FDA 510(k) clearances — page 367
clearances on record, most recent first.
Clearances — page 367
36,601–36,700 of 175,770- K142563 — Well Lead PVC Urethral Catheter
- K142654 — Fortrex 0.035 OTW PTA Balloon Catheter
- K142733 — E-CUBE 5
- K142884 — E-CUBE 12
- K142900 — Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
- K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
- K140940 — PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
- K141331 — BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
- K141407 — VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
- K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
- K141850 — FLOSPINE PEDICLE SCREW SYSTEM
- K141953 — ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
- K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
- K142114 — Xia® Growth Rod Conversion Set
- K142425 — Uroflowmeter
- K142847 — CD HORIZON Spinal System
- K133069 — CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
- K133225 — E-FIT EF-1280 EMS MACHINE
- K140022 — NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
- K140647 — XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
- K140684 — CLINPRO PROPHY POWDER
- K140927 — UNIVERSAL NAVIGATION INSTRUMENTS
- K141175 — RENOVOCATH RC120
- K141564 — OPTON PRO
- K141714 — PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
- K141731 — NEPHROS DSU-H, NEPHROS SSU-H
- K141759 — OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
- K142079 — STALIF CTI, STALIF C
- K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
- K142574 — 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,
- K142727 — CrossCLIP Implant System
- K142784 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
- K131737 — SUPERNOVA C5 MRI SYSTEM
- K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
- K140205 — PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
- K140754 — COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
- K141125 — U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
- K141325 — TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
- K141339 — ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
- K141560 — ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
- K141816 — HEMOPORE
- K141860 — RAYSTATION
- K142101 — ABACUS (TM) SPACER SYSTEM
- K142359 — Vasc Band hemostat
- K142556 — Flexible Video-Uretero-Choledochoscope System
- K142603 — Stryker Precision HD Camera System
- K142698 — PerkinElmer, XRpad 4343 F MED Flat Panel Detector
- K142755 — Siemens 3.0 Blanket Array Coil
- K142757 — LiNA PowerBlade Plus HC
- K142876 — ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
- K133849 — VANTERA CLINICAL ANALYZER
- K140251 — UNIVERSAL DIGITAL INTERFACE 2, UDI 2
- K141211 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
- K141491 — SOLITAIRE 2 REVASCULARIZATION DEVICE
- K141544 — ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
- K141603 — Ultra Silver Dressings
- K141658 — LIGHT SCALPEL
- K141723 — UPCERA COLORING LIQUID (I AND II )
- K141724 — UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
- K141908 — DUAL SWITCH
- K142281 — ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
- K142579 — Zimmer Periarticular Plating System
- K142602 — VALOR Hindfoot Fusion Nail System
- K142670 — Vericore Zirconia Blanks
- K142708 — VERADIUS UNITY
- K140197 — PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
- K141604 — CD HORIZON SPINAL SYSTEM
- K141651 — SENSITITRE SUSCEPTIBILITY PLATES
- K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIRE
- K141904 — VIORA V-TOUCH
- K142003 — FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
- K142042 — ERCHONIA SHL
- K142381 — Xia 3 Spinal System
- K132490 — SKORE AND MULTIPLE BRANDS
- K140236 — AILERON INTERSPINOUS FIXATION SYSTEM
- K140268 — SIMPLE T YOUTH NASAL MASK
- K140993 — IONOSTAR MOLAR
- K142026 — SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
- K133360 — AERONEB SOLO; AERONEB SOLO ADAPTER
- K140472 — BONASTENT TRACHEAL / BRONCHIAL
- K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
- K140728 — MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR
- K140783 — HALO AMBULATORY INFUSION SYSTEM
- K140929 — Z1 CPAP SYSTEM
- K141152 — ADVANTAGE
- K141165 — MATRIXWAVE MMF SYSTEM
- K141242 — GLIDE DEVICE
- K141335 — EXPEL APD DRAINAGE CATHETER SYSTEM
- K141344 — EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
- K141426 — ELECSYS FOLATE III
- K141579 — EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
- K141600 — NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
- K141742 — ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
- K141917 — UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR
- K142091 — PARIETENE MACROPOROUS MESH
- K142096 — T-PIECE RESUSCITATOR
- K142220 — Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
- K142252 — XprESS Multi-Sinus Dilation Tool
- K142267 — Sherlock 3CG Tip Positioning System Stylet
- K142589 — Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL
Data sourced from openFDA. This site is unofficial and independent of the FDA.