FDA 510(k) clearances — page 1434
clearances on record, most recent first.
Clearances — page 1434
143,301–143,400 of 175,890- K862065 — PC-PLAN
- K862638 — VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
- K862856 — PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
- K862980 — OTICON I31 CITE HEARING AID
- K863026 — PULMANEX TM (MODIFICATION)
- K863097 — CB BUR
- K863131 — PIK POCKET (IRRIGATING TIP)
- K863141 — KULZER GLASS IONOMER LINER
- K863196 — BUN (RATE) REAGENT
- K854607 — ACCULEVEL PHENOBARBITAL TEST
- K855026 — ACCULEVEL PHENYTOIN TEST
- K860289 — PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER
- K860488 — OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
- K860973 — CIRCADIAN STRESS TEST SYSTEM
- K861031 — WYLER SPHENOIDAL ELECTRODE
- K861059 — DAKO ITA SYSTEM
- K861504 — MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
- K861538 — 860 COLOR DOPPLER OR COLORVIEW 860
- K861900 — LIFESCAN EVOKED POTENTIAL SYSTEM
- K861981 — ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
- K862056 — [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
- K862182 — AMNIOINFUSION CATHETER
- K862244 — MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
- K862379 — CORNEAL MODELING SYSTEM
- K862526 — MINI-HOLTER, MODEL 2000
- K862748 — MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION
- K862880 — SARA RT
- K862953 — CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
- K862971 — MICRA MICROSURGICAL INSTRUMENTS
- K861746 — KEELER DUAL LIGHTSOURCE
- K861747 — KEELER FIBEROPTIC HEADLAMP
- K862106 — FORMOSTAR
- K862188 — IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
- K862213 — PRESSURE CONTROL VALVE & TUBING CAT. NO. 83-1010
- K862321 — CELLMATICS RSV DETECTION SYSTEM
- K862323 — CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
- K862641 — U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
- K862692 — KARICKHOFF DIAGNOSTIC/LASER LENS
- K862713 — ABRAHAM IRIDECTOMY LENS (YAG LASER)
- K862719 — SOLARSHIELDS
- K862728 — HOSKINS NYLON SUTURE LASER LENS
- K862739 — INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES
- K862858 — CBC-CAL (TM) PLUS/MULTIPLE
- K862868 — ABRAHAM YAG LASER LENS
- K862869 — PETRUS SINGLE MIRROR LASER LENS
- K862943 — SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
- K862957 — MERIVAARA GERIATRIC CHAIR MODEL 455
- K862989 — SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
- K863027 — SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS
- K863118 — I.D.C. STANDUP WHEELCHAIRS
- K854662 — OEE_7102 EEG/TREND MONITOR
- K854663 — NEUROFAX 7310 SERIES (EEG)
- K860009 — 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM
- K861014 — AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
- K862228 — CABOT LASER LAPAROSCOPY ACCESSORY SET
- K862831 — MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
- K862935 — WOUND MANAGER(TM) - STERILE
- K862945 — DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
- K862961 — MODIFIED SURGICAL STARTER KIT
- K862993 — PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT
- K862994 — PORTABLE ISOKINETICS 3002 ISO KANE II
- K862995 — PORTABLE ISOKINETICS 3003 SHOULDER UNIT
- K862996 — PORTABLE ISOKINETICS 3004 KNEE UNIT
- K862997 — PORTABLE ISOKINETICS 3005 HIP UNIT
- K862998 — PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT
- K863033 — PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
- K860325 — PRISTINE CULTURE CATHETER
- K860462 — SEAMED MODEL 3000
- K860823 — ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
- K860909 — WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)
- K861508 — WAKO MICRO TP
- K861623 — MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER
- K861697 — SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
- K861966 — MODIFIED IDEIA CHLAMYDIA TEST
- K861970 — LYPHOCHEK URINE TOXICOLOGY CONTROL
- K862108 — ENZYMUN-TEST HCG
- K862115 — DEKNA BAND KIT
- K862183 — DAKO ITA, IMMUNOGLOBULIN A (IGA)
- K862184 — DAKO ITA, IMMUNOGLOBULIN M (IGM)
- K862227 — MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
- K862266 — MAPLE ALLERGEN DISC
- K862288 — MODIFICATION OF TISSUE DILATOR
- K862306 — KING DIAGNOSTICS LDH TEST
- K862320 — DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
- K862355 — TRANS-PULSE MODEL #1103
- K862357 — MODIFIED CARDIOTOMY RESERVOIR 5M1470
- K862359 — METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
- K862364 — NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
- K862428 — STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
- K862439 — SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
- K862453 — EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
- K862525 — EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
- K862594 — SERACON(TM) CAL (PRODUCT NO. DO35)
- K862603 — DOUBLE ANTIBODY ESTRADIOL RIA KIT
- K862700 — SERATEST ENA [SS-B] KIT
- K862701 — SURESPOT
- K862704 — EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
- K862706 — EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
- K862707 — EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
- K862817 — V-TREND QC TDM CONTROL SERUM 1,2,3.
Data sourced from openFDA. This site is unofficial and independent of the FDA.