FDA 510(k) clearances — page 412
clearances on record, most recent first.
Clearances — page 412
41,101–41,200 of 176,542- DEN130013 — VITEK MS
- K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
- K130627 — SWING-OFF SCREW
- K130696 — CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
- K131158 — CORVIEW
- K131391 — JUSHA-M32 MEDICAL DISPLAY
- K131584 — IMDX FLU A/B AND RSV FOR ABBOTT M2000
- K131862 — 3DVH
- K132304 — EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
- K113806 — KIMGUARD ONE STEP STERILIZATION WRAP
- K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
- K123563 — LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
- K130436 — MULTILINK HYBRID ABUTMENT CEMENT
- K130749 — SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR
- K130960 — SURESUBTRACTION ORTHO
- K131071 — STAXX IBL SYSTEM
- K131129 — CAS PSI SHOULDER
- K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
- K131466 — MAPCHECK2, ARCCHECK
- K131785 — PAGODA PEDICLE SCREW SYSTEM
- K131803 — GUARDIAN URETHRAL SHEATH
- K131842 — STERICAN CANNULA
- K132228 — UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
- K132365 — SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
- K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
- K132263 — AXERA 2 ACCESS SYSTEM
- K121736 — PERF-GEN PULSATILE PERFUSION SOLUTION
- K123582 — ENDO A CLASS
- K123604 — ABG III MONOLITHIC HIP STEM
- K123605 — SMARTFLOW CATHETER
- K123608 — ENDO E CLASS
- K123633 — TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
- K123756 — COVAGEN
- K123830 — INTERMITTENT PNEUMATIC COMPRESSION DEVICE
- K123975 — QUICKIE & ZIPPIE SERIES
- K130160 — VERIFY PROCESS INDICATOR FOR RELIANCE EPS
- K130163 — D-LUX
- K130768 — JIAJIAN CMN STIMULATOR
- K130793 — NEWA SKIN THERAPY SYSTEM
- K131052 — TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
- K131325 — QUATTRO GL SUTURE ANCHOR
- K131634 — SYMBIA
- K131687 — 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
- K131829 — INTELLIVUE PATIENT MONITOR
- K132334 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
- K122181 — EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
- K123766 — NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
- K123988 — ANYONETM INTERNAL IMPLANT SYSTEM
- K130074 — GYMFORM ABS-A-ROUND
- K130299 — GMK HINGE
- K130392 — KINEX BIOACTIVE
- K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
- K130752 — DYNASENSE SYSTEM
- K130779 — LVIVO EF SYSTEM
- K130832 — ORTHOHELIX STAPLE SYSTEM
- K131063 — AMPLATZER TORQ VUE LP DELIVERY SYSTEM
- K131144 — AMECO SHEATH INTRODUCER
- K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
- K131478 — CONTRAST CONSERVATION SYSTEM
- K131570 — ORTHOVISION
- K132072 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
- K132341 — DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
- K123882 — AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
- K130421 — MERON APPLICATION CAPSULES
- K130602 — LASSO NAV DUO LOOP CATHETER
- K130693 — AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
- K130948 — C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
- K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
- K131425 — NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
- K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
- K131870 — GLIDE DEVICE
- K131951 — IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
- K132159 — PROADENO+ ASSAY
- K132200 — PRO HMPV+ ASSAY
- K123061 — ACE MONOPOLAR ATTACHMENT
- K123443 — PRECISE SHP DIODE LASER
- K123473 — HOPER PTCA BALLOON CATHETER
- K123814 — HUMELOCK II CEMENTED SHOULDER SYSTEM
- K123834 — EASYSTAND BANTAM MEDIUM
- K130398 — SOFIA(R) RSV FIA
- K130672 — OPTIFLOW II FLOWABLE COMPOSITE, LC
- K130682 — MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
- K130887 — S4C NAVIGATION INSTRUMENTS
- K130900 — EVICEL APPLICATION DEVICE
- K131464 — EXTRICARE NPWT FOOT DRESSING
- K123699 — FAHL TRACHEOSTOMY TUBES (MULTIPLE)
- K123864 — GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
- K123891 — SPARTAN RX CYP2C19 TEST SYSTEM
- K131014 — PANA SPRAY PLUS
- K131032 — PHILIPS SURESIGNS CENTRAL
- K131133 — VIVORTE BVF LITE
- K131532 — ELECTROMAGNETIC TRANSMITTING STYLET
- K131536 — IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
- K132197 — CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
- K122562 — E-TENG MODEL EOR 1
- K123076 — PROFTHAND MECHANICAL WHEELCHAIR
- K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
- K124014 — SUREFIX INTERSPINOUS FUSION SYSTEM
- K130089 — CROSSTREES PVA POD
- K130484 — MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.