FDA 510(k) clearances — page 973
clearances on record, most recent first.
Clearances — page 973
97,201–97,300 of 175,890- K961312 — HEMOCUE B-HEMOGLOBIN SYSTEM
- K961544 — QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
- K961545 — QUALITROL RF CONTROLS
- K961550 — QUALITROL MONO CONTROL SERUM SET
- K962542 — AIR MOTOR HANDPIECE TN-102
- K963359 — INSUFFLATION NEEDLE
- K953823 — ARTERIAL VENOUS BLOOD TUBING SET
- K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSING
- K961356 — MAMMARY SIZER
- K961522 — KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
- K961826 — DIGIPAN
- K962043 — AUTO SUTURE MODIFIED VCS CLIP APPLIER
- K962462 — MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
- K962592 — OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS
- K962646 — PRIME MODULAR ENDO HEAD
- K962888 — AFFIRM ONE-STEP HOME PREGNANCY TEST
- K963039 — SURESKIN STANDARD, BORDER, AND THIN
- K963175 — GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
- K963244 — ACETAMINOPHEN FLEX REAGENT CARTRIDGE
- K963246 — TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
- K963300 — DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)
- K963383 — HICHEM ALP/AMP REAGENT KIT
- K953943 — AXSYM CMV IGG ANTIBODY ASSAY
- K955547 — CHIPS STANDUP WHEELCHAIR
- K955548 — CHIPS POWERED WHEELCHAIR
- K955577 — ECLIPSE VERSION 3.0
- K960024 — STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
- K960078 — ASTHMA MONITOR
- K960087 — SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
- K960865 — STEP OPTION TO PRISM 2000
- K961140 — FLUOROPLUS CARDIAC TV
- K961580 — PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS
- K962236 — SCARF THREAD-HEAD SCREW
- K962427 — COBE CENTRYSYSTEM 700 HG HEMODIALYZER
- K962465 — TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS
- K962494 — PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE
- K962503 — GUGLIELMI DETACHABLE COIL
- K962544 — MICRO DIAMOND-POINT DISSECTION NEEDLES
- K962589 — AURORA DIAGNOSTIC WORKSTATION
- K962590 — SIGNALDRESS
- K962677 — ESTEEM 1.5T MRI SYSTEM
- K962806 — OHMEDA-OHIO CAE PLUS INCUBATOR
- K962896 — KODAK DIGITAL SCIENCE REMOTE CASSETTE
- K962986 — MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
- K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM
- K963043 — ENDOSPOT
- K963044 — ENDOBEAM
- K963252 — TBAN
- K963607 — HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL
- K960674 — CONTRAST INJECTION LINES
- K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
- K962216 — TSH (MICROWELL) ELISA
- K962402 — AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
- K962448 — PRIMALOC CEMENTED HIP SYSTEM
- K962525 — ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM
- K962560 — VITALITY HIP STEM
- K962692 — ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE
- K963197 — ON.SITE ALCOHOL
- K953663 — CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
- K960061 — STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
- K960754 — SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
- K960759 — GONOPOX TEST KIT
- K961046 — 10B ARGININE BROTH
- K961049 — FLEX NEEDLE
- K961536 — FLEXSCOPE
- K962151 — RYDER LACRIMAL INTUBATIONSET
- K962429 — SAFETY VEST
- K962441 — PROSPORE(STEARO FOR STEAM STERILIZER)
- K962843 — MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
- K963157 — ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY)
- K952220 — MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
- K952660 — BRAUN HEMODIALYSIS CATHETER
- K960647 — OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS
- K960851 — THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
- K960942 — LATEX PATIENT EXAMINATION GLOVE
- K960984 — SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
- K961186 — DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
- K961239 — DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
- K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
- K961526 — PRESS-FIT POROUS SHELL
- K961572 — VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
- K961745 — BRAUN PERCUTANEOUS INTRODUCER SET
- K961920 — CROSS PIN
- K962307 — RHYDER DIAGNOSTIC CATHETER
- K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
- K962467 — RV PACING LEAD
- K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS
- K953238 — DRAGER MICRO VENT
- K954426 — CPR LIFE MASK COMPACT BARRIER
- K954427 — HELPING HAND
- K960503 — DANTEC DUET
- K961048 — OLYMPUS MH-246R BALLOON SHEATH
- K961928 — BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
- K961941 — LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
- K962293 — ENDOSONICS AUTOMATIC PULL BACK DEVICE
- K962388 — IN THE EAR HEARING AID
- K962460 — EG-3800T, VIDEO GASTROSCOPE
- K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
- K962817 — DRUG CALIBRATOR II
- K962826 — MEDLINE RADIOLOGY-DIAGNOSTIC KITS
Data sourced from openFDA. This site is unofficial and independent of the FDA.