FDA 510(k) clearances — page 413
clearances on record, most recent first.
Clearances — page 413
41,201–41,300 of 175,770- K130250 — QYAG LASER SYSTEM
- K130334 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
- K130458 — KNOTLESS FIBERTAK SUTURE ANCHOR
- K130594 — ENSITE VELOCITY SYSTEM
- K130632 — STERISPINE PS PEDICLE SCREW
- K130786 — SLEEK OTW PTA CATHETER
- K120532 — GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
- K122196 — CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
- K122368 — WATERLASE IPLUS ALL TISSUE LASER
- K122388 — SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
- K122525 — SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K123500 — AQUILION LB TRITON V4.91
- K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
- K123971 — CYNOSURE 1064NM DIODE LASER
- K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
- K130174 — DVTCARE CA5
- K130330 — RANGE SPINAL SYSTEM
- K130346 — SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
- K130591 — SUPERA VERITAS
- K130605 — INOMAX DSIR (DELIVERY SYSTEM)
- K130811 — PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
- K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
- K121401 — TENDER TOUCH
- K121613 — AGILIA INFUSION SYSTEM
- K122347 — ELISIO-H AND ELISIO-M HEMODIALYZERS
- K122595 — HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
- K123550 — UTF STEM, REDUCED
- K123636 — H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
- K123932 — ZYGAFIX SPINAL FACET SCREW SYSTEM
- K130169 — FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE
- K130216 — ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
- K130434 — OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
- K130626 — MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
- K130899 — BIOLOX DELTA CERAMIC FEMORAL HEADS
- K130968 — VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
- K120599 — DEPUY M-SPEC 36MM FEMORAL HEADS
- K122664 — ZUGA DENTAL IMPLANT SYSTEM
- K122767 — NMI PORT
- K122888 — CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
- K122905 — PEREGRINE 23GA CURVED LASER PROBE
- K122945 — STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
- K123941 — KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
- K130233 — NEUROSTAR TMS THERAPY SYSTEM
- K130518 — MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
- K130957 — WVSM (WIRLESS VITAL SIGNS MONITOR)
- K123421 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K123470 — PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
- K123482 — REFLOW ASPIRATION CATHETER
- K123601 — SINGLE USE REPOSITIONABLE CLIP
- K130202 — IRIS ANTERIOR CERVICAL PLATE
- K130222 — STRAUMANN DENTAL IMPLANT SYSTEM
- K130406 — DIAGNOSTICPRO EDGE
- K130482 — COMBAT READY CLAMP
- K130762 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
- K113781 — PANTHEON SPINAL IBFD SYSTEM
- K120984 — MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
- K122225 — STERILE RADIOLUCENT SKULL PINS
- K122510 — ICRCO 3600M
- K122549 — DENTO TEMP
- K122908 — PRG BARRIER COAT
- K123271 — ABBOTT PHENOBARBITAL ASSAY
- K123386 — PERIOTYPE X-PERT
- K123755 — MULTI ANGLED ABUTMENT
- K123921 — BODYTRONIC 200
- K123990 — SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
- K130201 — NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
- K130764 — AUDIT MICROCV VITAMIN D LINEARITY SET
- K130876 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET
- K120800 — NVISION VLE IMAGING SYSTEM
- K122703 — RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
- K123028 — VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
- K123128 — SERI SURGICAL SCAFFOLD
- K123282 — DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
- K123527 — AIRLIFE
- K124032 — METANEB
- K130030 — ZAVATION CERVICAL PLATE SYSTEM
- K130445 — VAULT ALIF SYSTEM
- K130860 — VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
- K130886 — GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
- K120989 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
- K122826 — PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM
- K123295 — RHYTHM VIEW
- K123658 — BIOMODULE 3-M1
- K123915 — DE48-PLUS
- K123936 — SURGISEAL TOPICAL SKIN ADHESIVE
- K130896 — VASCULAR PROBE, VASCULAR PROBE ES
- K122051 — NXSTAGE SYSTEM ONE
- K122485 — ENCIRCLE COMPRESSION THERAPY STOCKING
- K123018 — ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
- K123307 — NUVASIVE NVM5 SYSTEM
- K123973 — AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
- K130161 — PASSEO-35
- K130389 — MAYFIELD INFINITY XR2 SKULL CLAMP
- K130643 — ACCELEDENT AURA
- K130741 — ERCHONIA PL5000
- K122146 — XHIBIT CENTRAL STATION, MODEL 96102
- K122167 — NEXXIS OR
- K122381 — NEXFIN MODEL 2
- K123539 — STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
- K130318 — NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
Data sourced from openFDA. This site is unofficial and independent of the FDA.