FDA 510(k) clearances — page 570
clearances on record, most recent first.
Clearances — page 570
56,901–57,000 of 176,542- K080480 — NANOCOMPOSITE RESTORATIVE KIT
- K080588 — SCIENT'X TRIBECA VBR
- K080763 — TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
- K081034 — SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS
- K081035 — AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
- K081069 — GORE INFINIT MESH
- K081252 — EXPEDIUM 4.5MM SPINE SYSTEM
- K072290 — PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
- K073006 — OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
- K073295 — UREA/BUN, SCAL, NORTROL, ABTROL
- K080161 — PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
- K080728 — LDR SPINE ROI-C IMPLANT
- K080860 — CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
- K080951 — 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
- K080952 — 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A
- K081102 — VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
- K081194 — INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
- K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
- K081278 — OMEGA 3 TROCHANTERIC STABILIZING PLATE
- K081359 — GENESIS ECP
- K081416 — PALOMAR ASPIRE LASER PLATFORM
- K073213 — THERABOND ANTIMICROBIAL BARRIER SYSTEMS
- K073244 — VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES
- K073326 — NRG TRANSSEPTAL NEEDLE
- K080424 — HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
- K080551 — UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE
- K080934 — VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
- K081045 — DESTINATION RENAL GUIDING SHEATH
- K081050 — PARIETEX PROGRIP MESH
- K081170 — PROSTATE TISSUE MARKER
- K081195 — REVERE UNIPLANAR SCREWS
- K081201 — WBR XPRESS3.CARDIAC
- K081203 — OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
- K081220 — MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
- K081274 — SURESKIN SILVER BANDAGES
- K081347 — ILUMA VISION
- K081256 — WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
- K081320 — DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
- K071977 — TARRY MEDICAL TEMPERATURE PROBES
- K072399 — DEL SOL RED LIGHT THERAPY SYSTEM
- K072564 — ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
- K072859 — ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
- K072863 — ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
- K073261 — VAR MONITOR
- K073362 — MROPEN
- K073415 — NEMUS SYSTEM; NEMUS PC PERIPHERAL
- K073467 — SPINEASSIST SYSTEM
- K073612 — URIC ACID (AOX), SCAL, NORTROL, ABTROL
- K080020 — ARCOFIX
- K080255 — NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
- K080321 — SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
- K080427 — WATCH-PAT MODEL 100S-2
- K080522 — SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
- K080547 — ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
- K080618 — DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
- K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
- K080842 — APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
- K080869 — ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
- K080937 — POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
- K081074 — DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
- K081103 — LOCI THYROID CALIBRATOR WITH MODEL RC610
- K081154 — ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
- K081169 — AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR
- K081186 — CONCAVE RN HEALING CAP
- K062273 — SPACER-G TEMPORARY HIP PROSTHESIS
- K062274 — SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
- K073684 — SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
- K080159 — KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
- K080257 — MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
- K081217 — HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
- K081291 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
- K070412 — ELEXOMA MEDIC
- K072904 — SONOCA 180/195 WOUND CARE SYSTEM
- K073551 — SMITH & NEPHEW INSTRUMENT TRAYS
- K080479 — DENTAL CERAMIC
- K080598 — MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
- K080699 — NOVEL SPINAL SPACER SYSTEM
- K080767 — CONQUEST SPINAL SYSTEM
- K080839 — ECHELON GRAY CARTRIDGE, MODEL ERC45M
- K081046 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K080403 — XTJF TYPE Q160VF1
- K080946 — CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
- K081009 — NEUTROPHASE
- K081040 — POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
- K081281 — OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
- K071889 — DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
- K072600 — INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
- K080620 — MODIFICATION TO 3M TEGADERM CHG DRESSING
- K072258 — BI-RADS COMPANION
- K072276 — SUBDERMAL NEEDLE ELECTRODES
- K072300 — POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM
- K073070 — DIO BIOTITE-H IMPLANT SYSTEM
- K080029 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM
- K080168 — SHUNTCHECK - CSF SHUNT FLOW DETECTOR
- K080439 — SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
- K080515 — FMRI HARDWARE SYSTEM
- K080578 — DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
- K080713 — REACTIVE DENTAL IMPLANT SYSTEM
- K080954 — T34L SYRINGE DRIVER
- K080994 — AMPLATZER TORQVUE EXCHANGE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.