FDA 510(k) clearances — page 826
clearances on record, most recent first.
Clearances — page 826
82,501–82,600 of 176,637- K000847 — ORALUBE
- K001980 — ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
- K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
- K001986 — SURGITRON IEC II
- K002039 — ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
- K002146 — KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
- K002346 — WIRE, GUIDE, CATHETER, MODEL QSW1000
- K002399 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K002767 — COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
- K991977 — TYSHAK, MODEL 102 AND Z-MED, MODEL 302
- K000095 — OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
- K000277 — CONSTELLATION CATHETERS
- K000512 — OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
- K000885 — DRX HBA1C - FOR PRESCRIPTION HOME USE
- K001022 — BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
- K001244 — BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
- K001647 — BN PROSPEC SYSTEM
- K001970 — JET 1 POWERED WHEELCHAIR
- K002030 — OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
- K002066 — FREEZER TEETHER
- K002285 — ATAC PAK ALP REAGENT KIT
- K002300 — SUPER 6
- K002302 — SUPER 14
- K002354 — CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
- K002360 — CLOUD CUFF
- K002461 — HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
- K002541 — PROTEIN C REAGENT
- K002770 — IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
- K002793 — KETAC CEM U
- K000975 — LIPIDURE REWETTING DROPS
- K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER
- K001958 — KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH
- K001992 — ILT 0.014 CATHETER, MODEL C114NL2
- K002414 — PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
- K002865 — LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
- K002866 — LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
- K001023 — FREEDOM, MODEL 4660
- K001926 — VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
- K001937 — MEDLINE ELECTRONIC POSITIONING CHAIR
- K001941 — SYNTHES MODULAR FOOT SYSTEM
- K001945 — SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
- K002005 — BOLUSPRO ULTRA
- K002653 — MMN-1 COARSE MANIPULATOR
- K002654 — HOWMEDICA OSTEONICS SHOULDER SCREW
- K002658 — MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
- K002659 — MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
- K000825 — 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
- K001176 — DISPOSABLE MICROKERATOME BLADES-PE
- K002004 — ZYBIT
- K002029 — ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
- K002248 — DINAMAP PRO 1000 MONITOR, MODEL 1000
- K002599 — MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
- K002878 — DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
- K992465 — SOPHY SU8 PRESSURE ADJUSTABLE VALVE
- K000664 — VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
- K001717 — MICOR CONDUCTION CATHETER
- K002242 — POLESTAR N-10
- K002784 — ALOKA UST-5280-5
- K994340 — CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
- K000727 — BUFFLIGHT CLT SURGICAL LASER SYSTEM
- K001093 — CANDELA SPTL-1B PULSED DYE LASER
- K001366 — PROSTEC 125I BRANCHYTHERAPY SNAPSEED
- K001768 — OCCU-FLO PUNCTUM PLUGS
- K001882 — BABY DOPPLEX 4002-TWINS, MODEL BD4002
- K001901 — POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
- K001918 — KSEA PERCUTANEOUS FORAMINOSCOPY SET
- K002073 — PAIN CARE 3000
- K002413 — ULTRASORB SUTURE ANCHOR
- K002678 — ASCENT KNEE SYSTEM
- K002735 — ASCENT XXL OPEN BOX FEMORAL COMPONENT
- K002837 — BIS ENGINE
- K000678 — RAEBBITT/EVOLUTION POWERED WHEELCHAIR
- K001175 — SERAGARD VASCULAR ACCESS PATCH
- K001599 — ACTI-FLEX IV ADMINISTRATION SET
- K001869 — DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
- K002255 — LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
- K002322 — MODIFICATION TO PANAVIA F
- K002329 — PELVX GELLHORN VAGINAL PESSARY 603-608
- K002366 — QUEST MPS BACK-UP SYSYEM
- K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
- K002540 — BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
- K002679 — 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351
- K002750 — HL168T
- K993282 — IPI HUMIDIFIER CHAMBER
- K994420 — POWDER FREE LATEX EXAMINATION PATIENT GLOVES
- K000515 — PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
- K001486 — GENX CODA AIR PURIFICATION SYSTEM
- K001842 — ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
- K002371 — K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
- K002553 — DS DS I-SERIES
- K002685 — CORDLESS COMPACT MOBILE X-RAY SYSTEM
- K002694 — UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
- K980937 — NICORE MODEL ESP -1
- K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
- K002320 — ACCOLADE C FEMORAL COMPONENT
- K002570 — BIO-LOGIC CEEGRAPH NETLINK
- K002734 — ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
- K993933 — 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
- K000138 — MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
- K000139 — MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
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