FDA 510(k) clearances — page 788
clearances on record, most recent first.
Clearances — page 788
78,701–78,800 of 175,825- K012242 — FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
- K012379 — PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
- K012444 — ABN ANEROID SPHYGMOMANOMETER
- K001245 — 3T L. V. CONTROL VALVE
- K002992 — DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
- K010754 — NURSE'S ASSISTANT O.R. CONTROL SYSTEM
- K011210 — THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
- K011519 — AMEDA HYGIENIKIT
- K011544 — HADGEL, 4 GRAM/SYRINGE
- K011603 — VHS PEDIATRIC HIP SCREW SYSTEM
- K011679 — FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
- K011803 — SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
- K012209 — CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
- K012212 — MODIFICATION TO AEQUALIS SHOULDER SYSTEM
- K012273 — SPIRAL RADIUS 90-D SST SYSTEM
- K012348 — MAXIM RPG PS FEMORAL COMPONENT
- K012391 — MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
- K012394 — ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
- K012395 — MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
- K991822 — ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
- K010118 — NORMED MANDIBULAR FIXATION SYSTEM
- K010399 — DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
- K011504 — BAUMER LOCKING NAIL
- K011550 — HCG STAT PAK ULTRA-FAST
- K011551 — SURE CHECK PREGNANCY TEST
- K011608 — MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
- K011717 — SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
- K011721 — ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
- K011798 — CORERESTORE 2
- K011992 — FHC MICROTARGETING DRIVE SYSTEM
- K012187 — CG-3250 MINIRECEIVER
- K012289 — MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
- K012353 — HNC-127 NEUROVASCULAR ARRAY COIL
- K012407 — PACEART TX3 CARDIAC EVENT RECORDER
- K012452 — MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
- K012454 — MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
- K012458 — MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
- K012459 — MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
- K012460 — MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
- K010242 — COOK ZILVER BILIARY STENT
- K010852 — OSMED TISSUE EXPANDER
- K011184 — INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
- K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
- K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
- K011906 — BACK-UP MEIER GUIDEWIRE
- K012213 — GULLIVER AND CLASSE A
- K003631 — SMARTWAVE IF 2000
- K010039 — QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
- K010544 — VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
- K011024 — CYBERKNIFE SYSTEM
- K011176 — REUSABLE GLASS SYRINGES
- K011467 — ROSS EMBRACE PUMP SET
- K011472 — POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
- K011484 — OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
- K011496 — CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660
- K011513 — MP3U, POWER WHEELCHAIR
- K011607 — SPERMCATCH
- K011621 — KOALA CLAMP, KOALA CLAMP AND CUTTER
- K011840 — CERVILENZ UTERINE MEASURING SOUND
- K011843 — GENZYME DIRECT-AMYLASE TEST REAGENT
- K011928 — HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
- K012073 — OLYMPUS SPRAY CATHETER PW-6C-1
- K012155 — KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
- K012170 — DIGORA PCT
- K012239 — MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM
- K012248 — CHASE CARDIOVASCULAR PATCH
- K012330 — SIMPLICITY EURO QD INFUSION SET
- K012369 — BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
- K012385 — HISPEED X/I SMART GANTRY OPTION
- K012389 — REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
- K002890 — INTRALASE 600C LASER KERATOME
- K003714 — OSSTELL RESONANCE FREQUENCY ANALYZER
- K010702 — XUB EXTERNAL ULTRASOUND
- K010807 — MUSCLE STIMULATOR SA-100
- K011320 — ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
- K011538 — ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
- K011571 — TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
- K011665 — BCT SYSTEM
- K011730 — ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
- K011962 — ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
- K011978 — SYNTHES LCP PROXIMAL TIBIA PLATE
- K012198 — GIBBONS STERILE TROCAR KITS
- K012210 — MODIFICATION TO ACCU-CHEK INFORM METER
- K012355 — IMAGE-X SYSTEM
- K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
- K011444 — ANSPACH EMAX DRILL SYSTEM
- K011935 — REJUVENIQUE MODEL #RJV10
- K012054 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
- K012286 — MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
- K003281 — LACTOSORB RAPIDFLAP
- K011423 — INPULSE DENTAL LASER
- K011459 — WUJIN #3 FEMORAL BONE PLATE
- K011460 — WUJIN #3 TIBIAL BONE PLATE
- K011527 — PRAXSYS RELIA TSH TEST
- K011695 — COLLAGEN DENTAL MEMBRANE
- K011807 — SCS CLARIS SPINAL SCREWS, TYPES V,G,E
- K011822 — PIT AND FISSURE CHEMICAL CURING SEALANT
- K012134 — GC E-LIGHT
- K012215 — QUIK-CHECK HOME PREGNANCY TEST
- K012287 — MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.