FDA 510(k) clearances — page 497
clearances on record, most recent first.
Clearances — page 497
49,601–49,700 of 175,770- K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
- K093553 — POSTURETEK
- K100098 — PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
- K100143 — PILOT DIODE LASER, MODEL 002-00139
- K100179 — SPAPLUS
- K100786 — MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
- K101150 — PICC WAND PEELABLE SAFETY INTRODUCER
- K101390 — FASTPACK TSH IMMUNOASSAY
- K101623 — INQUIRY AFOCUSII DIAGNOSTIC CATHETER
- K102037 — AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
- K102149 — GAUNYING INFRARED LAMP
- K091692 — AESCULAP PEEK CRANIOFIX
- K093828 — KYPH X HV-R BONE CEMENT
- K100389 — HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
- K100551 — ORLOCATE SYSTEM MODEL ORL 100
- K100970 — STAINLESS STEEL SPINAL SYSTEM
- K100977 — PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
- K100978 — POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
- K101051 — AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
- K101757 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM
- K101967 — NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'
- K102113 — GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
- K091310 — ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682
- K093304 — PROTEKTOR 32
- K093692 — QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
- K100156 — COLLAGEN DENTAL MEMBRANE V
- K100865 — AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
- K101052 — OMNI III PATIENT MONITOR
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.