FDA 510(k) clearances — page 909
clearances on record, most recent first.
Clearances — page 909
90,801–90,900 of 176,637- K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM
- K974880 — PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
- K980904 — MUCHECK MONITOR UNIT VALIDATION PROGRAM
- K980946 — MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
- K980970 — IIRAD DIRECTRAY OPERATOR CONSOLE
- K981027 — E.CAM LSO 311 PET/SPECT SYSTEM
- K981216 — AMY
- K981543 — OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
- K981560 — IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
- K981581 — IRON
- K981622 — DADE TRU-LIQUID CARDIAC CONTROL
- K981840 — CO2
- K962959 — PERACIDIN DIALYZER REPROCESSING CONCENTRATE
- K972859 — FLUTTER D
- K973201 — PROVI CEMENT
- K980162 — MACH-SIGMA HANDPIECE, ULTRAPUSH
- K980882 — SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
- K980927 — LACTOSORB PANELS AND FASTENERS
- K980929 — DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES
- K980996 — COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
- K981088 — MILLS COLUMELLA PROSTHESIS
- K981133 — POWDERED NITRILE EXAMINATION GLOVES
- K981138 — ETEST CIPROFLOXACIN
- K981203 — RUSCH BLAKEMORE 3 LUMEN, STERILE
- K981234 — FLARE,FILE, FILL
- K981237 — QUANTA LITE RIBOSOME P ELISA
- K981312 — 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K981430 — UNION MEDICAL UM-D30 COAGULATOR
- K981447 — DIO-LIGHT 60 LASER SYSTEM
- K981667 — HYDROPHILIC COATED GUIDEWIRE
- K981770 — RAPIDHCG PREGNANCY TEST
- K970689 — IAB-04840-U; IAB-04250-U; IAB-04240-U; IAB-04230-U
- K972881 — CES VASCULAR OCCLUSION SYSTEM
- K980867 — 3D-MSPECT
- K980914 — EMORY CARDIAC TOOL BOX
- K980959 — VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
- K981124 — ACCUDEXA BONE DENSITOMETER
- K981669 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
- K973888 — SMARTLOCK SAFETY SYRINGE
- K974344 — CT SCOPE
- K974363 — BECTON DICKINSON BLUNT PLASTIC CANNULA
- K974914 — SHELHIGH NO-REACT PERICARDIAL PATCHES
- K980850 — BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
- K980918 — JPACS
- K981609 — BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
- K981687 — QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
- K981722 — QUIDEL HOME PREGNANCY TEST
- K974792 — CS/3(TM) MONITORS*
- K980829 — 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
- K980838 — REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM
- K980843 — EXETER INTRAMEDULLARY BONE PLUG
- K981014 — ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
- K981021 — ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
- K964332 — EAGLE CENTURY STEAM STERILIZER
- K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
- K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
- K973936 — FOCUS RTP SYSTEM
- K974106 — ICON IMPLANT SYSTEM
- K974812 — COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
- K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
- K980826 — EQUIDOSE SOLID STATE DIODE DETECTORS
- K980952 — SNORE-CURE ANTI-SNORING APPLIANCE
- K981062 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES
- K981139 — ETEST CEFTRIAXONE
- K981159 — PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
- K981230 — ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
- K981370 — MIRACLE MIX CAPSULE
- K981398 — ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
- K981555 — DIASCREEN REAGENT STRIPS
- DEN980001 — DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND
- K974678 — B-D AUTO-INJECTOR
- K974771 — STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
- K980342 — ETEST CHLORAMPHENICAL
- K980348 — ETEST VANCOMYCIN
- K980780 — DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
- K980801 — J-FX BIPOLAR HEAD
- K980886 — BABYTHERM 8000 LDR
- K980994 — IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
- K981113 — PEDIATRIC PRC
- K981201 — OSTEOLOCK ACETABULAR CUP
- K981240 — CREATININE (CREA)
- K981296 — GEEN MEDISOX
- K981388 — MICRO-STRIP FOR COCAINE METABOLITES
- K981389 — DISPOSABLE RE-NEW FORCEPS
- K981489 — UROSURGE SPIRASTENT PLUS URETERAL STENT
- K981491 — UROSURGE FILASTENT URETERAL STENT
- K981700 — VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
- K972502 — SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
- K972849 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
- K974285 — PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
- K980338 — ETEST OFLOXACIN
- K980431 — SURGISIS
- K980558 — PAINBUSTER INFUSION SYSTEM
- K980763 — LYSONIX LIPOPLASTY ACCESS PORT
- K980961 — CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
- K980992 — IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
- K981012 — AIA-PACK MYOGLOBIN ASSAY
- K981134 — ETEST TETRACYCLINE
- K981250 — LICEMEISTER COMB
- K981512 — ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
Data sourced from openFDA. This site is unofficial and independent of the FDA.