FDA 510(k) clearances — page 1046
clearances on record, most recent first.
Clearances — page 1046
104,501–104,600 of 175,890- K950442 — INFRARED EXPOSURE HAND SWITCH
- K950458 — SILVER ULTRA MINI CANAL
- K950571 — LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270
- K950691 — MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
- K950692 — MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
- K950693 — MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
- K950694 — COMPACT-X
- K950743 — ORAL PROCEDURE PACK
- K950759 — UNITRON MODEL ESTEEM
- K950773 — PROPHYLAXIS PACK
- K950894 — SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
- K950965 — KARL STORZ STENT APPLICATOR FORCEPS
- K951045 — LASER GAS MIXTURE
- K951075 — S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
- K951111 — RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
- K932769 — CAMINO VENTRICULAR DRAINAGE SYSTEM
- K934178 — ACCUSCREEN 17-HYDROXYPROGESTERONE
- K935449 — FOUNDATION NON-POROUS STEM
- K942091 — OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
- K945211 — KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
- K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
- K950016 — CART, MODE NUMBER UDS-CART
- K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
- K950400 — HAND MASSAGE UNIT
- K950496 — SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
- K950590 — REP CHOLESTEROL PROFILE CONTROL
- K950801 — CARDIO REP LD CONTROL - CAT NO. 3325
- K950902 — ALKO TONOMETERED SALINE CONTROL
- K931133 — CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP
- K936047 — SPECTRUM(TM) MASK
- K943603 — AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
- K944158 — STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT
- K944824 — SUREWING
- K944968 — LANDMARK MIDLINE CATHETER
- K945616 — CORDIS AVANTI CATHETER SHEATH INTRODUCER
- K945720 — JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
- K945977 — CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING
- K946338 — CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
- K950277 — INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER
- K950414 — HEMAGEN ENA SM/RMP KIT (EIA METHOD)
- K950434 — KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
- K950491 — RICH-MAR CARBON ELECTRODES
- K950581 — SMART ANESTHESIA MULTI-GAS (SAM) MODULE
- K950737 — LANDMARK MIDLINE CATHETER
- K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE
- K924997 — EDD
- K932866 — RESOLUT REGENERATIVE MATERIAL
- K942483 — CLINICAL GLASS THERMOMETER
- K942931 — STATLOCK SECUREMENT DEVICES
- K944313 — SPECTACLE FRAME
- K944765 — KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
- K945656 — THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
- K946328 — TDX(R)/TDXFLX(R) PHENYTOIN II
- K950083 — MULTIPLE
- K950165 — INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
- K950789 — STREAK RETINOSCOPE RX-1
- K950791 — STREAK RETINOSCOPE RX-3
- K950792 — STREAK RETINOSCOPE RX-3A
- K950793 — SPOT RETINOSCOPE RX-3SP
- K950794 — STREAK RETINOSCOPE RX-RC
- K950795 — STREAK RETINOSCOPE RX-RP
- K950797 — HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
- K950811 — KARL STORZ FIBER OPTIC LIGH CABLES
- K941596 — REMEDI HS DRUG PROFILING SYSTEM
- K941675 — TDP THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
- K950707 — N LATEX FERRITIN
- K950900 — OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
- K935192 — EMIT IIC CALIBRATORS
- K935982 — SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
- K940028 — ENDOSCOPE SHEATH
- K942096 — TOA MEDICAL ELECTRONICS CA-1000
- K942097 — TOA MEDICAL ELECTRONICS CA-5000
- K942455 — LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- K942622 — LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM
- K942648 — IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
- K942796 — PRESSSION S III
- K943153 — MICROSAMPLE COAGULATION ANALYZER
- K943720 — ITI TRANSVERSAL SCREWING SYSTEM
- K943842 — PULSE OXIMETER MODEL 305
- K944115 — HEPARIN ASSAY CARTRIDGES AND CONTROLS
- K944768 — OLYMPUS INORGANIC PHOSPHORUS REAGENT
- K944936 — MITEK G III ANCHOR, MITEK LS ANCHOR
- K945005 — PANOPLEX HYDROGEL WOUND DRESSING
- K946078 — HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT
- K946377 — ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES
- K946386 — CANDELA RUBY LAZE Q-SWITCHED RUBY LASER
- K950065 — CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
- K950187 — FUTURA ONE
- K950200 — IVID
- K950313 — KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER
- K950344 — HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER
- K950350 — THEMALATOR. MODELS T-4-S, T-8-S, ETC.
- K950351 — CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)
- K950412 — CURAGEL HYDROGEL WOUND DRESSING
- K950459 — GOLD K AMP ULTRA MINI CANAL
- K950460 — GOLD CD ULTRA MINI CANAL
- K950631 — ID400 SERIES ARMBOARDS
- K950701 — WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER
- K950836 — REDFIELD INFRARED COAGULATOR
- K950964 — KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.