FDA 510(k) clearances — page 828
clearances on record, most recent first.
Clearances — page 828
82,701–82,800 of 175,890- K993697 — DELFIA NEONATAL IRT KIT
- K993701 — PHARMASEED, MODEL BT-125-2
- K994199 — VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
- K000747 — UNIVEC TWO PIECE SYRINGE
- K000792 — CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
- K000798 — TALON BALLOON DILATION CATHETER
- K000813 — FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
- K000815 — AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
- K000817 — OMEGA II MODULAR TOTAL HIP SYSTEM
- K000836 — BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
- K000842 — CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
- K000904 — PENADAPT 10
- K000931 — AU5 ULTRASOUND IMAGING SYSTEM
- K000989 — SPERM WASH MEDIUM, CAT# 2003/2005
- K001046 — BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
- K001261 — L720 EXAMINATION CHAIR
- K001313 — AIRDENT II CS
- K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM
- K001546 — ALLON 2001
- K001602 — DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
- K991137 — ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
- K992980 — ENGAGE JAW INSERTS
- K994074 — TRI-BALL
- K000492 — MDA D-DIMER
- K000535 — QUANTA LITE LKM-1 ELISA
- K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
- K001159 — HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
- K001161 — ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
- K001192 — SELF ADHERING NAVIGUS GUIDE
- K001393 — THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
- K001436 — AGILENT M2636A TELEMON MONITOR
- K001437 — ENSITE 3000 SYSTEM, MODEL EE3000
- K001454 — SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
- K001487 — HARDYDISK CINOXACIN, 100 MCG
- K001548 — MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
- K984376 — ENDOR 2000
- K992221 — ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
- K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
- K992932 — CIPA (ADULTS) CIPI (INFANTS)
- K993066 — WINDOW CERVICAL DYNAMIC PLATE SYSTEM
- K001036 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
- K991206 — BONASSE CONTACT LENS CASE
- K992404 — THE WAND
- K992835 — C.S.O. TONOMETER
- K000001 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
- K000744 — MEDTRONIC AVE BRIDGE X3 STENT
- K000767 — MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
- K000820 — AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
- K000831 — STAT-SHELL DISPOSABLE SP02 SENSOR
- K000882 — DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
- K000998 — OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES
- K001597 — CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
- K990435 — BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
- K993772 — X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
- K993874 — BOFOR REVISION COUP
- K994223 — NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20
- K001148 — MEROGEL OTOLOGIC PACK
- K001627 — TRIFIX SPINAL FIXATION SYSTEM
- K000164 — COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
- K001017 — RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
- K001058 — AUDIOSCREENER OAE + ABR
- K001285 — AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
- K001336 — DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
- K001341 — DR5000 DEDICATED CHEST X-RAY SYSTEM
- K001413 — ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
- K001422 — PSN HEMODIALYZER, MODELS PSN 170, PSN 210
- K001427 — MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K001435 — VIKING OPTIMA GUIDING CATHETER
- K001458 — SYNCHRON CONTROL
- K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES
- K992955 — XPLORER 1000
- K993700 — PHARMASEED, MODEL BT-103-2
- K993895 — OPTIRAD
- K994069 — OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE
- K994106 — OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE
- K994405 — INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
- K000456 — HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2
- K000463 — IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
- K000766 — TRI-FIX SPINAL FIXATION SYSTEM
- K000769 — KSEA MANHES PNEUMOTROCAR
- K000976 — DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
- K000987 — VFSS IMAGER, MODEL SIS-300
- K001004 — WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
- K001005 — WAKO HDL-C/LDL-C CALIBRATOR
- K001014 — ELECSYS ANTI-TPO CALCHECK
- K001201 — MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
- K001209 — INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
- K001489 — HARDYDISK CEFOPERAZONE, 75 MCG
- K001490 — HARDYDISK CEFONICID, 30 MCG
- K993775 — STERRAD BI TEST PACK
- K994116 — LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
- K001367 — FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
- K983068 — RELIANCE FAMILY OF WASHER-DISINFECTORS
- K984231 — ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
- K990331 — SURGEN VALVE
- K991103 — MODIFICATION TO ACIST CL 100H
- K993528 — RUSCH EMERGENCY MASK
- K994274 — QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
- K000719 — NEOCARE 20 MICRON BLOOD FILTER
- K000720 — SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.