FDA 510(k) clearances — page 735
clearances on record, most recent first.
Clearances — page 735
73,401–73,500 of 175,825- K023835 — DEVEX MESH SYSTEM
- K030049 — MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
- K030191 — TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
- K030206 — APEX 90
- K021963 — BIOSORB RESORBABLE VOID FILLER
- K022846 — SW-180 SHORTWAVE THERAPY UNIT
- K023004 — LFRE INDIRECT LARYNGOSCOPE
- K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC)
- K023579 — GAS SAMPLING LINES
- K023764 — UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
- K023802 — SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
- K023851 — PRECIMED HIP SCREW SYSTEM
- K023901 — ALUMINA V40 FEMORAL HEADS
- K023935 — TRILUMINA THERAPEUTIC LASER SYSTEM
- K024081 — DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
- K024174 — NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
- K024348 — MONARCH SPINE SYSTEM
- K024373 — MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
- K030031 — SOFT TISSUE ANCHORING WASHERS
- K030083 — VAXCEL WITH PASV PORT
- K030150 — LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS
- K020892 — ACIST GENTOO CONTRAST INJECTION SYSTEM
- K021750 — LID CHAIN EYELID WEIGHTS
- K022341 — TERABYTE 2000 HAIR REMOVER
- K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.
- K022366 — CELSIUS CONTROL SYSTEM
- K022929 — PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210
- K022951 — CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
- K023254 — SPEEDICATH
- K023624 — SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
- K023967 — PALOMAR Q-YAG ND:YAG LASER SYSTEM
- K023971 — VACUETTE TRACE ELEMENTS TUBES
- K024040 — ACCURA ELITE SHUNT SYSTEM
- K024101 — PHOENIX UNIVERSAL SHUNT SYSTEM
- K030002 — LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
- K012423 — MUCOGRAFT
- K020586 — GOOD LUBRICATIONS
- K021547 — FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
- K022052 — 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
- K022192 — PEGASUS NASAL CPAP SYSTEM
- K022433 — NEOGENESYS 2K
- K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
- K022697 — TEH LIN JUPITER POWER CHAIR, MODEL TL-320
- K023040 — WU'S 3-WHEELED NEO SCOOTER, WT-L3
- K023148 — EPW POWERED WHEELCHAIR, GP-201
- K023166 — WU'S 3-WHEELED NEO SCOOTER, WT-M4
- K023168 — WU'S 3-WHEELED NEO SCOOTER, WT-T3B
- K023512 — PICUS ULTRASOUND IMAGING SYSTEMS
- K023568 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K023612 — SILVERLON CONTACT WOUND DRESSING
- K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM
- K023640 — PICCOLO HDL TEST SYSTEM
- K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
- K023650 — INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
- K023826 — SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
- K023831 — UCP DENTAL MATERIAL
- K023866 — POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
- K023878 — GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
- K023970 — QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
- K023977 — PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
- K023978 — NITRILE EXAMINATION GLOVES, POWDER FREE
- K023979 — NITRILE EXAMINATION GLOVES, PRE-POWDERED
- K024021 — NITREX NITINOL GUIDEWIRE
- K024028 — SHARP VIEW IMAGE ENHANCEMENT SYSTEM
- K024103 — IVUS PLUS
- K030019 — MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
- K030078 — BURBANK TENACULUM, MODEL 09-0011-01
- K030090 — H2 HEATED HUMIDIFIER
- K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
- K030179 — MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
- K022143 — INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
- K022447 — BARD ER URETERAL STENT WITH SUTURE
- K022602 — DRX3000
- K023114 — LUMEND FRONTRUNNER CTO CATHETER
- K023613 — AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
- K023678 — DIMISIL SCAR GEL
- K023743 — SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
- K023776 — XENO III DENTAL ADHESIVE
- K023804 — MOSS MIAMI SPINAL SYSTEM PIN NUT
- K023934 — RAPID THERMAL EXCHANGE SYSTEM
- K023941 — SYNTHES TOMOFIX OSTEOTOMY SYSTEM
- K024022 — OSTEO-CABLE SLEEVE
- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K024326 — SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
- K030047 — FREEDOM CONSTRAINED LINERS
- K030089 — TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS
- K011754 — EXEL SECURETOUCH PTP SYRINGE
- K022365 — STRYKER NAVIGATION SYSTEM - HIP MODULE
- K022884 — CANDELA SMOOTHBEAM LASER SYSTEM
- K023128 — NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
- K023575 — CONCERT CRANIOPLAST
- K023618 — SONICAID ONE
- K023751 — EXAJET
- K023850 — SYDNEY IVF EMBRYO BIOPSY MEDIUM
- K023930 — COOPERSURGICAL OOCYTE RECOVERY NEEDLES
- K024177 — ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
- K024248 — MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
- K030064 — ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
- K010714 — EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
- K013884 — BOUSSIGNAC C.P.A.P. DEVICE
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