FDA 510(k) clearances — page 557
clearances on record, most recent first.
Clearances — page 557
55,601–55,700 of 176,542- K082530 — APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
- K082667 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
- K082717 — AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
- K082906 — UNITY BETA ANCHOR SYSTEM
- K083066 — CHROMOPHARE E 778 AND E 558
- K073307 — MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
- K082163 — FLOWMEDICA BENEPHIT INFUSION SYSTEMS
- K082198 — DURASHIELD PLUS
- K082267 — PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
- K082357 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).
- K082847 — PINNACLE ROII INTRODUCER SHEATH
- K083021 — APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- K082183 — PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
- K082209 — DEVILBISS DV5M SMARTLINK SYSTEM
- K082314 — BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
- K082414 — OPTIFLUX F250NR, MODEL 0500325E
- K082595 — MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
- K082721 — LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
- K082722 — P & F POWER WHEELCHAIR, MODEL HC-500SB
- K082798 — DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000
- K082870 — VTI INTRAOPERATIVE DOPPLER SYSTEMS
- K082900 — KYMCO FORU, MODEL EQ10
- K082901 — KYMCO FORU, MODEL EQ20
- K072348 — PRECISION OXYGEN CONCENTRATOR
- K080339 — MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
- K081248 — QUANTA LITE OMP PLUS ELISA
- K081733 — 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
- K081965 — MPOWRX SNORING SOLUTION
- K082164 — PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
- K082464 — PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
- K082536 — COOK WIRE GUIDES
- K082919 — UC-CARE POSITIONING SYSTEM
- K083043 — KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
- K081413 — TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
- K081520 — SENSITITRE VIZION
- K081587 — KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
- K081732 — INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
- K081900 — TEMPORARY TOOTH REPLACEMENT
- K082120 — AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
- K082263 — CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
- K082285 — EASY GLAZE
- K082597 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K082826 — VANGUARD CR STEM HOUSINGS
- K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT
- K082868 — MULLINS-X, MODEL 250X
- K082923 — PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
- K083017 — LEVO C3
- K072603 — ABC SYRINGE INFUSION PUMP, MODEL 4100
- K080003 — BINAXNOW G6PD TEST
- K080944 — X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
- K081352 — PROFILE MULTI-PLATFORM SYSTEM
- K081382 — DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
- K081543 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
- K081650 — AERONEB GO NEBULIZER
- K082139 — EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
- K082298 — FLASH N' GO
- K082493 — MEDICAL DISPLAY, MD205MG-1
- K082820 — K-PACK II NEEDLE - 29G THIN WALL
- K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM
- K082865 — MODIFICATION TO ZENIEVA
- K082969 — LUMINEX INFRARED LAMP SYSTEM
- K081023 — EVOLIS TOTAL KNEE SYSTEM
- K081436 — INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
- K082088 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
- K082221 — RAYDOSE
- K082513 — ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
- K082812 — OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
- K082822 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K083001 — M5 DIAGNOSTIC ULTRASOUND SYSTEM
- K083019 — GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
- K073645 — SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM
- K080466 — ALCOHOL PAD
- K080877 — 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
- K081210 — NIPRO SAFETOUCH HUBER INFUSTION SET
- K081404 — SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
- K081791 — E-Z CLEAN ELECTROSURGICAL ELECTRODE
- K082095 — ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
- K082135 — SHOWCASE
- K082417 — GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
- K082514 — TENS/EMS COMBO, EMS, TENS
- K082532 — STRAUMANN GUIDED INSTRUMENTS
- K082576 — XCHF-T160 VIDEOSCOPE
- K082767 — KOWA NONMYD ALPHA-DIII
- K082768 — G-BOND PLUS
- K082774 — LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
- K080629 — PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
- K080854 — DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
- K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K082174 — Y-ADAPTER
- K082564 — HYPERQ SYSTEM
- K073309 — ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
- K080906 — CDB CLIP
- K080908 — INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
- K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
- K080923 — CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB
- K081127 — ACCIN TOTAL KNEE SYSTEM
- K081348 — TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
- K081408 — ELLIPSE MULTIFLEX
- K081438 — MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
- K081475 — ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
Data sourced from openFDA. This site is unofficial and independent of the FDA.