING FILTER
- K896222 — FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
- K881334 — LIGHT COAGULATOR LC 250
- K892359 — MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM
- K893377 — RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
- K893380 — QCR SYSTEM I AND QCR SYSTEM II
- K893499 — CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS
- K894497 — LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.)
- K895023 — LATEX PATIENT EXAMINATION GLOVE
- K895194 — LATEX PATIENT EXAMINATION GLOVES
- K895227 — SKINTEX LATEX EXAMINATION GLOVES
- K895239 — MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER
- K895247 — MODEL IR103 SURGICAL LASER SYSTEM
- K895340 — ABTEX OR JUTAMAL LATEX EXAMINATION GLOVES
- K895459 — LATEX PATIENT EXAMINATION GLOVES
- K895499 — POLY-FLEX LATEX EXAMINATION GLOVES
- K896434 — AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
- K894056 — POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
- K894088 — TECA NEUROMAPPER 1620, BRAIN MAPPER
- K894367 — LEUKOSPORT(TM) ADHESIVE TAPE
- K894714 — 1989 SOFTWARE REVISION TO THE BMT-1100
- K894928 — STERILE LATEX SURGEON'S GLOVES
- K895034 — BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C
- K895204 — EPI-CATH(TM) EPIDURAL CATHETER
- K895233 — BACTERIAL AND VIRAL FILTER
- K895360 — C.P.A.P. VALVE AND C.P.P.A. KIT
- K895545 — V*S*R(TM) SCOPE
- K895668 — DIGICAM LHP (VIDEO INTERFACE OPTION)
- K895841 — MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE.
- K891338 — SMYLON (DENTAL STAIN ERASER)
- K893041 — NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
- K893829 — POWERED EYE WASH
- K893926 — SONOCA ULTRASONIC SURGICAL SYSTEM
- K894471 — SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY
- K894711 — ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
- K894712 — ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
- K895214 — HEMOSTASIS VALVE
- K895454 — SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.