FDA 510(k) clearances — page 505
clearances on record, most recent first.
Clearances — page 505
50,401–50,500 of 176,542- K101479 — WINGMAN EXTENDABLE TIP SUPPORT CATHETER
- K101658 — WATERLASE MD TURBO PLUS MODEL 7200XXX
- K101660 — ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
- K101677 — HOSPIRA INFUSION BLOOD SETS
- K101937 — HYBRID TROCAR SYSTEM
- K102025 — COMBAT READY CLAMP
- K102128 — VITABLOCS
- K093771 — QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
- K093999 — ARP POV SPORT
- K100693 — AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
- K100743 — ATLAS SPINE PIVOTING SYSTEM
- K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM
- K101372 — DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
- K101666 — SYNGO. PLAZA VA20A
- K101691 — LIFELINES PHOTIC STIMULATOR
- K101751 — VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
- K101960 — SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
- K091090 — DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
- K100887 — VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY
- K100918 — VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
- K101000 — WELLMIEN SURGICAL MASK
- K101122 — BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
- K101134 — VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
- K101452 — CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
- K102005 — ALLURA XPER OR TABLE SERIES
- K101212 — MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
- K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
- K092686 — ABL90 FLEX SERIES
- K093879 — MISSION SALIVA ALCOHOL TEST STRIP
- K093920 — BUSSE EPIDURAL CATHETER KIT
- K094021 — ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
- K100376 — EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0
- K100935 — LANX SPINAL FIXATION SYSTEM
- K100963 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K101141 — SEILER COLPOSCOPE, MODELS 935, 955 AND 985
- K101508 — MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
- K101542 — HEADWAY 17 ADVANCED MICROCATHETER
- K101591 — STINGRAY ORIENTING BALLOON CATHETER
- K101595 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
- K101647 — WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
- K101877 — OCCLUSION BALLOON CATHETER MODEL OBC
- K101915 — VASOPRESS SUPREME MINI MODEL VP500DM
- K102001 — MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
- K102022 — WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
- K102065 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
- K102081 — ENDOSCOPIC CLIP SYSTEM
- K102117 — TISSU TRANS FILTRON SYRINGE FILL
- K093322 — MULTI-PURPOSE HEALTH DEVICE
- K093868 — I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
- K100382 — SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
- K100820 — WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM
- K100952 — MODIFICATION TO SYNTHES MATRIX SYSTEM
- K101298 — ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
- K091529 — ICAD VERALOOK CTC CAD SOFTWARE
- K093206 — ORTHOMAP 3D 1.1 MODULE
- K100879 — CONTRALCO
- K101198 — CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
- K101279 — CORRIDOR4DM V2010 MODEL: V2010
- K101361 — REEFLEX PTA CATHETER
- K101391 — SCANDIA-45 GAMMA CAMERA SYSTEM
- K101503 — DUSIMETRY CHECK
- K101747 — BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE
- K102028 — NEOTRACT ANCHOR SYSTEM MODEL TAS400
- K092721 — ALIGN RADIAL HEAD SYSTEM
- K092892 — 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
- K100288 — NEOMED ENTERAL ONLY EXTENSION SET
- K100776 — SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
- K100966 — COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
- K101180 — GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
- K101289 — SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
- K101387 — DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
- K091303 — LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
- K092937 — STA-HYBRID HEP CALIBRATOR
- K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
- K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
- K100502 — ASCENSION TOTAL PLATE SYSTEM
- K100556 — SLENDERTONE FLEX MAX, MODEL 517 US
- K100741 — REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012
- K100819 — THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
- K100851 — RANGE SPINAL SYSTEM
- K100946 — INTRAVSCULAR ADMINISTRATION SET
- K101207 — NEODENT IMPLANT SYSTEM
- K101409 — SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
- K101653 — MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
- K101909 — EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
- K101981 — OPTETRAK LOGIC COMBINATION TIBIAL TRAY
- K091018 — ARTHREX BIOWIRE
- K093000 — EMS PIEZON MASTER 700
- K101010 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008
- K101281 — VEGA KNEE SYSTEM
- K101296 — ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
- K101386 — VIGILANT EEG MONITOR MODEL VIGILANT 2.0
- K101423 — OPTIBOND XTR
- K101507 — AMIGO CLASSIC FD
- K093342 — BIOGENNIX RPC
- K093489 — IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY
- K093608 — GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
- K093724 — FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
- K100654 — ZOLL PROPAQ MD
- K100889 — ENDOSKELETON TC
Data sourced from openFDA. This site is unofficial and independent of the FDA.