FDA 510(k) clearances — page 391
clearances on record, most recent first.
Clearances — page 391
39,001–39,100 of 176,542- K131612 — ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES
- K132075 — PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)
- K132315 — ERGONOMIC PRODUCTS WORKSTATION
- K132406 — ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
- K132679 — AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
- K133397 — P-POD
- K133534 — MCKESSON CARDIOLOGY ECG MOBILE
- K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
- K133624 — COMPASS CT, COMPASS CT PORT
- K133915 — GALAXY CO2 LASER SYSTEM
- K133922 — GENTLECARE AR APPLICATOR
- K133941 — MITEK ARTHROSCOPES
- K133998 — ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
- K140375 — MASTERGRAFT PUTTY, MASTERGRAFT STRIP
- K140474 — JULIET OL
- K140625 — ORTHOSORB LS
- K131189 — UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
- K131660 — SMART (SMART-D, SMART-DX)
- K131852 — HC-1 AND HC-1 CLASSIC
- K131962 — DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
- K132547 — ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
- K132724 — ICONN ANSWER SUTURE ANCHOR
- K132789 — FLIP INTRODUCER ACCESS KIT
- K132976 — ADVATX
- K133006 — NEOV DIODE LASER FAMILY
- K133270 — SPEED ARC
- K133421 — STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
- K133522 — RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
- K133589 — SOMATOM FORCE
- K133802 — AIS MODULIFT VBR SYSTEM
- K133823 — NUFACE MINI DEVICE
- K140321 — INITARY BETTER BLADDER-PEDIATRIC
- K140397 — PARALOCK PLATING SYSTEM / TUFFNEK SCREW
- K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH
- K140495 — LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
- K140715 — ZIP MIS INTERSPINOUS FUSION SYSTEM
- K140745 — ENCORE 26 ADVANTAGE KIT
- K140769 — VARIAX 2 SYSTEM
- K140808 — Q-STATION
- DEN140005 — LYRA DIRECT STREP ASSAY
- K132620 — INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
- K133524 — PVMED DDR 2430T
- K133707 — SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
- K133783 — AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
- K133791 — ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
- K133815 — INTESS CERVICAL CAGE SYSTEM
- K140092 — CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
- K140288 — TRUEPATH CTO DEVICE
- K140396 — FREELITE HUMAN LAMBDA FREE KIT
- K140475 — ROTATING ADAPTERS
- K140639 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
- K140664 — HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
- K140673 — INSERTION TOOL
- K132738 — COGENT MED-LIF
- K133389 — EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
- K133905 — 6200 / 6250 ULTRASOUND SYSTEM
- K140503 — FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
- K140831 — MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
- K130778 — DISCOSCOPES, CERVICAL ENDOSCOPES
- K130852 — AVANCE® FOAM ABDOMINAL DRESSING KIT
- K132930 — MYHEALTHPOINT TELEHEALTH MANAGER
- K132940 — ERCHONIA ALLAY
- K132999 — CERVICAL STAND ALONE SYSTEM
- K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
- K134010 — CABOCHON SYSTEM
- K140191 — ELISIO-H HEMODIALYZER
- K140194 — NAMIC RCS SYRINGE
- K140219 — PICASSO II MIS SPINAL SYSTEM
- K122176 — POWDERED VINYL EXAMINATION GLOVES
- K122377 — POWDER FREE VINYL EXAMINATION GLOVES
- K131734 — ALL-BOND UNIVERSAL SC (NOT FINALIZED)
- K131883 — AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
- K131906 — SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
- K132138 — RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
- K132312 — RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
- K132478 — AIR-FLOW HANDY 3.0
- K132596 — PROPOSED OPTIMUS
- K133340 — SPINEWORKS ANTERIOR LUMBAR DEVICE
- K133345 — REVEEL ENDOSCOPIC RETRACTOR
- K133521 — AZE PHOENIX SOFTWARE
- K133705 — REVOLUTION CT
- K133781 — DECLIPSESPECT LAPAROSCOPY
- K133923 — MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
- K133932 — INION FREEDOMPIN
- K134015 — M-PM-DISC
- K134039 — DAYTONA ICG (P200TICG)
- K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
- K140645 — GIBRALT ROD-TO-ROD CROSS CONNECTORS
- K140646 — DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
- K131028 — PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
- K131902 — PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
- K131944 — IEEG
- K132208 — ONTEX AND OTHERS PROPRIETARY NAMES
- K132284 — VECTRA NEO CLINICAL THERAPY SYSTEM
- K132290 — SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
- K132825 — RETROMTA-ORTHOMTA II
- K132934 — MULTIX SELECT DR
- K133045 — ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
- K133238 — CONTOUR I V3.1 SYSTEM
- K133578 — REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.