FDA 510(k) clearances — page 551
clearances on record, most recent first.
Clearances — page 551
55,001–55,100 of 176,542- K082406 — EXPANDABLE PEEK-OPTIMA IMPLANT
- K082748 — ATRIUM PROLITE S MESH
- K083025 — SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
- K083149 — ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
- K083769 — MODIFICATION TO URESTA PESSARY
- K083916 — LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
- K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
- K080299 — RESPIFIT S, MODEL RS-LR1001004
- K081230 — TRAUSON INTRAMEDULLARY NAIL
- K082089 — PRUMYX CREAM
- K082488 — DIAZYME LP(A) ASSAY
- K082605 — VPAP AUTO WITH HUMIDAIRE 3I
- K083082 — MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
- K083089 — NEWPORT SPINAL SYSTEM
- K083155 — HD CAMERA HEAD OTV-S7PROH-HD-L08E
- K083166 — SPECIALTY COILS FOR THE MAGNETOM ESSENZA
- K083167 — PHENIX CERVICAL INTERBODY DEVICE
- K083417 — INTRATEMP SOLUTION WARMER
- K083743 — CAPSURE PS SYSTEM
- K083814 — OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
- K083837 — JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
- K083877 — FLYING DIAGNOSTIC ULTRASOUND SYSTEM
- K083907 — MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
- K082231 — ASCENSION SILICONE PIP
- K082622 — ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE
- K082746 — ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
- K082787 — VITAL SIGNS MONITOR, MODEL: MD500B
- K082905 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
- K082936 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K083036 — VOCO PROFLUORID L
- K083145 — ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
- K083162 — STINGRAY ELECTROSURGICAL FORCEPS
- K083240 — OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
- K081767 — AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
- K081956 — MEDINOL X-SUIT NIR BILIARY METALLIC STENT
- K082466 — XYCOR SPINAL IMPLANT
- K082660 — V60 VENTILATOR, MODEL V8000
- K082704 — BIRTHTRACK (A.K.A. CLM)
- K082808 — IMAGESVR PACS
- K082863 — DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
- K082917 — MASTERGRAFT RESORBABLE CERAMIC GRANULES
- K083060 — REPROCESSED HARMONIC SCALPEL
- K083061 — ELLEX INNOVATIVE IMAGING EYE CUBED V4
- K083331 — CONFIDANT, MODEL 2.6
- K083332 — MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
- K083358 — LUBRICANO-ULTRASOUND
- K083416 — REVOLVE STABILIZATION SYSTEM
- K083522 — SONY UP-DF750 DIGITAL FILM IMAGER
- K083664 — FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
- K083682 — 180W CERELAS D 980NM DIODE LASER, MODEL D180
- K083701 — PANASIL INITIAL CONTACT AND PANASIL TRAY
- K083730 — ISOLAZ
- K072882 — PAIN VISION, MODEL PS-2100
- K080431 — RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
- K081703 — MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
- K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
- K083274 — WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
- K083510 — KUBTEC XPERT 20
- K083721 — MODIFICATION TO ZENIEVA
- K071754 — NEO-VAGINA SURGERY SET AND ACCESSORIES
- K073618 — VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
- K080179 — REFLEXION HD HIGH-DENSITY MAPPING CATHETER
- K081924 — CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
- K082598 — POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
- K082789 — G1B PULSE OXIMETER
- K082827 — A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
- K082941 — BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
- K083032 — PERI-LOC BONE PLATING AND SCREW SYSTEM
- K081258 — VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
- K082750 — ENTACT SEPTAL STAPLER, MODEL 610-00100
- K082857 — RENEGADE WHEELCHAIR
- K082943 — IROOT BP, MODEL IRBP 4609
- K083494 — ULTIMA FIVE
- K081815 — VOCALIS GEL
- K081816 — VOCALIS AND VOCALIS SM
- K081877 — ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
- K082473 — BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
- K082526 — CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
- K082291 — A-LAP SET (A-LAP, EZAXESS, TROCAR)
- K082351 — NEPTUNE HYPERBARIC VENTILATOR
- K082396 — DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
- K082712 — THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
- K082968 — APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
- K082979 — S8 ADVANCE
- K082983 — RESSCAN-PRO
- K083646 — MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
- K080455 — RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
- K080740 — CLEARVIEW ENDOSCOPE COVER
- K083452 — ERBE MODEL VIO 300 D WITH ACCESSORIES
- K072964 — NICOLET CORTICAL STIMULATOR
- K082203 — NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021; CSK-022; CSK-023; CSK-025
- K082435 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER
- K082472 — VIROCULT, MODEL MW950
- K082613 — MERIT MICROCATHETER
- K082652 — BITTAR ZIRCONIA BLOCKS
- K082878 — NEVONI CLASSIC, MODEL 6600-PO
- K082999 — ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
- K083213 — SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
- K083673 — CARESTREAM PACS, MODEL CARESTREAM PACS VII
- K083765 — MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.