FDA 510(k) clearances — page 904
clearances on record, most recent first.
Clearances — page 904
90,301–90,400 of 175,890- K980603 — ETEST TROVAFLOXACIN
- K980649 — PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
- K981413 — SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
- K981455 — THIRD GENERATION PSA CONTROL MODULE
- K971408 — SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
- K973820 — USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
- K973922 — ARCHIMED 4210 AND 4220
- K974196 — MEGAVAC SYSTEM
- K980076 — PREMIER PLATINUM HPSA
- K980337 — DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
- K980530 — PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13
- K980671 — COLOSCREEN-ES
- K980726 — ULTRA-BLASTER
- K980810 — SERAQUEST ANTI-SSA
- K980811 — SERAQUEST ANTI-SM/RNP
- K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
- K980859 — HEMOCOR HPH MINI HEMOCONCENTRATOR
- K981059 — ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
- K981231 — CO2
- K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
- K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
- K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
- K981427 — STAT PROFILE M ANALYZER
- K981532 — LYPHOCHEK IMMUNOASSAY PLUS CONTROL
- K973561 — MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
- K973955 — HERNIAMESH SURGICAL MESHES
- K974038 — THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT
- K974560 — CORDIS VANGUARD STEERABLE GUIDEWIRES
- K980021 — EXTENTRAC
- K980065 — C/T MED-SYSTEMS CASSETTE SYSTEM
- K980512 — LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW
- K980595 — DEPUY ORTHOTECH CATERA SUTURE ANCHOR
- K980624 — CARDIOSTATION
- K980645 — PHILIPS GYROSCAN NT RELEASE 6 SERIES
- K980691 — AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K980704 — SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K980741 — BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
- K980809 — LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
- K980844 — SURGIDEV SILICONE PUNCTUM PLUG
- K980863 — DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
- K980892 — HAKOMED ELECDT / PRO ELEDT SERIES
- K980928 — SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
- K980942 — REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
- K980958 — HAKOMED ELECDT/VACUPULLS
- K980963 — HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
- K980986 — PROCAD
- K980988 — AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
- K981128 — SOFSILK SUTURE
- K981259 — OSTEO 4.0MM CANNULATED SCREW SYSTEM
- K981327 — INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
- K981372 — SYNTHES 3.0 MM PC-FIX SYSTEM
- K981392 — ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
- K981516 — STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
- K980577 — PRINCESS SYRINGE
- K980694 — KSEA PLASTIC TROCARS
- K980808 — ENDO FMS UROLOGY
- K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
- K981505 — COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
- K981510 — SONOACE 6000/ ULTRAMARK 400
- K971831 — QUICK CHECK INSTANT THERMOMETER
- K973646 — BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
- K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM
- K973924 — FRIOS BONESHIELD
- K974533 — TRIMPORT
- K980495 — MUSE CARDIOVASCULAR INFORMATION SYSTEM
- K981019 — QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
- K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
- K981079 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
- K981183 — CARESIDE GLUCOSE
- K981185 — GLU
- K981189 — URIC ACID
- K981305 — OLYMPUS SERUM PROTEIN MULTICALIBRATOR
- K981472 — DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
- K981474 — CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
- K973658 — DIFFUSION PACKAGE / GYROSCAN NT
- K980246 — NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
- K980308 — ECHOTECH 3D FREESCAN
- K980444 — SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
- K980445 — SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
- K980446 — SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
- K980462 — SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
- K980463 — SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
- K980479 — QUICK-CUT AUTOMATIC BIOPSY SYSTEM
- K980567 — CHARGER (ED)
- K980629 — VSS, VIRTUAL SIMULATION SYSTEM
- K980646 — IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
- K980684 — VR NETSERVE
- K980715 — AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
- K980752 — XTEND
- K981267 — FACTS MONOBLOCK
- K963658 — EXEL AVF SINGLE NEEDLE
- K972020 — OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
- K980428 — BIOMET BIAXIAL TOTAL ELBOW
- K980456 — JOBST ATHROMBIC PUMP SYSTEM 2600
- K980460 — ONPLANT ORTHODONTIC SYSTEM
- K980502 — OSTEONICS TOTAL ELBOW SYSTEM
- K980594 — OSTEONICS FX-CABLELOK GRIP COMPONENTS
- K980417 — MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
- K980420 — LIGHTSHEER
- K980480 — SYNTEC VITMAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.