FDA 510(k) clearances — page 457
clearances on record, most recent first.
Clearances — page 457
45,601–45,700 of 175,770- K112637 — NETKONNECT REMOTE NETWORK EXTENSION
- K112946 — ACTIV VARNISH
- K113084 — RENOVIS CANNULATED SCREW SYSTEM
- K113300 — ATB ADVANCE PTA DILATATION CATHETER
- K113303 — OSLEOBRIDGE IDSF SPACER CONECTOR
- K113325 — EVOLUTION MP ADAPTIVE CS INSERT
- K113500 — CANADY VIEIRA HYBRID PLASMA SCALPEL
- K093477 — SHIELD KYPHOPLASTY SYSTEM
- K103103 — PRESSON ELECTRODE
- K110068 — MODEL PM3030
- K110325 — AQUA LUBE
- K110379 — AIR-N-GO
- K110926 — BONE PLATE; BONE SCREW
- K111123 — VARILIFT CERVICAL INTERBODY FUSION SYSTEM
- K111310 — BRUX MOUTHGUARDS
- K111646 — ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
- K111651 — SPLIT CATH III
- K111736 — TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
- K111853 — ANGLED TAPERED ABUTMENT
- K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
- K112208 — INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
- K112533 — ZAVATION CERVICAL PLATE SYSTEM
- K112991 — MODIFIED ROG SUTURE ANCHOR
- K113111 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
- K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
- K113309 — EXACTECH EQUINOXE CAGE GLENOIDS
- K103544 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
- K110046 — ATHENA PEDICLE SCREW SYSTEM
- K110364 — DORNIER MEDILAS D LITEBEAM+ 1470
- K110457 — 3M TEGADERM MATRIX DRESSING
- K110698 — NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
- K110924 — DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
- K111483 — JOULE CLEARSENSE LASER SYSTEM
- K112479 — DSJ MASSAGER
- K112489 — SWIFT FX BELLA
- K112597 — SEITY 37% PHOSPHORIC ACID ETCHANT GEL
- K113061 — LARGE/EXTRA LAGRE CONDOM
- K113179 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K113182 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
- K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM
- K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
- K111637 — INFRARED EAR THERMOMETER
- K111834 — DISCO SUBTALAR IMPLANT
- K111889 — ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
- K112485 — H-WAVE
- K112565 — NOVAPORT ONE VASCULAR ACCESS CANNULA
- K113011 — SPARTAN S3 FACET SYSTEM
- K113404 — DENTAL 3D PLANNING SOFTWARE
- K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
- K111732 — AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
- K111811 — BENDINI(TM) SPINAL ROD BENDING SYSTEM
- K112125 — ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
- K112583 — SYNTHES CORTICAL SCREWS
- K112592 — AXLE PEEK INTERSPINOUS FUSION SYSTEM
- K112610 — SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
- K112832 — EYE CARE CURE CONTACT LENS CASE
- K112845 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K113213 — LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
- K113350 — BRIVO NM 615
- K113501 — AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
- K110615 — WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
- K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
- K110786 — ESENSOR WARFARIN SENSITIVITY SALIVA TEST
- K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
- K111907 — DYNAMIC DU SERIES PORTABLE DENTAL UNIT
- K111915 — MAGNESIUM ASSAY
- K111922 — VOCARE MYHEALTH TABLET
- K112003 — VANTAGE TITAN HSR
- K112559 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
- K112779 — APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
- K112930 — MOBILE MIM
- K113143 — IMMULISA SCI-70 ANTIBODY ELISA
- K113235 — PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
- K113245 — AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
- K113267 — BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
- K113428 — ANGIOJET ULTRA DVX THROMBECTOMY SET
- K101257 — ADVANCED TRAUMA DRESSING (ATD)
- K103531 — PRESTIGE 24I; BIOLIS 24I; MGC 240
- K111146 — NEWPORT HT70 VENTILATOR
- K111248 — NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
- K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
- K111458 — GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
- K112082 — GUIDELINER V2 CATHETER
- K112095 — ACCULIF TL-PEEK IBF CAGE
- K112126 — GENUINE FIRST AID CPR MASK
- K112138 — ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
- K112181 — HYDROCOIL(R) EMBOLIC SYSTEM (HES)
- K112296 — LATERAL BUTTON
- K112337 — RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
- K112782 — MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
- K112806 — JENSEN ZIRCONIA
- K112813 — AMSCO V-PRO
- K112979 — ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
- K113032 — SNAP WOUND CARE SYSTEM
- K113201 — NARVAL CC
- K113228 — RENAISSANCE SYSTEM
- K103418 — DESARA MINI
- K110106 — VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
- K110424 — DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
- K111655 — FLAATZ 760
Data sourced from openFDA. This site is unofficial and independent of the FDA.