FDA 510(k) clearances — page 657
clearances on record, most recent first.
Clearances — page 657
65,601–65,700 of 175,825- K050246 — SIS DERMAL AUGMENTATION STRAND
- K050528 — POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)
- K050705 — TIUNITE IMPLANTS
- K050731 — SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
- K050884 — ADAPTER CABLE
- K050907 — FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
- K051000 — FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
- K051079 — HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
- K051126 — CARDIOSCOPE SONOPLUS 3000
- K051182 — INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
- K043542 — BIOPRO TARA FEMORAL RESURFACING COMPONENT
- K050168 — LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
- K050608 — SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
- K050753 — STRYKER DISCMONITOR
- K050754 — PRECIMED CANNULATED SCREW SYSTEM
- K050922 — ANS SCS ACCESSORY KIT
- K050923 — LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
- K050948 — PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
- K050957 — EUTROCHAR
- K051153 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K041059 — EPI-MAX
- K042543 — IPLAN! DIGITAL TEMPLATING
- K042729 — DERMACYN WOUND IRRIGATION
- K042912 — INTERX5000
- K050058 — THEKEN REVEAL VBR SYSTEM
- K050105 — NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
- K050129 — CELLERATION MIST THERAPY SYSTEM 5.1
- K050179 — RANDOX BENZODIAZEPINE CLASS ASSAY
- K050322 — MICROTEK EQUIPMENT DRAPES
- K050499 — PROBLOC, HN SERIES AND PROLONG, PL SERIES
- K050519 — ADVANCED TURBO DRIVE SYSTEM
- K050702 — NEUROSYSTEMS 1TM MONITOR
- K050973 — MODIFICATION TO: VOYAGER LINUX
- K050981 — CD HORIZON SPINAL SYSTEM
- K051002 — ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
- K051096 — APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
- K042610 — DR. THEISS ALERGOL POLLEN BLOCKER CREAM
- K043191 — REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
- K043330 — POLYPROPILENE SURGICAL SUTURES
- K043484 — LANX SPINAL FIXATION SYSTEM
- K050051 — ARMAND ENDOSCOPE HOLDER
- K050315 — DELTA HUMERAL CUPS
- K050418 — TISSUE FIXATION SYSTEM
- K050650 — NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000
- K050741 — IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
- K050900 — MEDIOSTAR XT
- K050983 — IRMA TRUPOINT CREATININE CONTROL KIT
- K051158 — ENCOR 7 GAUGE
- K050594 — NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE
- K050093 — MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
- K050128 — VITALWARE VMS
- K050130 — KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
- K050469 — EZ-STIK ELECTRODES
- K050596 — QUANTIA A1-AT
- K050680 — BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7
- K050717 — PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
- K050788 — EVERLIFE
- K050961 — RNA1C CONTROL FOR NYCOCARD HBA1C
- K051025 — FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- K051076 — ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
- K051090 — X-CHANGE
- K051139 — ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
- K042450 — STERRAD NX CHALLENGE PACK
- K042988 — RAPID ONE STEP BUPRENORPHINE TEST CARD
- K050471 — 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
- K050503 — SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
- K050600 — MINILOC SAFETY INFUSION SET
- K050660 — FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
- K050715 — QUANTA PLEX ANCA PROFILE
- K050749 — ARTHREX TAK FAMILY
- K050780 — BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML
- K050816 — VITEK 2 GRAM POSITIVE MEROPENEM
- K050881 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML
- K050930 — E.P.T. CERTAINTY PREGNANCY TEST
- K051039 — BASIS SPINAL SYSTEM
- K051072 — BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
- K051081 — ESSENPACS
- K051083 — ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
- K041984 — ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
- K043203 — WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
- K043518 — RADIOPAQUE BONE CEMENT
- K050071 — MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE
- K050252 — AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
- K050464 — ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
- K050556 — ALUMINA HEAD
- K050720 — NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
- K050892 — HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
- K050920 — CZR PRESS LF STAINS
- K050937 — TRABECULAR METAL ACETABULAR REVISION SHELLS
- K050959 — DELTON ILLUMINATING PIT AND FISSURE SEALING
- K051100 — MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
- K041823 — PIONEER U121 SERIES CPAP
- K042534 — MARINA MEDICAL FINGER PROTECTORS
- K042977 — LASIK EYE DRAPE
- K042990 — FOR SURE ONE STEP BUPRENORPHINE TEST STRIP
- K043218 — ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
- K043466 — PAINPUMP2
- K050029 — CARDIOMPO TEST
- K050775 — RESSCAN
- K051046 — PAINACEA MODEL XR8 INFRARED HEAT LAMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.