FDA 510(k) clearances — page 1505
clearances on record, most recent first.
Clearances — page 1505
150,401–150,500 of 175,890- K845026 — AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
- K850008 — SOPHEIA/MP CORTISOL EIA KIT
- K850032 — A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD
- K850128 — SYSTE MATE TIBC HEM NO. 67225
- K850136 — CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM
- K850253 — ECONO MATE -OXYGEN CONCENTRATOR
- K843643 — COLOR DOPPLER 880
- K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
- K842466 — TITANIUM MITTELMEIER TYPE ACETABULAR
- K842518 — UNILOC-CEMENTLESS & SELF TAP ACETABULAR
- K844499 — MEDSENTRY SOFTOUCH SYSTEM
- K844552 — BIO-STAT III PLATE WASHER
- K844568 — TITERTEK DULUTER/DISPENSER 78-640-00
- K844571 — CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE
- K844634 — PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS
- K844640 — POLYSTAT, BIOLOGICAL STAIN
- K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER
- K842216 — CULTURESET HSV ISOLATION & ID SYS
- K843138 — CMV TEST
- K844093 — JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
- K844610 — PERRY SUTURING SET W/ANESTHETIC
- K844832 — WETS & DRIES
- K850110 — VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
- K843781 — KINAIR, LOW AIR LOSS BED
- K843899 — GRC-WT, GRC-W
- K844627 — STRATOFUSE SYRINGE PIGGYBACK PUMP
- K844718 — MODEL 1001
- K844719 — 360 INFUSER
- K844730 — BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
- K844820 — FLOW MED SK 140 BURET
- K845020 — SYSTE MATE IRON, HEM NO. 67224
- K845023 — STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000
- K841048 — TRANSDUCER 4.OMHZ LA4011
- K843544 — THE BIBICURE SYS BREAST TONER
- K843609 — ELEX ELECTRONIC DIGITAL THERMOMETER
- K844091 — ABBOTT LIFECARE 900 VOLUMETRIC PUMP
- K844200 — K.M. PRODUCTS ASPIRATOR
- K844407 — DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
- K844768 — ABBOTT LIFECARE 500 INFUSER
- K844879 — HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
- K844880 — HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
- K844937 — IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
- K841254 — CARDIOVIT CV-3
- K844228 — PDS POLYDIOXANONE MESH
- K844279 — INTERCEPTOR, 662-01
- K844352 — SUNDT-KEES REINFORCING ANEURYSM CLIP
- K844584 — GORE-TEX TUNNELER
- K844811 — PACE AID MODEL 53
- K850066 — OMNIMED NASAL OXYGEN CANNULA
- K850106 — AIRCO NITROUS OXIDE REGULATOR
- K850111 — AIRES TUOHY NEEDLES 17GA. X 4 1/2
- K842705 — MX2 ELECTRONIC STETHOSCOPE
- K843246 — HEARING AID, UNITRON UE12-PPL
- K843370 — IMSI/METRIPOND GRIPPER PLATE
- K843484 — MECON X (TEN)
- K843969 — MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
- K844034 — SONOCARE
- K844048 — DR. HESSEL'S INSECT POISON REMOVER
- K844052 — BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
- K844064 — MEDO BUBBLE BATH MA-80, 400, 600 & 700
- K844076 — ELECTRO-NERVE STIMULATOR B5/SK700B
- K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
- K844157 — HOLDSTER ARM RETENTION SYSTEM
- K844176 — PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS
- K844247 — ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
- K844250 — OSADA ENAC
- K844347 — FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
- K844415 — POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
- K844449 — HIGH RESOLUTION 5 MHZ LINEAR ARRAY
- K844472 — CIVCO SCAN DRAPE
- K844477 — STORZ CORNEO-SCAN II CS2000
- K844728 — ADVANCED HEARING INSTRUMENTS - HEARING AIDS
- K844744 — CARDIO IV/GXT STRESS TESTING SYSTEM
- K844836 — HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
- K844837 — VISISTAT SKIN STAPLING DEVICE
- K844838 — SKIN STAT II SKIN STAPLING MEDICAL DEVICE
- K844985 — IN THE EAR MODEL X-ITE 84
- K844990 — SYVA ADVANCE EMIT PHENYTOIN ASSAY
- K844991 — EMIT PHENYTOIN ASSAY
- K850014 — HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE
- K850016 — TOWEL PACK, SURGICAL
- K844132 — MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER
- K844227 — INFUSART
- K844309 — IV RATEMETER
- K844313 — INFUSET W/HUBER NEEDLE
- K844500 — TITERTEK MICROPLATE WASHER 120
- K844650 — DR-2C
- K844694 — TITMUS VISION TESTER II
- K844715 — VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
- K844748 — NEPHROSS ALLEGRO H.F.
- K844792 — MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
- K844851 — MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
- K844898 — CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
- K850070 — HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
- K841190 — MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
- K841392 — BIOMATT-1
- K842031 — TRANSVENOUS TINED VENTRICULAR/ATRIAL
- K842032 — MODELS 4012/4512 TRANSVENOUS TINED-
- K842065 — EPICARDIAL, UNIPOLAR LEAD 4951
- K842122 — 4A
Data sourced from openFDA. This site is unofficial and independent of the FDA.