FDA 510(k) clearances — page 404
clearances on record, most recent first.
Clearances — page 404
40,301–40,400 of 175,770- K132535 — AUTOBAND LIGATOR
- K122100 — POWDERED VINYL EXAMINATION GLOVES
- K122627 — GIO DIGITAL PRESSURE GUAGES
- K130012 — WET PLATINUM PERSONAL LUBRICANT
- K130027 — DISPOSABLE NEUTRAL ELECTRODE GP202
- K130076 — PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
- K130301 — LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
- K130714 — PROGIGY SUPPORT CATHETER
- K130936 — AERODR SYSTEM WITH P-31
- K130951 — SIM
- K131085 — CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
- K131097 — LEGACY3 6MM LENGTH IMPLANTS
- K131126 — OPTI CCA-TS2
- K131310 — GMK FULL PE TIBIAL COMPONENTS
- K131432 — CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL
- K131451 — PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
- K131523 — CRYOBALLOON FOCAL ABLATION SYSTEM
- K131581 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
- K131657 — FLOWER SMALL AND MEDIUM IMPLANT SET
- K131707 — 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
- K131736 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
- K131884 — AVENIR CEMENTED HIP STEM
- K131969 — SYMBOTEX(TM) COMPOSITE MESH
- K132099 — ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
- K132169 — SURGIQUEST AIRSEAL IFS
- K132204 — INSUFLOW SYNERGY XL PORT
- K132332 — MOUNTAINEER OCT SPINAL SYSTEM
- K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.