FDA 510(k) clearances — page 769
clearances on record, most recent first.
Clearances — page 769
76,801–76,900 of 176,637- K021024 — HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- K021031 — EBI XFIX RAIL SYSTEM
- K021092 — PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
- K021145 — ACCOMMODATOR WHEELCHAIR, MODEL #2000X
- K021192 — QACA IGG/IGM ELISA KIT HRP
- K021232 — CONSTELLATION CATHETERS, MODEL 8031M
- K021242 — PORTALLOY 54
- K021367 — STERNGOLD 66, MODEL #1180230
- K021371 — SUNSPEX TECHNOLOGIES MODEL SE 02
- K021382 — SYNTHES (USA) AUTOMATED TACK DRIVER
- K021396 — DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
- K021514 — PHILIPS PLS9W/12/2P UVB
- K020538 — BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
- K020633 — NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
- K020652 — HERNIAMESH T-SLING
- K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
- K020771 — ACON ONE STEP DRUG SCREEN TEST CARD
- K020840 — VITAL SCIENTIFIC PT WITH CALCIUM
- K020842 — ERTAPENEM 10UG BBL SENSI-DISC
- K020859 — CEFOTAXIME
- K021042 — THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476
- K021107 — FORTAFLEX SURGICAL SLING
- K021132 — UNI-PATCH ULTRASOUND COUPLING GEL
- K021175 — AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
- K021215 — BIO-LOGIC ABAER CUB
- K021228 — HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
- K021249 — SURGASSIST FLEXSHAFT 2, MODEL FS2 14
- K021263 — MODIFICATION TO SPARC SLING SYSTEM
- K021368 — MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
- K021422 — PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
- K012658 — REPROCESSED COMPRESSION LIMB SLEEVES
- K013587 — BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
- K013787 — NYCOCARD CRP
- K013840 — MICROJET CRONO PAR AND CRONO APO-GO
- K014278 — LATEX SURGEONS GLOVE (POWDERED)
- K020355 — I-STAT PROTHROMBIN TIME TEST
- K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
- K020618 — AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
- K020664 — STERISHARP 3-GALLON RSDC, MODEL RSDC3G
- K020713 — MS-30 LATERAL FEMORAL STEM
- K020816 — IRON-PC-SL ASSAY MODEL # 151-10, 151-26
- K020823 — PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
- K021022 — HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
- K021023 — HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
- K021058 — SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
- K021059 — SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
- K021178 — SL-PLUS LATERALIZED STEM
- K021296 — SIMPLICITY QD EASY P INFUSION SET
- K021308 — GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
- K021350 — ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
- K020579 — AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
- K020615 — SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
- K021126 — EVERSTICK ORTHO
- K021182 — RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
- K021226 — MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
- K021246 — SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
- K021395 — MODIFICATION TO 30 EXTENSION SET
- K021416 — AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
- K013886 — AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
- K020254 — PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
- K020445 — THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
- K020449 — CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM
- K020453 — PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER
- K020617 — NSI HEXED AND NON-HEXED IMPLANT SYSTEM
- K020692 — EMIT 2000 VANCOMYCIN ASSAY
- K020719 — SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
- K020763 — COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
- K021105 — FORTAFLEX SURGICAL MESH
- K021163 — OCTEIA 25-HYDROXY VITAMIN D
- K021258 — GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
- K021413 — AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
- K012132 — CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
- K013053 — MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
- K013855 — MICROJET CRONO H
- K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
- K020535 — INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
- K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- K020561 — SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
- K020566 — FUJIREBIO DIAGNOSTICS CA 19-9 RIA
- K020709 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K020724 — DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
- K020762 — GATIFLOXIN
- K020820 — MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
- K020944 — VORTEX VALVED HOLDING CHAMBER
- K021054 — CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER
- K021135 — MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
- K021166 — ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
- K021339 — HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
- K012712 — NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
- K012979 — COMPRESSIBLE LIMB SLEEVE
- K013376 — QFLOW 500 PERFUSION MONITORING SYSTEM
- K013822 — MICROJET CRONO PCA
- K020203 — PADPRO MODEL #2516
- K020313 — ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
- K020401 — SYNTHES CALCANEAL PLATE
- K020466 — HEC 1000
- K020634 — MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
- K020723 — DIMENSION ALDL CALIBRATOR, MODEL DC131
- K020788 — WILSON-COOK ZILVER BILIARY STENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.