FDA 510(k) clearances — page 605
clearances on record, most recent first.
Clearances — page 605
60,401–60,500 of 176,637- 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
- K070813 — ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
- K070850 — FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
- K061505 — POWERED NITRILE BLUE EXAMINATION GLOVES
- K062261 — FOAM RING PORT PROTECTOR
- K062545 — RMI LCD ALCOHOL DETECTOR
- K063720 — VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
- K070641 — ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
- K070734 — MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
- K061812 — COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
- K061846 — COMBI SCAN100
- K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
- K063501 — KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
- K063872 — KINESIA
- K070051 — ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
- K070166 — STRADA CAROTID GUIDING SHEATH
- K070218 — VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)
- K070624 — HYPERQ SYSTEM
- K070671 — OPUS SMARTSTITCH SUTURE DEVICE
- K070707 — MICRUS MICROCOIL SYSTEM
- K070792 — QLAB QUANTIFICATION
- K070796 — CHILI PACS
- K070803 — INVIVODENTAL
- K070818 — MEDILOGAR4, MEDILOGAR12
- K061479 — ARGOS
- K062284 — CES ULTRA
- K063458 — 3M TEGADERM CHG DRESSING
- K070211 — TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
- K070245 — CAPSURE PEDICLE SCREW SYSTEM
- K070352 — MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM
- K070390 — FLUOROPRO RF DIGITAL IMAGING SYSTEM
- K070505 — KRYSTAL-X WIFI
- K070523 — MODIFICATION TO: VELSCOPE
- K070657 — GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
- K070658 — DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM
- K070680 — CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080
- K070686 — MINI LAP INSTRUMENTS
- K070738 — SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
- K062682 — CVS PERSONAL LUBRICANT AND MOISTURIZER
- K063139 — SPINAL STABILIZING SPHERE SYSTEM
- K063565 — QUANTA LITE SS-A 52 ELISA
- K063728 — TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
- K063848 — POWERGROSHONG PICC CATHETER
- K070108 — ELIBRA DYNAMIC KNEE BALANCER
- K070182 — ZYGOMA IMPLANT (IMMEDIATE FUNCTION)
- K070221 — FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
- K070430 — PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS
- K070659 — BIOLUCENT APPLICATOR KIT
- K062083 — SYNFIX -LR
- K062963 — PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
- K063791 — CORIN UNIPOLAR MODULAR HEAD
- K070273 — MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM
- K070274 — ECHO BI-METRIC PRESS-FIT STEMS
- K062957 — FASTPACK TOTAL PSA METHOD VERIFICATION KIT
- K063061 — CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
- K063159 — STERILOX LIQUID CHEMICAL STERILANT SYSTEM
- K063216 — RESCUE INTERNAL IMPLANT SYSTEM
- K070016 — BLUE SHARK
- K070233 — CONMED LINVATEC SMART GUARD IRRIGATOR
- K070546 — LYPHOCHEK DIABETES CONTROL
- K070602 — C.T.M. MOBILITY SCOOTER# HS-265
- K070644 — GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
- K070655 — WU'S POWERED WHEELCHAIR, MAMBO 36
- K070673 — FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
- K050415 — IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
- K062120 — CISBIO RENIN RIA TEST
- K063321 — D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
- K063674 — EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
- K063769 — ALPHA BIO BONE FIXATION SCREW SYSTEM
- K070215 — TOKUYAMA BOND FORCE
- K070729 — BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
- K063076 — REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
- K063452 — MA 55 MAESTRO
- K063874 — DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM
- K070127 — PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
- K070177 — FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
- K070334 — R&D SICKLE QC CONTROL
- K070384 — ARGON CONTINUOUS FLUSH DEVICE
- K070402 — MODIFICATION TO POLAR CARE 500
- K070447 — NEWDEAL COMPRESSION PLATE
- K070507 — MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
- K070525 — CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
- K070548 — C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
- K070551 — MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
- K070635 — HEMOSIL PROCLOT
- K070697 — COE SOFT
- K070698 — COE COMFORT
- K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
- K070041 — POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.