FDA 510(k) clearances — page 836
clearances on record, most recent first.
Clearances — page 836
83,501–83,600 of 176,637- 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
- 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
- K001108 — PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
- K001264 — EAGLE ENDO SPECIMEN RETRIEVAL BAG
- K001302 — ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
- K001330 — SOVEREIGN BIPOLAR INSTRUMENTS
- K993010 — BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
- K993991 — HM-930 ELECTROSURGICAL UNIT
- K000215 — SWIVEL ELBOW
- K000500 — DINAMAP ADVANCED NIBP MODULE
- K000669 — MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
- K000673 — HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
- K000738 — WHEELCHAIR, MODELS H001A, 4422
- K000795 — RIGID GAS PERMEABLE CONTACT LENS
- K000802 — SPIRAL IMAGING OPTION
- K000960 — BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
- K000973 — BEHRING COAGULATION SYSTEM (BCS)
- K000993 — LIBERTY 9000 BREAST COIL
- K001203 — OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
- K001253 — SURGITRON IEC II
- K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM
- K001397 — QUICKSCREEN PRO DRUG CUP, MODEL 9195X
- K001428 — OPTIMUM WETTING AND REWETTING DROP
- K001429 — MODIFICATION TO ACCUDEXA BONE DENSITOMETER
- K992668 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
- K994260 — CANDELA GENTLELASE GL DERMATOLOGICAL LASER
- K994329 — IIVS INTEGRATED IMAGE VIEWING STATION
- K000633 — SYNTHETIC GLASS BONE GRAFT MATERIAL
- K000639 — VISIONARY 2000
- K000680 — VISION ESTHETIC PORCELAIN SYSTEM
- K000686 — KROM-ALGINATE AND ALGINATE PLUS
- K000937 — IVC TWO MEDIUM
- K000938 — IVC ONE MEDIUM
- K001373 — LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
- K992085 — ABBOTT IMX GLYCATED HEMOGLOBIN II
- K993484 — Q-HTF, CAT# 2001
- K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
- K993877 — NELSON WATER SYSTEMS FOR HEMODIALYSIS
- K000645 — GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
- K000922 — PROTON VISION
- K000958 — ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
- K001002 — WAKO LIPASE CALIBRATOR
- K001243 — DORNIER MEDILAS H
- K001256 — CONTROL PLASMA N
- K001346 — ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
- K991894 — BIOSCANNER TRIGLYCERIDES TEST STRIPS
- K993355 — HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
- K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
- K000178 — NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
- K000604 — NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
- K000609 — CARDTEL, MODEL NT-100
- K000625 — SCANDINAVIAN IVF SCIENCES AB, G1.2
- K000626 — SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
- K000760 — REACH FEMORAL COMPONENT
- K000957 — HOFFMANN II EXTERNAL FIXATION SYSTEM
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