FDA 510(k) clearances — page 918
clearances on record, most recent first.
Clearances — page 918
91,701–91,800 of 175,890- K971663 — WELLCOLEX E.COLI O157:H7
- K971696 — SENTINEL RECORDER, MODELS 471/472
- K973787 — MEDRAD 1.5T EXTREMITY ARRAY
- K973833 — CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL
- K971570 — EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
- K971775 — INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
- K972258 — HI-CARE CLOSED SUCTION SYSTEM
- K973736 — AESCULAP HILAN MOTOR SYSTEM
- K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289)
- K973774 — CODMAN HAKIM MICRO PRECISION VALVE
- K973806 — DUODERM HYDROACTIVE GEL
- K973857 — FLOSTAT VASCULAR REPORT GENERATOR (VRG)
- K973862 — PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
- K973873 — DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
- K971339 — INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
- K973683 — OMEGA 21 SYSTEM
- K973706 — DURA-GUARD-DURAL REPAIR PATCH
- K973714 — VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
- K973729 — POWERFLEX PEC IMPLANT
- K973730 — DURASIL I AND DURASIL II
- K973761 — MICRO-STRIP FOR OPIATE METABOLITES
- K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
- K974159 — OSOM HCG-URINE TEST MODEL 101
- K974191 — EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
- K974262 — SYSCOS IDC - G, IDC, BSC, IDC - G
- K974425 — BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
- K963817 — LEVO MOBIL LCM
- K963969 — INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB
- K971637 — COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K972480 — 3I BIORESORBABLE FIXATION TACK
- K973631 — LORAD M-III ELITE (M-III E)
- K973638 — N.I.T., INC. NEEDLE GUIDING TEMPLATE
- K973644 — FLOSTAT VASCULAR LAB
- K973688 — DUODERM CONTROL GEL FORMULA BORDER DRESSING
- K973689 — DUODERM HYDROACTIVE DRESSING
- K973719 — MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER
- K973767 — HARMONIC IMAGING WITH CONTRAST
- K973807 — DUODERM HYDROACTIVE PASTE
- K973951 — LEVO COMPACT-EASY LCE
- K974048 — INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
- K974054 — DISTAL CENTRALIZER, EXETER II HIP SYSTEM
- K974306 — SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
- K970419 — DAXOR MAX100 SYRINGE (MAX100)
- K970901 — GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
- K971360 — SYNTEX
- K971582 — NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET
- K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
- K972555 — CATHETER TUNNELER
- K972914 — SYVEK PATCH
- K973513 — SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
- K973632 — DUODERM CGF CONTROL GEL FORMULA DRESSING
- K973686 — ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
- K973908 — AUKLET CT SCANNER, TSX-003A
- K973954 — IMAGEN RESPIRATORY SCREEN
- K973959 — OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
- K973988 — RDI HOMOGENEOUS HDL CHOLESTEROL TEST
- K974032 — ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
- K974036 — PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
- K974068 — PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
- K974198 — TAKY-SPIKE PLUS
- K974240 — LIGHTLINE-M
- K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
- K974515 — ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
- K974516 — ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
- K974551 — SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
- K962985 — KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
- K963013 — PREFERENCE 60 AND PREFERENCE 60 TORIC
- K964271 — IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID
- K970708 — CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
- K971086 — RADIAL AND FEMORAL ARTERY CATHETER
- K972314 — PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
- K972699 — AESOP 3000 SYSTEM AND ACCESSORIES
- K972915 — ERBIUM 2000 LASER FAMILY
- K972946 — AURELUX 77
- K973291 — DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
- K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
- K973595 — THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM
- K973603 — SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM
- K973610 — SKYVAL
- K973618 — SOMNOPLASTY SYSTEM
- K973675 — NATURAL-HIP POROUS STEM WITH OFFSET
- K973681 — NATURAL-HIP COCR OFFSET STEM
- K973685 — REVELATION POROUS HIP STEM
- K973708 — TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
- K973727 — ELECTRODE, ELECTROCARDIOGRAPH
- K973825 — MIDSTREAM HOME REGNANCY TEST
- K973853 — KOLPLAST VAGINAL SPECULUM
- K973876 — PROPHYFLEX 2, MODEL 2012
- K973893 — AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
- K973944 — ORTHOFIX FEMORAL NAILING SYTEM
- K974016 — CERCLAGE CABLE WITH HEX BUTTON
- K974020 — SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM
- K974021 — SIGNAL PREGNANCY TEST KIT
- K974042 — AMSURE CLEANSING ENEMA SET
- K974052 — QUICKVUE SEMI-Q HCG-COMBO
- K974127 — HYDRA METER
- K974154 — CHOICE ACCU-TEST PREGNANCY TEST KIT
- K974171 — COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
- K974290 — MICROPROTEIN STANDARD KIT
- K974300 — TELEMED SYSTEMS RETRIEVAL BASKET
Data sourced from openFDA. This site is unofficial and independent of the FDA.