FDA 510(k) clearances — page 749
clearances on record, most recent first.
Clearances — page 749
74,801–74,900 of 175,825- K022331 — ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
- K022451 — AUROPAL SOLDER W-2
- K022452 — PORTA OP SOLDER M-1
- K022528 — IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
- K022677 — MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
- K022684 — PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
- K022776 — NESS SYSTEM
- K022831 — MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
- K022875 — MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
- K022876 — MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
- K021334 — WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
- K021623 — UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
- K021929 — AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
- K021985 — MEDX LCS LASER SERIES
- K022037 — XLTEK SLEEP SYSTEM
- K022104 — DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
- K022127 — AVAGEN WOUND DRESSING
- K022158 — IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
- K022230 — NORMED MINI EXTERNAL FIXATOR SYSTEM
- K022664 — PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
- K022782 — DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
- K013705 — ACT III VENTRICULAR CATHETER
- K020631 — IPLAN
- K020972 — WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
- K021218 — ELECSYS CORTISOL TEST SYSTEM
- K022175 — P4 PHYSIO
- K022182 — MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
- K022273 — CRANIAL SYMMETRY SYSTEM
- K022323 — NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
- K022325 — NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
- K022833 — BENJAMIN ENVOY PHACO HANDPIECE
- K011531 — CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
- K020345 — ARTHREX UNIVERS FRACTURE PROSTHESIS
- K021278 — EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
- K021890 — G-2 VERSION 3, MODEL 10049
- K021893 — G-MOPS, MODEL 10030
- K021894 — G-MM, MODEL 10038
- K021896 — HSA-SOLUTION, MODEL 10034/10064
- K021913 — CALSCOR SOFTWARE
- K021928 — SYNTHES (USA) RESORBABLE FIXATION SYSTEM
- K021931 — ENDOSCOPIC FIBEROPTIC CABLE
- K021932 — SYNTHES 6.5 MM CANNULATED SCREW
- K022097 — THERMIQUE
- K022180 — DIRECT BILIRUBIN
- K022229 — SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
- K022244 — G-1 VERSION 3, MODEL 10048
- K022245 — G-FERT, MODEL 10033
- K022247 — G-SPERM, MODEL 10032
- K022408 — CEREC VITABLOCKS MK2
- K022618 — X-SCRIBE II
- K022619 — POWDER FREE NITRILE EXAMINATION GLOVES
- K022635 — KUSKE BREAST APPLICATOR SET, MODEL 189.006
- K022649 — COOK-SWARTZ DOPPLER FLOW PROBE
- K022658 — LR DICOM CONTROLLER
- K022669 — 8 CHANNEL CARDIAC PHASED ARRAY COIL
- K022720 — CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
- K022726 — STAYFUSE GT-IP
- K022735 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
- K022789 — VIATRONIX V3D EXPLORER
- K022796 — CERCON CERAM S PORCELAIN
- K022858 — SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
- K022890 — MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K020647 — DIDECO ELECTA
- K020693 — AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
- K021875 — MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
- K021891 — ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
- K021905 — CLASSIC NMS
- K022312 — PICCOLO PHOSPHORUS TEST SYSTEM
- K022368 — DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E
- K022431 — MEDRAD TRANSFER SET
- K022442 — POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)
- K022502 — INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
- K022647 — HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
- K022648 — ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
- K022766 — SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
- K021906 — QUINTON Q-CATH, MODEL 000460
- K021907 — IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K022588 — HRW-63-INT WRIST ARRAY COIL
- K022621 — BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
- K002612 — BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
- K021843 — EYEFEEL OPHTHALMIC WARMER
- K021847 — BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
- K021848 — CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160
- K021948 — LUCIUS 62
- K022005 — SYNTHES MIDFACE DISTRACTOR
- K022042 — MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
- K022088 — SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
- K022090 — SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
- K022092 — SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
- K022146 — SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
- K022767 — RAICHEM LIPID CALIBRATOR
- K020607 — SLEEPFLO, MODEL 101501
- K021083 — VERACAM
- K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- K021265 — DATEX-OHMEDA HMEF 500
- K021355 — ENDOSSEOUS IMPLANT
- K021493 — ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
- K021781 — EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
- K021837 — BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
- K022543 — ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.