FDA 510(k) clearances — page 596
clearances on record, most recent first.
Clearances — page 596
59,501–59,600 of 175,825- K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
- K070247 — GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
- K070836 — EXICLIP EXCS-M
- K070954 — PATIENTGALLERY IMAGING SOFTWARE
- K070976 — RII INFRARED EAR THERMOMETER, MODEL TH01BN
- K061756 — TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
- K063059 — SORBACT WOUND DRESSING
- K070130 — ORBITAL RECONSTRUCTIVE IMPLANT
- K070254 — HORIZON SE
- K070316 — INTERPLATE VBR SYSTEM
- K070483 — LEONE MONOIMPLANT FOR O-RING OVERDENTURE
- K070710 — ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
- K070775 — MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
- K070943 — B-SCAN PLUS
- K071007 — HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
- K063346 — PRO OSTEON 500R
- K063468 — THE FUGO BLADE FOR DENTISTRY
- K070091 — COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208
- K070168 — N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
- K070181 — SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX
- K070506 — SMS MULTI GLUCOSE CONTROL, MODEL 2120049
- K070676 — KOREBALANCE (KINESTHETIC ABILITY TRAINER)
- K060915 — KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
- K062453 — KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138
- K063306 — ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
- K063354 — LINDE INTEGRATED VALVE (LIV)
- K063842 — CYRTINA SYSTEM
- K070172 — AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K070224 — ULTRAPRO PLUG
- K070243 — SUTRALENE POLYPROPYLENE SUTURES
- K070290 — SPI VECTODRILL CERAMIC DRILLS
- K070462 — XPERT MRSA
- K070466 — REVOLIX DUO LASER SYSTEM
- K070467 — HEALTH MASK
- K070907 — INTERSON USB ULTRASOUND PROBE SYSTEM
- K062102 — ODONCER
- K062130 — MEISINGER BENEX, MODEL BE001
- K063231 — MICROBLADE SHAVER AND ACCESSORIES
- K063271 — AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
- K063329 — ABBOTT ARCHITECT HAVAB-M
- K063359 — INQU
- K063784 — DYE MANAGEMENT SYSTEM
- K063790 — THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
- K070125 — COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
- K070174 — AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
- K070227 — OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
- K070278 — POLARCUP DUAL MOBILITY SYSTEM
- K070335 — SIMPLEX CERVICAL FIXATION SYSTEM
- K070583 — NANO COMPOSITE
- K070858 — EXPRESS SERIES
- K070950 — LIFT CHAIR, MODEL C5
- K062325 — RS-4I MUSCLE STIMULATOR FAMILY
- K062362 — SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS
- K062449 — EMPOWERMR INJECTOR SYSTEM, MODEL 9730
- K062526 — BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
- K063071 — DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
- K063125 — FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
- K063606 — MODIFICATION TO STAXX FX SYSTEM
- K070056 — VAPOTHERM MODEL# 2000I AND 2000H
- K070136 — AUDICOR 200 SYSTEM, MODELS 200D AND 200S
- K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR
- K070397 — DGSCOPE, RELEASE 1.0
- K070574 — FLEXITRON
- K070718 — MODIFICATION TO: BODYGUARD INFUSION SYSTEM
- K070745 — MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
- K070802 — LERADOTECH, MODEL SC
- K070817 — LERADOTECH SCOOTER, MODEL SB
- K070851 — ARTHROCARE SPINEWANDS
- K070871 — STARION UNIVERSAL POWER SUPPLY
- K070894 — TEPHAFLEX SURGICAL MESH
- K070904 — ANTLIA II SUCTION PUMP SYSTEM
- K053492 — BIODUCT
- K061277 — STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
- K061896 — MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N
- K062473 — LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871
- K062631 — MYOMO E100
- K070167 — ENDOBUTTON DIRECT
- K070220 — OSTEOFIX BONE VOID FILLER
- K070367 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
- K070454 — OMEGA 3 SUPRACONDYLAR PLATE
- K070649 — SMS GLUCOSE CONTROL, MODEL 2120061
- K070683 — MIRAGE CEDARS OPTION
- K070854 — GC MI PASTE PLUS
- K062194 — HYPERVISOR VI CENTRAL MONITORING SYSTEM
- K062797 — POWDERED LATEX SURGICAL GLOVE
- K063098 — STATIC CRANIOPLASTY ORTHOSIS
- K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY
- K070066 — QUANTA LITE RNA POL III ELISA
- K070504 — AMMONIA/ALCOHOL CONTROL SET
- K070674 — AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
- K070706 — EP-WORKMATE
- K070778 — NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL
- K070782 — WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
- K070847 — TRIAL CABLE, 3009
- K070866 — ASC-12 PIEZOELECTRIC SCALER
- K070884 — POD B-SCAN
- K063542 — WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
- K070143 — JMS PLANECTA STOPCOCK
- K070300 — EXPEDIUM SFX CROSS CONNECTOR SYSTEM
- K070519 — PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.