FDA 510(k) clearances — page 378
clearances on record, most recent first.
Clearances — page 378
37,701–37,800 of 175,770- K132891 — HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
- K133087 — ABBVIE PEG
- K133129 — ABBVIE NJ
- K133258 — TRUFREEZE SYSTEM
- K140370 — DISPOSABLE PRESSURE MANOMETER
- K140510 — MIROMATRIX WOUND MATRIX
- K140644 — PROCEM
- K140678 — COSMOLOCK PEDICLE SCREW SYSTEM
- K140937 — OSSEOFLEX SB
- K130581 — KONIX STERILE GEL
- K130733 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K133096 — ABB VIE J
- K133295 — QUALIS
- K140067 — QARDIOARM
- K140583 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES
- K141029 — TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
- K141313 — REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
- K141363 — CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
- K132833 — ULTRA RENEW PLUS
- K133635 — EASYPOINT NEEDLE
- K140159 — S9 WANDA VPAP ST
- K140441 — BI-FLEX URETERAL ACCESS SHEATH
- K140450 — KEELER KAPTURE SOFTWARE
- K132289 — GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
- K133439 — PILLING ESOPHAGEAL BOUGIES
- K133965 — OTC EMS STIMULATOR
- K140006 — ENDOSHIELD BURN PROTECTION SYSTEM
- K140073 — U2 FEMORAL COMPONENT, CR, CEMENTED
- K140134 — ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
- K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
- K140317 — EMBRYOGEN
- K140443 — ARIETTA 60/ARIETTAS60/ARIETTAV60
- K140519 — RECOVERY PUMP 737R
- K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE
- K140570 — CHAIRSIDE ATTACHMENT PROCESSING MATERIAL
- K140623 — NXSTAGE EXPRESS FLUID WARMER
- K140708 — VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
- K140713 — PLANMECA ROMEXIS
- K140760 — BONASTENT BILIARY
- K140992 — ARTHROCARE NASASTENT CMC NASAL DRESSING
- K132566 — REPROCESSED HARMONIC SHEAR
- K122807 — DENTAL IMPLANT SYSTEM
- K131080 — PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE
- K132003 — WINX SLEEP THERAPY SYSTEM
- K132524 — CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
- K132816 — ONCENTRA BRACHY
- K132978 — IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
- K133098 — SENYINT PACS
- K133553 — KALARE
- K133661 — CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
- K133884 — BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM
- K140075 — U2 FEMORAL COMPONENT, CR, POROUS COATED
- K140312 — EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
- K140430 — 740 SELECT
- K140437 — SU-POR SURGICAL IMPLANT
- K140462 — MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
- K140666 — MR ELASTOGRAPHY
- K140759 — BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
- K140799 — CELERITY SYSYEM
- K140960 — PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K141055 — LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
- K141383 — ACUMED HAND FRACTURE SYSTEM
- K141520 — ALERE I INFLUENZA A & B
- K132375 — GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
- K133280 — TERUMO SURFLO I.V. CATHETER
- K140239 — JIAWANG
- K140240 — ZHAOFENG
- K140242 — FEIYUE
- K140314 — WARTIE WART REMOVER
- K140322 — WHITE VINYL EXAM GLOVES POWDER FREE
- K140361 — META-C CERVICAL PLATE
- K140695 — COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
- K140730 — VIAL2BAG DIRECT CONNECT
- K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
- K141306 — TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE
- K141360 — TRIPLEPLAY PRO
- K141381 — DURADIAGNOST
- K131858 — DIGITAL ELECTROCARDIOGRAPH
- K132954 — JO PREMIUM PERSONAL LUBRICANT
- K133132 — OPTICAL BIOMETER AL-SCAN
- K133403 — FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS
- K134022 — BASE IT
- K140425 — CONTRAST MODULATION SYSTEM
- K140651 — CELESTEION, PCA-9000A/2
- K140662 — FLEX ENDOSCOPIC INSTRUMENTS
- K140854 — INTRA-OPERATIVE ULTRASOUND TRANSDUCER
- K140955 — MTA2.1 MATERIAL
- K140996 — MAMMI
- K141250 — FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
- K132920 — SPIROX INEX DEVICE
- K133297 — QUADROSTARPROGREEN, QUADROSTARPROYELLOW
- K133494 — CHESAPEAKE SPINAL SYSTEM
- K133770 — A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
- K134021 — ESTEMP IMPLANT, ESTEMP CLEAR
- K140138 — HEARTNAVIGATOR RELEASE 2.0
- K140331 — ORTHALIGN PLUS SYSTEM
- K140374 — MASTERGRAFT PUTTY
- K140521 — TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH
- K140642 — PCD 737A
- K140675 — EMERGE EXTERNAL FIXATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.