FDA 510(k) clearances — page 1244
clearances on record, most recent first.
Clearances — page 1244
124,301–124,400 of 176,637- K903917 — COMPACT MONITOR SMK 210,211,230,231,240
- K904222 — VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
- K904247 — FREE PROTEIN S REAGENT CAT. NO. 5363
- K904255 — FOCUS T41,T41F,T43, T43F,T44F
- K904589 — KODAK SURECELL(TM) STREP A CONTROL FLUID SET
- K904779 — BUTTON REPLACEMENT GASTROSTOMY DEVICE
- K904828 — OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
- K905031 — PATIENT EXAMINATION GLOVES
- K905042 — COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
- K905055 — PM GLOVE
- K905229 — LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
- K905501 — ELITE 5000
- K905637 — ILLUMINA MODEL 780 CO2 LASER SYSTEM
- K905678 — ALADERM
- K905685 — ZENITH COX FLEXION CHIROPRACTIC TABLE
- K905735 — GENNY DENNY IV SHIELD
- K910026 — ATI MEDICAL COMFORT PLUS CPM PAD
- K910149 — ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT
- K910151 — ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT
- K903675 — MAGNETIC RESONANCE THERAPY DEVICE
- K904326 — DE-TOX TUBES A AND DE-TOX TUBES B
- K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
- K904816 — THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
- K905247 — SHBG IRMA KIT
- K905328 — WILL-CERAM BRUSHES, SUPER BRUSH KIT
- K905379 — AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
- K905588 — CREATINE KINASE UV REAGENT SET
- K905601 — ECLIPSE ICA TRIGLYCERIDES
- K905689 — CEDIA PHENYTOIN ASSAY
- K905719 — ECLIPSE ICA DIGOXIN
- K910086 — ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
- K902674 — DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
- K902910 — CYTOASPIRATOR
- K903700 — IPG-II MODULE
- K903711 — RHEOLOGIC I
- K903814 — NEUROMED TS8 TEST STIMULATOR
- K903823 — SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
- K904282 — BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
- K904287 — STEALTH DILATION CATHETER SYSTEM/MODIFICATION
- K904378 — F.T.I. MEDICAL LIGHT GUIDE
- K904801 — ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
- K904888 — AUTOWAND(TM) 7XXX SERIES, MODIFICATION
- K904954 — CONDOR DIGITAL INFLATION SYRINGE
- K904965 — SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
- K905018 — LAB-SITE SAFETY NEEDLE
- K905322 — MIDIGOLD 50
- K905393 — HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR
- K905587 — AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE
- K905602 — ECLIPSE ICA BUN
- K900099 — THE O-RING SYSTEM - ORS
- K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
- K903697 — HAWAIIAN SUPRACONDYLAR PLATE
- K903733 — ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
- K904777 — SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
- K904979 — AVI MODEL 600 SYRINGE PUMP, MODIFICATION
- K904994 — CLOSED SYSTEM FLUSH SET
- K905017 — LAB-SITE
- K905100 — HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
- K905311 — DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.
- K905312 — DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS
- K905319 — VARIOUS
- K905387 — DEGUDENT GS
- K905513 — GLYC-AFFIN(TM)-GA
- K905532 — CIBA CORNING ACS T4 IMMUNOASSAY
- K905551 — PATIENT EXAMINATION GLOVES
- K905600 — TECHLYTE ELECTROLYTE ANALYZER
- K905659 — SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
- K905665 — PATIENT EXAMINATION GLOVES
- K905700 — EZ-SCREEN: AMPHETAMINES
- K905730 — ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
- K910045 — PATIENT EXAMINATION GLOVES-POWDER FREED
- K910046 — PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES
- K910047 — PATIENT EXAMINATION GLOVES-TEXTURED GLOVES
- K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
- K903135 — CLINI-CALC
- K903439 — DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL
- K903448 — SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
- K903805 — AMICI XENON ADMINISTRATION SET
- K904028 — DCW MODULAR PROXIMAL FEMORAL SYSTEM
- K904051 — RICH-MAR MODEL V ULTRASOUND
- K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION
- K904692 — DB 3000 A-SCAN SYSTEM
- K904711 — BC 1220 ANALOG - IMPLANT BODY
- K904725 — CHLAMYDIA SYSTEM SOFTWARE (CSS)
- K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT
- K904971 — CT HILIGHT ADVANTAGE II
- K904998 — THE BODY COOLER SYSTEM
- K905162 — QUIDEL TOTAL IGE POSITIVE CONTROL SERUM
- K905199 — PACSNET RESEARCH TOOLKIT
- K905231 — DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.
- K905301 — THE THERATEST ACA TEST
- K905836 — ULTRA WAVE 101
- K910055 — ACME MODEL 8500 WHEELCHAIR SCALE
- K902365 — MODULAR UNIPOLAR SYSTEM
- K904662 — SRI JOHANI LATEX SURGEONS GLOVES
- K904665 — MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
- K904806 — CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
- K904886 — VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS
- K904974 — TRACH COLLAR
- K904996 — ABUSCREEN ONLINE TM FOR THC
Data sourced from openFDA. This site is unofficial and independent of the FDA.