FDA 510(k) clearances — page 383
clearances on record, most recent first.
Clearances — page 383
38,201–38,300 of 175,770- K133007 — DX3000-L
- K133278 — DISCOVERY IGS 740
- K133870 — FLUID LEVEL MONITOR
- K134013 — LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
- K140080 — ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
- K140123 — POLARIS SPINAL SYSTEM -TRANSLATION SCREW
- K140763 — MONOFILAMENT POLYPECTOMY SNARE
- K131889 — EUM 100PRO
- K132077 — PATIENT MONITOR
- K132549 — ACCUTIP COVER
- K132595 — ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
- K133009 — NASAL MASK, NASAL MASK, FULL FACE MASK
- K133742 — XQ-1 INCUBATOR
- K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT
- K133897 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
- K140010 — FORTRESS PEDICLE SCREW SYSTEM
- K140445 — DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
- K140561 — AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
- K132390 — INSTINCT; PLAIN, DOTTED, ULTRA THIN
- K133649 — HEPATIC VCAR
- K133761 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
- K133829 — AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
- K140147 — BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
- K140442 — MEDSOURCE SELECTABLE IV SET
- K140560 — ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
- K140303 — ALAMO T
- K140307 — ENVOY GUIDING CATHETER
- K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.