FDA 510(k) clearances — page 710
clearances on record, most recent first.
Clearances — page 710
70,901–71,000 of 175,825- K030857 — MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
- K031012 — ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK
- K031189 — UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
- K031278 — STRYKER FLEXIBLE URETEROSCOPE
- K031335 — POWDER FREE LATEX EXAM GLOVES
- K031501 — EASYGLUCO, MODEL IGM0002
- K031966 — ENK FIBEROPTIC ATOMIZER SET
- K032226 — LTV-1000 VENTILATOR
- K032257 — MODEL IR 1200 INSULIN PUMP
- K032340 — VISTAKON (GALYFILCON A) SOFT CONTACT LENS
- K032428 — MAGNETOM AVANTO MR SYSTEM
- K032456 — PROWESS
- K032480 — AUTOSET SPIRIT SYSTEM
- K032533 — INTELEPACS
- K032546 — HOLOGIC DR IMAGEPRO
- K033009 — ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
- K033099 — ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
- K033196 — SONOLINE ANTARES WITH CLARIFY VE
- K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- K033244 — DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
- K030468 — ACURA ELITE GRAVITY COMPENSATING RESERVOIR
- K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
- K031074 — DIGITAL AMBULATORY ECG (HOLTER) RECORDER
- K031301 — ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
- K031408 — DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
- K031474 — SC TOTAL HIP SYSTEM
- K031732 — EBI ACUMEN SURGICAL NAVIGATION SYSTEM
- K032167 — BIO-INTRAFIX TIBIAL SCREW AND SHEATH
- K032178 — RHYTHM TOUCH Q 2-WAY
- K032223 — COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH
- K032408 — DAMON FT
- K032683 — GENESIS II POROUS PLUS HA KNEE SYSTEM
- K032792 — PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
- K032919 — C.T.M. MOBILITY SCOOTER, MODEL HS-250
- K032926 — EKG SPEAKS
- K032997 — MODIFICATION TO: HORIZON 9000WS
- K033179 — MEDELA CLARIO HOME CARE PUMP
- K031769 — E-STRIP
- K032186 — AUTOALIGN
- K032661 — ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
- K032868 — REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
- K032904 — ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
- K033165 — PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
- K033185 — COBAS INTEGRA ALP IFCC GEN.2
- K033214 — EKOS PERIPHERAL INFUSION SYSTEM
- K023209 — INSIGHT MILLENNIUM III
- K030539 — LASERSMILE
- K030737 — OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
- K030910 — CLUED UP MULTIPURPOSE SOLUTION- NO RUB
- K030998 — MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
- K031195 — CUF-COVER (TM)
- K031465 — MODEL 2100 PULSE OXIMETER
- K031471 — ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
- K031607 — ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
- K031760 — VIEWPOINT TELEMETRY SYSTEM
- K031797 — METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
- K031840 — CAREMATIX WELLNESS SYSTEM
- K031863 — CARESTATION 126S VIDEOPHONE
- K031901 — PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
- K032071 — POWDER FREE VINYL EXAMINATION GLOVE
- K032115 — NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
- K032201 — RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
- K032279 — ONLINE TDM AMIKA
- K032290 — FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
- K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
- K032413 — KLS-MARTIN STERNAL PLATING SYSTEM
- K032467 — MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
- K032471 — TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
- K032577 — MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
- K032620 — GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
- K032837 — HL888BM
- K032839 — HL888BA
- K032858 — THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
- K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
- K032924 — RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
- K032956 — ACCUSONIC A-SCAN MODEL, 24-4000
- K033010 — BRM2 BRAIN MONITOR
- K033043 — MODIFICATION TO HL168
- K033073 — ORTHOPHOS XG DS/CEPH
- K033151 — KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
- K033152 — HAC-12 AND HAC-30 HEAD ARRAY COIL
- K033162 — LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
- K033168 — GE 0.2T SIGNA PROFILE/I MR SYSTEM
- K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT
- K024361 — EM PROBE, EM PAD
- K030472 — MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
- K031061 — NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
- K031125 — CYNOSURE SMART FILE ND:YAG LASERS
- K031265 — SHIRAZ-JAVA SPINAL FIXATION SYSTEM
- K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
- K032175 — DESENS-IONOMER
- K032196 — NBD DISPOSABLE RF CANNULAE
- K032300 — ACCOLADE-J HIP STEM SERIES
- K032357 — NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
- K032368 — SONOMA ANTERIOR CERVICAL PLATE SYSTEM
- K032427 — FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
- K032506 — SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
- K032581 — GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
- K032654 — PORT CASSETTE
- K032700 — BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
Data sourced from openFDA. This site is unofficial and independent of the FDA.