FDA 510(k) clearances — page 518
clearances on record, most recent first.
Clearances — page 518
51,701–51,800 of 176,542- K093719 — PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
- K100079 — DIGITAL ULTRASOUND SCANNER
- K100386 — DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
- K083876 — SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT
- K091188 — ASAHI ZENYTEEX GUIDING CATHETER
- K092733 — PYTON
- K092947 — TELESENTRY, MODEL TS01
- K092965 — TRAILRUNNER GUIDEWIRES
- K093174 — SPIROPALM
- K093203 — CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
- K093209 — FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
- K093463 — AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
- K093684 — EASYCARE ONLINE
- K093796 — ASEPT PERITONEAL DRAINAGE SYSTEM
- K100074 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K100075 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
- K100282 — TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
- K091006 — ITG VASCULAR ACCESS SYSTEM, MODEL 300
- K093015 — BINDER INTERVERTEBRAL BODY FUSION DEVICE
- K093592 — ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
- K093741 — SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
- K093942 — ENSITE VELOCITY SYSTEM V1.3
- K100125 — VISION SCIENCES FLEXIBLE ENT SCOPE
- K090068 — STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS
- K091298 — LUBREASE FEMALE LUBRICANT
- K091612 — UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST
- K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
- K091880 — CLAYTON INTRA-AURAL DEVICE (CID)
- K092369 — 12SL ECG ANALYSIS PROGRAM
- K092894 — EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
- K093026 — FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
- K093181 — GYRUS ACMI PK BUTTON ELECTRODE
- K093409 — POWERPUMP ARTHROSCOPY SYSTEM
- K093425 — MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
- K093475 — BASESENS BLOOD GLUCOSE MONITORING SYSTEM
- K093647 — TRAXCESS DOCKING WIRE
- K093748 — DD BIO Z AND DD BIO Z - TRANSPA
- K093751 — CL-DC20, CL-DC21
- K100228 — VERSAPULSE MODEL P20 LASER SYSTEM
- K100267 — FLEXIMARC, MODEL CM-0.9-2-10-GG-L
- K091496 — MEP-90 HAIR GROWTH STIMULATION SYSTEM
- K091860 — AESKULISA MPO, MODEL 30-7303US
- K092580 — TIDI FACEMASK
- K092681 — POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
- K092712 — SKIN BARRIER FILM
- K093086 — ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080
- K093621 — SYNGO.PET&CT ONCOLOGY
- K093653 — URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
- K093797 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE)
- K093798 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE
- K100092 — CORVUS RADIATION THERAPY PLANNING SYSTEM
- K100107 — SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
- K100227 — SAS FLUALERT A&B, SAS INFLUENZA A TEST
- K090019 — NATUS NEUROWORKS, MODEL 104196
- K091283 — CAPILLARYS NEONAT HB (PN 2006)
- K091806 — POGO SCREW INSTRUMENTATION TRAY
- K092144 — BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
- K093426 — BACT-TRAP HEPA MIDI
- K093718 — ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
- K093726 — MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K100380 — ALTERA NEBULIZER SYSTEM, MODEL 678G1002
- K090917 — SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
- K091951 — HAMMERLOCK
- K092295 — PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
- K093318 — ACCELERATOR APS
- K093339 — ELI PC ELECTROCARDIOGRAPH
- K093712 — FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
- K093721 — COSP2
- K093759 — MULTIPLE NAME MODEL MULTIPLE
- K093789 — INTOUCH DIABETES
- K093804 — NUVASIVE HELIX REVOLUTION ACP SYSTEM
- K093805 — OSCAR 3
- K100197 — GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
- K100204 — SONALIS
- K100209 — BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
- K083460 — DIALOG WITH ADIMEA OPTION
- K091029 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
- K091678 — HG II SHORT FIXTURE SYSTEM
- K093447 — CARRIGEN
- K093635 — MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
- K093793 — LS-40 CO2 LASER SYSTEM MODEL LS-40
- K100169 — DURASPAN HEMODIALYSIS LONG-TERM CATHETER
- K092028 — PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
- K092175 — THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
- K092227 — JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
- K092590 — PDS PLATES
- K093064 — TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
- K093120 — XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170
- K093188 — AFM ULTRA AG DRESSINGS
- K093294 — REVERE STABILIZATION SYSTEM
- K093470 — CORE-FLO D/C
- K093533 — ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
- K093650 — BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
- K093711 — RACEGEL
- K093865 — SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
- K093900 — EDGELOCK
- K100138 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K100218 — BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
- K100242 — AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
- K100251 — G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
Data sourced from openFDA. This site is unofficial and independent of the FDA.