FDA 510(k) clearances — page 572
clearances on record, most recent first.
Clearances — page 572
57,101–57,200 of 176,542- K070104 — PROLYTE ELECTROLYTE ANALYZER
- K070463 — REVERA WOUND CARE, MODEL MDW0060
- K072236 — DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
- K072536 — ESA BIOSCIENCES INC. VITAMIN D HPLC TEST
- K073592 — OPTISTAR ELITE INJECTION SYSTEM
- K080569 — LDR SPINE ROI-T IMPLANT
- K080648 — TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
- K080824 — BIO-CONSOLE 560
- K080988 — SCOUTPRO CS LEAD INTRODUCER SYSTEM
- K081082 — U-CLIP UNI-FIRE, MODEL M65
- K072259 — OPHTHALMOSCOPE F-10
- K073493 — HEPATOSTAT SET
- K080009 — NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
- K080050 — SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
- K080397 — AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM
- K080586 — OLYMPUS XCHF TYPE B180Y1
- K080590 — AOS PROXIMAL HUMERAL PLATE
- K080712 — SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
- K080764 — SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
- K080980 — EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
- K081007 — ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
- K073454 — FINGERTIP PULSE OXIMETER, MODEL CMS-50C
- K080509 — CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
- K080605 — SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
- K080898 — AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
- K081031 — ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
- K081066 — BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
- K081181 — SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
- K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
- K071642 — MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
- K072696 — ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
- K073192 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K073281 — CAIS STAPLE
- K073543 — OEC 9900 ELITE
- K080065 — OSFERION
- K080093 — PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
- K080118 — ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
- K080158 — LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
- K080383 — AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
- K080556 — ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
- K080645 — STD MED PRIMO PORT POLY
- K080646 — C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
- K080887 — SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
- K080911 — VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
- K080963 — DSS STABILIZATION SYSTEM
- K080967 — TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
- K080981 — EAR THERMOMETER, MODELS ST66 AND ST67
- K080989 — UNIVERSAL VIAL ACCESS SPIKE
- K081004 — PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
- K081005 — P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
- K081030 — MODIFICATION TO PROFLU+ ASSAY
- K081079 — CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
- K081104 — AESKULISA ANA HEP-2, REF 30-7115US
- K081109 — CORONIS 5MP MAMMO SL, MODEL MDMG 6121
- K081118 — NORAS MR-BI320-PA 1.5T
- K081143 — BIOMERS TRANSLUCENT ORTHODONTIC WIRE
- K081185 — MOBLVAC W.C.
- K071442 — SUPRASORB A +AG
- K071983 — AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
- K073532 — DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
- K080281 — PATHWAY
- K080307 — PROCHEM INDICATOR TAPE
- K080568 — X-MESH EXPANDABLE CAGE SYSTEM
- K081071 — SYNTHES 6.5MM MIDFOOT FUSION BOLT
- K081093 — 3-D IMAGING WORKSTATION
- K081120 — FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS
- K072408 — EMU-GRAPH EMULATOR, MODEL CI 131
- K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
- K073471 — VANTAGECATH INTRAVASCULAR CATHETER
- K073614 — WG-SURGICAL SUTURES WITH NEEDLE
- K080085 — MAS TOX CONTROL
- K080201 — VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
- K080239 — P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
- K080331 — SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
- K080392 — EndoWave Infusion System
- K080396 — OSSEOSPEED NARROW
- K080418 — REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
- K080429 — MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
- K080520 — NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
- K080791 — CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
- K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
- K080845 — ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
- K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
- K080928 — XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
- K072379 — MPS OXIPORT AND MPS OXIPORT PLUS
- K080317 — ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
- K080621 — FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
- K080790 — MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
- K080871 — TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
- K080889 — KODAK 9000C EXTRAORAL IMAGING SYSTEM
- K080890 — SMARTSPOT PRIMAX
- K080968 — S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
- K081047 — TRANSPOSAL ULTRA SYSTEMS
- K081135 — GEMINI CONDOR
- K071867 — RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
- K073168 — AESCULAP PRIMELINE CONTAINER LTD.
- K073643 — TRANS1 AXIALIF 2-LEVEL OR II SYSTEM
- K080195 — NACERA Z AND NACERA Z MEDIUM
- K080329 — CAP PLUS, EQUIVABONE, CAP/DBM
- K080885 — MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
Data sourced from openFDA. This site is unofficial and independent of the FDA.