FDA 510(k) clearances — page 512
clearances on record, most recent first.
Clearances — page 512
51,101–51,200 of 175,825- K093338 — SELF ADHESIVE COMPOSITE LUTING CEMENT
- K093449 — MINI LAP RETRACTORS
- K093631 — B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
- K093696 — SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
- K094019 — GLIDER PTA BALLOON CATHETER
- K100061 — CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
- K100078 — MODIFIED STRAIGHT FIRE LASER FIBER
- K100122 — MODIFICATION TO CAPSURE PS SYSTEM
- K100207 — NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
- K090250 — ELECTRO-LIGHT THERAPY
- K093379 — TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
- K093637 — JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
- K090264 — HEMOSIL D-DIMER HS 500, CONTROLS
- K091210 — ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT
- K091493 — ORTHO SELECT BONE PLATES AND SCREW SYSTEM
- K091757 — OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
- K091769 — TRUST DAM
- K092142 — SPORT-ELEC BODY CONTROL SYSTEM BS
- K093005 — FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
- K093007 — ENTELLUS MEDICAL BALLOON DEVICE
- K093081 — POCKET BVM
- K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
- K093476 — AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120
- K093567 — ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
- K093861 — IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
- K082525 — CORIN METAFIX FEMORAL STEM
- K090609 — OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
- K091077 — OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
- K091363 — COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
- K091522 — IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
- K092527 — NEXUS INJECTION SITE, MODEL NIS-8
- K092531 — SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
- K092574 — ESL SPINAL SYSTEM
- K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
- K092800 — ANTI-WRINKLE (AGING) LIGHT, MODEL AAL
- K092836 — OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141
- K092918 — PARI VIOS
- K093059 — SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
- K093062 — VERTOS MEDICAL MILD DEVICE KIT
- K093142 — TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
- K093444 — EXAPACS
- K093688 — CANON, MODEL URS-50RF
- K093846 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
- K093927 — 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER
- K100044 — FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
- K100070 — UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
- K100192 — STRONG DENTAL HANDPIECES
- K082230 — VECTRA PLUS LASER SYSTEM AND ACCESSORIES
- K083764 — AMPHETAMINES II
- K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
- K092746 — MICRONJET 600
- K093496 — NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT
- K093572 — R650 QDASM COLLIMATOR
- K092774 — ATLAS INTERVERTEBRAL BODY CAGE
- K092970 — GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H
- K093474 — DEPUY FRACTURE AND FUSION PLATING SYSTEM
- K100063 — HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
- K100090 — IMPLANTABLE CLIP
- K100146 — EVOLVE EPS ORTHOLOC
- K082315 — EC50 MICRO+ SMOKERLYZER
- K090111 — FLEXPEN NEEDLE
- K090755 — QUANTA LITE APS/PT IGG AND IGM ELISA
- K092821 — TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021
- K092897 — LAP LOOP
- K093112 — DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
- K093284 — 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
- K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM
- K093563 — IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
- K093727 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR
- K090427 — URSA ANGIOGRAPHIC CATHETER
- K092828 — STATNET, MODEL 3100
- K093416 — TRILOGY 200 VENTILATOR
- K100014 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
- K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL
- K100117 — LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
- K091278 — VALEO SPACER SYSTEM
- K091583 — MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
- K091794 — CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
- K092176 — TAKE 1 ADVANCED RIGID TRAY
- K092508 — FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
- K092589 — THERMOTEX PLATINUM SYSTEM
- K093021 — ATLANTIS SLIT LAMP
- K093143 — MISSION BREATH ALCOHOL DETECTOR
- K093331 — SR PHONARES NHC
- K093386 — CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
- K093433 — VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
- K093560 — UPCERA ZIRCONIA BLANKS
- K093667 — SHOULDER SPEEDER COIL
- K093822 — DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY
- K100067 — MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
- K091428 — EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
- K092540 — C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
- K092846 — AIRVO SERIES HUMIDIFIERS
- K093125 — ALPHAXENON LIGHT 180 W AND 300 W
- K093182 — SET GRI-FILL 3.0
- K093271 — EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD
- K093368 — BUTTERFLY TONER MODEL GYM070
- K093484 — PREMISE FLOWABLE MODIFIED
- K093995 — IG 4 IMAGE GUIDED SYSTEM
- K091949 — MICROSCAN MICROSTREP PLUS, MODEL B1027-201
Data sourced from openFDA. This site is unofficial and independent of the FDA.