FDA 510(k) clearances — page 989
clearances on record, most recent first.
Clearances — page 989
98,801–98,900 of 176,637- K960669 — HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
- K960803 — RX TEXTILES STERILE STOCKINETTE
- K961402 — STS SHIELD WITH MASK
- K961619 — DEPUY ENDURANCE CALCAR HIP PROSTHESIS
- K962355 — FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K962512 — BOSTON CONTACT LENS CASE
- K954163 — RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
- K954772 — QUICKELS QS 200 SYSTEM
- K954773 — QUICKELS QS 100 SYSTEM
- K955045 — OMNI-TRAK PATIENT MONITORING SYSTEM
- K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
- K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT
- K961562 — OSTEOMARK
- K961726 — ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
- K961758 — CARASYN HYDROGEL WOUND PRODUCTS
- K962056 — ADVANCED MICRO-OSMOMETER MODEL 3300
- K962373 — N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
- K962421 — SORBCEL ALGINATE/CMC WOUND DRESSING
- K954065 — BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
- K954290 — WALLSTENT ENTERAL ENDOPROTHESIS
- K955088 — NEOSONO 2000
- K955799 — COPALIS CMV TOTAL ANTIBODY ASSAY
- K955821 — I.V. ADMINISTRATION SETS
- K960769 — ACUPUNCTURE NEEDLE PACK
- K961133 — SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE
- K961243 — OCUSYSTEM ART ADVANTAGE
- K961296 — WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
- K961340 — NOVA LITE ANCA
- K961362 — AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
- K961424 — INTRAN 500
- K961507 — WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
- K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS
- K961578 — SUTURE ANCHOR
- K961579 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
- K961585 — SURGICAL DYNAMICS POP RIVET
- K961685 — P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
- K961728 — MIRUSCONE ABUTMENT SYSTEM
- K961737 — CERA ONE ABUTMENT SYSTEM
- K961754 — SAFETY RELEASE MODULE
- K961818 — GENTAMICIN DISK (120MCG)
- K961819 — STREPTOMYCIN DISK (300MCG)
- K961913 — QUANTA LITE ENA 6 ELISA
- K961940 — INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
- K962183 — BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
- K962523 — N LATEX CRP MONO REAGENT
- K955597 — MEDI-TRACE DEFIB PADS
- K955612 — RD-1200H NORMAL MODE RUBY LASER SYSTEM
- K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
- K961391 — FLEXART QD HEAD/NECK COIL
- K961445 — RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
- K961483 — DURACON ALL POLYETHYLENE PATELLA II
- K961564 — EG-2940, VIDEO GASTROSCOPE
- K961568 — ED-344OT
- K961589 — APR FULLY TEXTURED HIP STEM
- K961934 — PURITAN FOAM TIP SWAB MODEL 2197
- K962024 — S-57 VIDEO IMAGING SYSTEM
- K962147 — DEXTERITY PNEUMO SLEEVE SET
- K955608 — MCCOY CELL CULTURES
- K955743 — SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
- K955772 — CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
- K960392 — CDM
- K960882 — CONTROL SYRINGE
- K961319 — EPIVIEW
- K961373 — ACETAMINOPHEN SERUM TOX EIA ASSAY
- K961434 — VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM
- K961448 — FUJI IX GP
- K961678 — HUMAN GROWTH HORMONE IMMUNOASSAY KIT
- K961703 — COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
- K962211 — UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
- K951965 — DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
- K955845 — LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
- K960497 — FLEXIBLE PHASED ARRAY SPINE COIL
- K960888 — CHEK-STIX U.T.I. SELF-TEST
- K961011 — DTX-200 BONE DENSITOMETER
- K961274 — OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
- K961482 — DURACON INSET PATELLA WITH CENTRAL PEG
- K961517 — ETEST SUBMISSION FOR CEFOTETAN
- K961519 — ETEST SUBMISSION FOR AZITHROMYCIN
- K961557 — ALLIANCE 2690 SEPARATIONS MODULE
- K961648 — THE WAND
- K961803 — SPUNCRIT (MODEL DRC-40)
- K962032 — KARL STORZ TWIN TRANSILLUMINATOR
- K962395 — SPECIMEN RETRIEVAL BAG
- K962432 — LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
- K941460 — FRESENIUS BLOOD TEMPERATURE MONITOR
- K954737 — SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
- K960265 — ADVANTAGE WINDOWS WITH FUNCTOOL OPTION
- K960391 — STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
- K961294 — SCIMED DISPATCH GOLD CORONARY CATHETER
- K961339 — CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES
- K961366 — MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
- K961377 — MANAN PROSTATE LOCKING INTRODUCER SET
- K961403 — LIFE IMAGING SYSTEMS LIS 6000 A
- K961451 — DICOMNET
- K961464 — SELECT/SP
- K961506 — MICROSPAN HYSTEROSCOPE SHEATH
- K961632 — MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
- K961637 — PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)
- K961680 — SONY DKR-700 DIGITAL STILL RECORDER
- K961827 — IN-THE-EAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.