FDA 510(k) clearances — page 658
clearances on record, most recent first.
Clearances — page 658
65,701–65,800 of 175,825- DEN050004 — TAG-IT CYSTIC FIBROSIS KIT
- K042421 — URITEK 151 URINE ANALYZER, MODEL TC-151
- K050116 — UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
- K050312 — AMIGO INSULIN PUMP
- K050541 — OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
- K050786 — BARRIER SURGICAL GOWNS
- K050926 — TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
- K043036 — NON-STICK ELECTRODE
- K043044 — ANTI-I.V. ENTERAL FEEDING SYSTEM
- K043586 — LASER SYS*STIM 540, MODEL ME 540
- K050012 — VENTANA IMAGE ANALYSIS SYSTEM
- K050119 — PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
- K050470 — CONCENTRIC EMBOLIC PEARLS
- K050593 — ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
- K050814 — ATRIUM ICAST COVERED STENT
- K050829 — NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
- K050835 — DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
- K050962 — MERIT PRELUDE SHEATH INTRODUCER
- K051052 — SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
- K041360 — ALDAHOL III HIGH-LEVEL DISINFECTANT
- K041540 — COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
- K043409 — ACCUCHANGER
- K043509 — GUNTHER TULIP VENA CAVA FILTER SET
- K050014 — HEMONIR TM
- K050022 — MEDX HOME
- K050080 — CYNOSUREA ECLILITE AND ECLILITE U
- K050325 — DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
- K050356 — COMPRESSION ANASTOMOSIS RING (CAR)
- K050736 — IMORGON ULTRASOUND PACS SOLUTIONS
- K050756 — SKIPPER AND SKIPPER RACE GUIDEWIRE
- K050812 — 90XL INSTRUMENTATION SYSTEM
- K050874 — ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
- K050890 — ECC.O SYSTEM
- K050934 — MODUS TITANIUM OSTEOSYNTHESIS SYSTEM
- K050941 — BRIX WHEELCHAIR
- K050996 — O-ARM IMAGING SYSTEM
- K051085 — DOPPLER-BOX
- K040145 — ATA HCM MONOPLACE HYPERBARIC SYSTEM
- K040916 — VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
- K042595 — SPIRO'AIR
- K043073 — PROCOTYL-E ACETABULAR SYSTEM
- K043125 — ORION DIAGNOSTICA UNIQ PINP RIA
- K050060 — LAGUNA PEDICLE SCREW SYSTEM
- K050171 — IT NASAL MASK
- K050393 — THE GUIDED SURGERY CONCEPT
- K050484 — BASIS SPINAL SYSTEM
- K050561 — WINDSURFER
- K050573 — NEUROLAC NERVE GUIDE
- K050589 — RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K050612 — LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
- K050686 — CARDIOVIT AT-10PLUS
- K050813 — ABC 2 SCREW
- K050838 — THE LF-P CERAMIC SYSTEM
- K050849 — HA COATED LAG SCREW
- K050853 — PMP4 SPIROPRO
- K050938 — KNEE FUSION NAIL
- K041161 — MICROCYN WOUND CARE DRESSING
- K041184 — NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
- K043005 — MODIFICATION TO MBCP
- K050605 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
- K051077 — E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
- K043084 — PREMERE DELIVERY SHEATH, MODEL PDS
- K050495 — EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
- K050521 — EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
- K050654 — AMSINO I.V. START KIT
- K050656 — AMSINO SUTURE REMOVAL KIT
- K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA
- K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
- K050672 — ERCHONIA EVRL LASER
- K050872 — ACCU-CHEK INTEGRA SYSTEM
- K050990 — REMREST HEATED HUMIDIFIER
- K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
- K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
- K040501 — DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
- K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
- K043245 — EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
- K043604 — LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
- K050274 — DIODENT II DENTAL LASER SYSTEM
- K050350 — THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
- K050369 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
- K050496 — REM440
- K050540 — UCP RAPID DRUG SCREENING TESTS
- K050682 — LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
- K050745 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
- K050747 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML
- K050833 — ELECTRODE JUNCTION BOX, MODEL JE-921A
- K050950 — MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
- K050972 — VISION-SCIENCES ENT-3000 SCOPE
- K050974 — DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS
- K041539 — COMPEL SURGICAL GOWNS
- K041648 — NITI-S STENT & INTRODUCER, MODEL EOXXXX
- K042989 — RX90 LOW PROFILE ACETABULAR SYSTEM
- K043156 — D-CARIE, MODEL N121-M1
- K050401 — CERAMAGE
- K050768 — ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
- K050794 — ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
- K041554 — AIP INTENSE PULSED LIGHT SYSTEM
- K041826 — EKOS ULTRASOUND INFUSION SYSTEM
- K042767 — DATAPRO CLINICAL CHELISTRY ANALYZER
- K043474 — ACCU-CHEK AVIVA SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.