FDA 510(k) clearances — page 439
clearances on record, most recent first.
Clearances — page 439
43,801–43,900 of 175,770- K120855 — INTELLISPACE ECG
- K120897 — PROGRIP LAPARSCOPIC SELF-FIXATING MESH
- K120963 — POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
- K120990 — NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
- K121092 — FLOWEASE [SUBCUTANEOUS] INFUSION SET
- K121175 — FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
- K121191 — VERTEX RCCONSTRUCTION SYSTEM
- K121288 — FUSE CAGE
- K121330 — WAVE O CAGE
- K121332 — LOOP CAGE
- K121333 — WAVE D CAGE
- K121574 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K121634 — INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
- K121701 — SYSTEMS INTEGRATION
- K103467 — CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
- K113704 — ARCHITECT HAVAB-G
- K120375 — MED-RX PATIENT DELIVERY SET
- K120611 — SONY PVM-2551MD OLED MONITOR
- K120810 — FIBEROPTIC LASER DELIVERY SYSTEM
- K120918 — NUVASIVE COROENT TITANIUM SYSTEM
- K120996 — FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
- K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
- K121527 — WI-FI BODY SCALE
- K112686 — NEXT GEN EMG ENDOTRACHEAL TUBE
- K113326 — ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
- K113835 — DATACAPTOR SYSTEM
- K120243 — GAM-200
- K120371 — DR GREENBURGS HYBRID ACRYLIC
- K120372 — DR GREENBURGS HYBRID VACUUM
- K120760 — LDR SPINE SPINETUNE TL SPINAL SYSTEM
- K120780 — EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
- K121016 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K121049 — UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
- K121211 — VU APOD INTERVERTEBRAL BODY FUSION DEVICE
- K121274 — PIXEL APP
- K121295 — ARTISTETM SOLUTION WITH SYS VCIO
- K121522 — POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
- DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
- K111369 — THE HELENA V8 IMMUNODISPLACEMENT KIT
- K113017 — SYS*STIM 240
- K113383 — XTRAFIX EXTERNAL FIXATION SYSTEM
- K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
- K120025 — SURGIMESH XB - SKIRTED
- K120632 — AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
- K120680 — ENSPIRE DISCECTOMY SYSTEM
- K121681 — GLIDER PTCA BALLOON CATHETER
- K120134 — IPS E.MAX PRESS MULTI
- K120336 — NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
- K121290 — AQUAMANTRYS3 BSC 9.1S
- K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
- K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP
- K112827 — SHEATHES ULTRASOND GEL
- K112975 — CARBONAID C02 DIFFUSER
- K113873 — PENTAX EPK-I5020 VIDEO PROCESSOR
- K120342 — EMG RECORDING ELECTRODE ASSEMBLY
- K120415 — CRYO-TOUCH III
- K120472 — QUANTRA
- K120690 — INSULIN PEN NEEDLE
- K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
- K120975 — CS 8100 CS 8100 ACCESS
- K121018 — BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
- K121222 — TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
- K121342 — XIA 4.5 SPINAL SYSTEM
- K121459 — SYNGO.MR NEUROLOGY
- K121468 — EUROTROL GAS-ISE METABOLITES
- K121532 — HERO GRAFT
- K121577 — APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
- K121646 — ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM
- K121699 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM
- K112824 — QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
- K113277 — ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
- K113566 — OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
- K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
- K120247 — EASYDEX
- K120339 — PROCOLL
- K120524 — SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
- K121028 — ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
- K121031 — WAVELIGHT FS200 PATIENT INTERFACE 1505
- K121032 — PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
- K121165 — BEAM BRUSH/BEAM APP
- K121367 — ZOLL PROPAQ XM
- K121378 — AIRTRAQ SP AIRTRAQ AVANT
- K121521 — AXERA ACCESS SYSTEM
- K121675 — VERSAVIT
- K112024 — TI-MAX X450
- K112809 — BLUE MOUNTAIN CERVICAL PLATE
- K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATOR
- K120048 — DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
- K120418 — ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
- K120447 — X4
- K120567 — GYRUS AMCI PK BUTTON ELECTRODE
- K120702 — E.G. SCAN II ESPHAGOSCOPE SYSTEM
- K120783 — ABLE-X
- K120877 — MICROMANIPULATOR SET
- K120916 — QFIX RADIOTHERAPY CHAIR
- K121403 — CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
- K121493 — ASCEND SHOULDER SYSTEM
- K121530 — BODYFIX SYSTEM
- K121534 — CONE-TROL HEMOGLOBIN A1C CONTROL SET
- K121588 — RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
Data sourced from openFDA. This site is unofficial and independent of the FDA.