FDA 510(k) clearances — page 387
clearances on record, most recent first.
Clearances — page 387
38,601–38,700 of 176,542- K132956 — U FIT DENTAL IMPLANT SYSTEM
- K140189 — ENDOWRIST VESSEL SEALER
- K140422 — HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
- K140434 — MEDICAD CLASSIC
- K140481 — COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
- K140564 — BN LUMBAR CAGE SYSTEM
- K140602 — FLASH PENTA MB QUICK, FLASH MB QUICK
- K140868 — STRYKER KWIC NEEDLE
- K140924 — STARCERAM
- K141006 — RSP HUMERAL SOCKET INSERT
- K141261 — LOGIQ S7 EXPERT, LOGIQ S7 PRO
- K123126 — MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
- K132143 — EXHALATION VALVE
- K132585 — ZIBONE CERAMIC DENTAL IMPLANT SYSTEM
- K132670 — PANPAC INFLATABLE DOCUT PESSARY
- K132946 — SOFTECH PLUS ETC02 CANNULA
- K133850 — CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
- K133868 — ASTRAL VENTILATOR
- K140802 — STERISPINE PS
- K141323 — VTI SUCTION IRRIGATION SYSTEM
- K123795 — AXON-BUS PROSTHETIC SYSTEM
- K131183 — MED-RX ORAL/ENTERAL SYRINGE
- K132557 — EWNL SAFETY SYRINGE WITH NEEDLE
- K133349 — SMR TT METAL BACK GLENOID
- K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
- K140226 — OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
- K140683 — 0180 INTUITION, 0072 PRECISION
- K140891 — BIOMET CANNULATED SCREW SYSTEM
- K141147 — RANGE SPINAL SYSTEM
- K132016 — LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
- K133478 — POWDER FREE POLYETHYLENE EXAMINATION GLOVES
- K133556 — VIRAGE OCT SPINAL FIXATION SYSTEM
- K133633 — CHOCOLATE PTCA BOLLOON CATHETER
- K133682 — SCHOELLY ARTHROSCOPE
- K133872 — ARIA WIFI SMART SCALE
- K140234 — ASPIRON ACP SYSTEM
- K140337 — BRIGHTMATTER PLANNING SOFTWARE
- K140358 — COMPRESSYN STAPLE
- K140364 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
- K140468 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
- K140774 — TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
- K123940 — DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
- K130304 — LMA FAMILY OF AIRWAYS
- K131319 — T1/T2/T3 TURBINE FAMILY
- K131712 — A-TONE IPL SYSTEM
- K132173 — FAMILY HEALTHWARE
- K132378 — X-MIND UNITY
- K132730 — BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE
- K133123 — NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
- K133198 — ULTRAPRO COMFORT PLUG
- K133328 — AERO-AL LUMBAR CAGE SYSTEM
- K133779 — CP RELIEF WAND
- K133859 — WATCH-PAT200U (WP200U)
- K140211 — ULTRASONIC MESH NEBULIZER
- K140428 — ULTRASOUND SCANNER SYSTEM BK2300
- K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
- K140594 — BODY FAT ANALYZER AND SCALE
- K140676 — PROFEMUR TL CLASSIC LONG NECK HIP STEMS
- K140773 — TERASON USMART3300 ULTRASOUND SYSTEM
- K140787 — PLS (POSTERIOR LUMBAR SYSTEM)
- K140875 — OPTOSSOL COMPRESSION DEVICE SYSTEM
- K141124 — SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
- K141138 — SURFLASH SAFETY I.V. CATHETER
- DEN140002 — EUROIMMUN ANTI-PLA2R IFA
- K131304 — SENTIO MMG
- K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
- K131954 — MEDI PEN NEEDLE
- K132506 — SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
- K132852 — PEEK CAGE FOR THE VERTEBRAL SPINE
- K140049 — MOVES SLC
- K140158 — S.E.A.L. FRACTURE FUSION TUBE
- K140163 — KOALA TOCO
- K140190 — NIGHT SHIFT
- K140326 — XGEO GF50
- K140555 — JOURNEY II BCS CONSTRAINED INSERTS
- K140565 — VARIAX 2 COMPRESSION PLATING SYSTEM
- K140822 — DRIVE RAIL SYSTEM
- K130017 — VALENTINE STEEL WHEELCHAIR
- K131781 — CLEARVIEW TOTAL
- K132416 — REHASTIM 2, ERIGOPRO (FES)
- K132801 — IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
- K133071 — ELASTIC IMPRESSION MATERIAL
- K133316 — SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
- K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
- K133776 — A-DEC/W&H ELECTRIC HANDPIECE MOTOR
- K133953 — LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
- K133956 — NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
- K140127 — FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
- K140139 — CLEARVIEWHD
- K140332 — XGEO GU60A
- K140334 — XGEO GC80
- K140509 — BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
- K140707 — LIFEBORNE INFANT RESUSCITATOR
- K141091 — RAYSERT PLUS INJECTOR
- K132744 — ACESSA GUIDANCE SYSTEM
- K140038 — DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
- K140423 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K140709 — SKYHAWK INTERBODY FUSION SYSTEM
- K123099 — Best-AV2 Pro-Sport(tm)
- K132684 — MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
Data sourced from openFDA. This site is unofficial and independent of the FDA.