FDA 510(k) clearances — page 582
clearances on record, most recent first.
Clearances — page 582
58,101–58,200 of 176,542- K073505 — MODIFICATION TO VALEO VBR
- K073687 — HABIB LAPAROSCOPIC HEXABLATE
- K072067 — N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
- K072581 — PM-60 PULSE OXIMETER
- K072121 — TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER
- K072292 — NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS
- K072331 — RADIANCY MISTRAL DEVICE
- K072575 — TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
- K072953 — REDLINE ALCOHOL BREATH TESTER
- K073218 — MTA ADVANCED MATERIAL
- K073306 — XORANCONNECT
- K073481 — THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
- K073535 — BIOFOAM BONE WEDGE
- K070605 — JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
- K070665 — LITHOSKOP
- K071554 — VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
- K071736 — AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
- K072590 — INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM
- K072615 — TXCONTROL
- K072684 — MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
- K072745 — Y-GLIDE
- K072913 — SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
- K073029 — PROFLU+ ASSAY
- K073094 — VITALLINK3 MOBILE VITAL SIGNS SYSTEM
- K073167 — BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
- K073336 — CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
- K073480 — LIFE SPINE CROSS CONNECTOR
- DEN070013 — ID-TAG RESPIRATORY VIRAL PANEL
- K072395 — DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
- K072469 — DIGIFLO CONCENTRATOR ANALYZER
- K072914 — NATURAL BRIDGE LP TRANSVERSE CONNECTORS
- K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
- K073105 — PEEK SPINAL SPHERES
- K073113 — INFINITY PICCO POD, MODEL MS16734
- K073238 — SYNGO VOLUME PERFUSION-CT NEURO
- K073242 — PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400
- K073517 — H-LINK INTEGRATED ROD
- K072751 — COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
- K073313 — MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
- K070789 — EUROIMMUN ANTI-CCP ELISA
- K071695 — KENSEY NASH MACROPORE SHIELD
- K063716 — AEROSOL SYSTEM
- K070357 — FLEXCATH STEERABLE SHEATH & DILATOR
- K070857 — NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
- K071671 — SCANSCOPE XT SYSTEM
- K071905 — POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
- K072105 — ALARIS SYSTEM WITH MMS, MODEL 8XXX
- K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
- K072570 — NOBELACTIVE MULTI UNIT ABUTMENT
- K072718 — PENUMBRA SYSTEM
- K072813 — EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)
- K072937 — OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
- K073221 — CADENCE II
- K073378 — ADVANCE 18LP PTA DILATATION CATHETER
- K073436 — SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM
- K070012 — POLYBONE
- K071886 — SELF SEAL STERILIZATION POUCH
- K072159 — SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER
- K072484 — CYNOSURE YAG FAMILY LASER
- K072485 — ARTISTE MV SA
- K072836 — CHOLESTRAK HDL CHOLESTEROL HOME TEST
- K072996 — REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
- K073178 — HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
- K073237 — REHASTIM & REHAMOVE
- K073367 — HEMOSIL FIBRINOGEN-C
- K072231 — THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)
- K072261 — FINESSE SYSTEM
- K072788 — STORZ MODULITH LITHOTRIPTER SLX-F2-F180
- K072791 — ORACLE SPACER, OPAL SPACER
- K072979 — SPIROBANK G
- K073066 — 308 DERMATOLOGICAL EXCIMER SYSTEM
- K073348 — LUCENT MAGNUM
- K043617 — IMAGECHECKER CT CAD SOFTWARE SYSTEM
- K062580 — GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
- K063304 — LIFE4C
- K070458 — MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
- K070486 — CAPILLARYS URINE (PN 2012)
- K071375 — MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
- K072068 — BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS
- K072138 — VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
- K072328 — MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT
- K072407 — BODYFORM THORACIC FIXATION SYSTEM
- K072475 — BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
- K072640 — IRISPEC,CA/CB/CC
- K072784 — PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
- K072886 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
- K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
- K073199 — 3M ESPE LAVA CHAIRSIDE ORAL SCANNER
- K073399 — TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
- K063686 — DEPUY LPS DISTAL FEMORAL COMPONENT
- K071026 — BD GENEOHM STAPHSR ASSAY
- K071063 — LINASYS
- K071187 — MICROFUSE BONE VOID FILLER
- K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
- K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
- K071730 — STUDIODOP VICORDER
- K071818 — ENSITE FUSION DYNAMIC REGISTRATION TOOL
- K071885 — ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
- K072273 — BELMONT QUOLIS 5000 SERIES DENTAL UNIT
- K072518 — CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.