FDA 510(k) clearances — page 645
clearances on record, most recent first.
Clearances — page 645
64,401–64,500 of 176,637- K052964 — EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
- K053029 — NDR+/DIVA-D
- K053062 — CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2
- K053210 — MAYFIELD SCANMATE MOBILE CT SYSTEM
- K053220 — VERAVIEW IC 5, MODEL XDP1
- K053242 — PITT-EASY DENTAL IMPLANT SYSTEM
- K053322 — MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
- K053326 — ESTECH COBRA ELECTROSURGICAL UNIT & CABLE
- K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
- K053437 — EKOS MICRO-INFUSION SYSTEM
- K053445 — SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
- K053474 — CD HORIZON SPINAL SYSTEM
- K051847 — KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
- K053101 — CD HORIZON SPINAL SYSTEM
- K053136 — 5TH METATARSAL FRACTURE SCREW
- K053209 — TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
- K053272 — CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
- K053285 — MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
- K053299 — REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
- K053324 — CHROMOLITE SYSTEM
- K053483 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K051113 — QUANTA SYSTEM ETRNA GIOVINEZZA
- K051880 — RIO ASPIRATION CATHETER
- K051990 — ECHELON MICRO CATHETER
- K052301 — FASTPACK TSH IMMUNOASSAY
- K052697 — HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
- K052925 — SMARTPREP2 CENTRIFUGE SYSTEM
- K053135 — SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
- K053168 — BIPAP FOCUS
- K053347 — KODAK CARESTREAM PACS
- K053486 — TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET
- K051188 — GRAFTON DBM
- K051933 — EXPASYL POWER APPLICATOR
- K052119 — TESLAGUARD, MODEL EFT G04
- K052272 — STRAUMANN COMPUTER AIDED RESTORATION SERVICE
- K052316 — POWERHEART ECD
- K053065 — FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
- K053530 — SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
- K051603 — STRYKER INJECTABLE CEMENT
- K052320 — ENCORE CLP OFFSET TOTAL HIP SYSTEM
- K052795 — PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
- K052862 — FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
- K052988 — CAAS
- K053016 — WIRELESS PHYSIOLOGIC MONITORING SYSTEM
- K053020 — TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
- K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
- K053303 — CARDIOCOM COMMANDER III
- K053304 — COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
- K053432 — EKOS MICRO-INFUSION SYSTEM
- K053440 — AMPLATZER SIZING BALLOON II
- K052115 — FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
- K052972 — DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
- K053266 — MYOTRAC INFINITI
- K053308 — ABX MICROS CRP 200, OPTION IM
- K052425 — ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
- K052725 — PROTECTOR NEEDLE SHEATH PROP
- K052735 — ALLOCRAFT DBM
- K053503 — VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
- K050365 — BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
- K051290 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
- K051903 — FETALGARD LITE-NIBP, MODEL FGL-NIBP
- K052265 — SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
- K052385 — TANGORS POLYAXIAL SYSTEM
- K052587 — 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
- K052678 — AQ-830 SLIM BODY, BODY FAT MONITOR
- K052706 — A-200 POWERED WHEELCHAIR
- K052787 — ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
- K052848 — SPECTRA HAIR REMOVAL LASER
- K052875 — PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
- K052917 — STRYKER COMPARTMENTAL KNEE SYSTEM
- K052942 — 21.3INCH MONOCHROME LCD MONITOR
- K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR
- K053276 — IST PEDICLE SCREW SYSTEM
- K053414 — MENTOR NOVASILK MESH
- K053447 — ARTHROCARE PERC-D SPINEWAND
- K053482 — SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
- K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
- K051030 — COAG-A-MATE MTX III
- K051041 — INSULIN PUMP
- K051472 — BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
- K052283 — HEART STG SYSTEM AND SOFTWARE
- K052471 — HDC SPIDER SCREW
- K052562 — ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
- K052669 — AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
- K052751 — VENTLINK SYSTEM
- K052790 — SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
- K052819 — VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
- K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
- K052867 — VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
- K052885 — ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315
- K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
- K053109 — DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
- K053140 — AMBU MARK IV RESUSCITATOR
- K053395 — BP PRO BLOOD PRESSURE MONITOR
- K042404 — LIFEPAK, MODEL 1000
- K050758 — CHEMPAQ XBC ANALYZER
- K050843 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
- K051257 — ADULT CEREBRAL OXIMETER, MODEL 2040
- K051487 — DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.