FDA 510(k) clearances — page 668
clearances on record, most recent first.
Clearances — page 668
66,701–66,800 of 175,825- K043524 — ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
- K043557 — MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
- K050034 — SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
- K034026 — RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
- K042217 — FLOWMEDIC, MODEL 220
- K042861 — ODYSSEY
- K042896 — SMITH & NEPHEW HYBRID KNEE FEMORAL
- K042993 — TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
- K043009 — BRAINET KIT
- K043129 — PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)
- K043262 — GE SIGNA EXCITE MR SURGICAL OPTION
- K043395 — SMITH & NEPHEW VIDEOARTHROSCOPE
- K043422 — ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
- K043427 — DURAGEN II DURAL REGENERATION MATRIX
- K043429 — CYNERGY LASER
- K043437 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
- K043468 — WILLI GELLER CREATION II PORCELAIN
- K043473 — MODIFICATION TO XIA SPINAL SYSTEM
- K043559 — SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
- K042528 — INBODY, MODEL 3.0
- K042870 — ENDO TWINN
- K043194 — VOXAR 3D PRODUCT FAMILY
- K043201 — WILLI GELLER CREATION ZI PORCELAIN
- K043456 — MODIFICATION TO SOAKER CATHETER
- K043462 — CZR PRESS LF
- K043563 — DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K042184 — GOODKNIGHT H20, MODEL M-114600-00
- K042542 — CYTOVISION FOR CEP XY
- K042624 — AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- K042635 — DENALI SPINE SYSTEM
- K042657 — VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
- K043043 — HERMES BOND 2
- K043305 — ONLINE DAT PHENCYCLIDINE PLUS
- K043354 — MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
- K043376 — HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR
- K043576 — ROCHE AMPLICHIP CYP450 TEST
- K033856 — 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
- K040432 — SOLAR 2 ANATOMIC SHOULDER
- K040887 — B-R-A-H-M-S PCT LIA
- K041824 — X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
- K041917 — PLASIATEK ACTUATOR
- K042117 — PROXIS SYSTEM, MODEL EPS 101
- K042330 — ACETAMINOPHEN-SL ASSAY
- K042641 — CHEMVIEW-10
- K043020 — GLAXY 3.2 SPINAL SYSTEM
- K043028 — EMIT II PLUS ECSTASY ASSAY
- K043045 — SYNTHES (USA) CHRONOS
- K043047 — DYNATRON IBOX IONTOPHORESIS DEVICE
- K043172 — TRUGRAFT BGS SYRINGE, MODEL 600-041
- K043205 — RUSCH EASY TUBE
- K043208 — LIQUID ASSAYED MULTIQUAL CONTROL
- K043347 — BF+
- K043359 — 4100 PATIENT OXIMETER MODULE
- K043477 — POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K043544 — MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
- K043566 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K042316 — VANGUARD REPROCESSED PULSE OXIMETER SENSORS
- K042479 — VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE
- K042483 — INVACARE PRO, COMPACT AND PORTABLE DESKTOP
- K042814 — READMYHEART
- K042827 — CARDIOFAX CE, MODEL PEA-1110K
- K042864 — IMPLANT SCIENCES CORP, MODEL HDR-4140
- K042868 — MAMMOREPORT SOFTCOPY WORKSTATION
- K042938 — GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
- K043136 — ELITY 70 X-RAY
- K043216 — CADSTREAM VERSION 4.0
- K043348 — MODIFICATION TO PM-8000 PATIENT MONITOR
- K043535 — HD11 DIAGNOSTIC ULTRASOUND SYSTEM
- K043088 — MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
- K043273 — LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
- K043295 — VERSYO.DIRECT
- K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
- K043360 — IMT.LAB
- K043552 — VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
- K042432 — PHARMGUARD TOOLBOX, MODEL G6000782
- K043127 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
- K043146 — HORIZON MEDICAL IMAGING
- K042546 — FUNHALER, MODEL FH 101
- K042678 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
- K042792 — IXL-II DIABETES MANAGEMENT SYSTEM
- K043302 — NOVA-PULSE
- K043562 — BC PLUS
- K033210 — BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
- K041125 — MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
- K042221 — CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K043230 — VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
- K030526 — PEDIGUARD NERVE DETECTOR SYSTEM
- K041407 — TITANIUM MESH IMPLANT
- K041652 — ACUPUNCTURE NEEDLES
- K042414 — VISIOPLAST ACRYLIC RESIN
- K042705 — DISPOSABLE NON-ADHESIVE SPO2 SENSORS
- K042713 — FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
- K042714 — FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
- K042916 — WATCH PAT 100S
- K042975 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
- K043068 — DIFOTI USB 2.0 SYSTEM
- K043162 — PMP4 OXY PRO
- K043167 — PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
- K043211 — ONLINE DAT BARBITURATES PLUS
- K043378 — DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.