FDA 510(k) clearances — page 912
clearances on record, most recent first.
Clearances — page 912
91,101–91,200 of 176,637- 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
- K980703 — PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
- K980777 — DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
- K980827 — LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
- K963364 — GLASS VAN GLASS SYRINGES
- K971994 — B-D ASSURE EAR THERMOMETER
- K974456 — CMVGEN
- K974649 — BIO-POST DENTAL POST SYSTEM
- K974711 — COAMATIC PLASMINOGEN
- K974883 — BACTEC MGIT 960 SYSTEM
- K980046 — BRONCHIAL CATHETER SYSTEM
- K980096 — OAC (OPTICAL ASPIRATING CURETTE)
- K980206 — IMMULITE ANTI-TG AB
- K980384 — TRIP TONOMETRY CATHETER, 18F
- K980385 — DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
- K980393 — SOPRANO CRYO-THERAPY SYSTEM
- K980508 — KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400
- K980510 — KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
- K980598 — EBNA-1 IGM ELISA TEST SYSTEM
- K980633 — ENDOSOLV E
- K980640 — HEELBO WAIST AND CHEST VEST
- K980650 — REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL
- K980661 — CERA E DENTAL ALLOY
- K980683 — TROVAFLOXACIN 10G, SENSI-DISC
- K980815 — ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
- K980833 — IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
- K980852 — GII SPINAL FIXATION SYSTEM
- K980965 — SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
- K980985 — SCMD-1000
- K981192 — MG
- K981218 — CREATINE KINASE (CK)
- K981241 — IRON
- K981270 — IRMA BLOOD ANALYSIS SYSTEM
- K981276 — N-ASSAY L D-BIL
- K981282 — ELECSYS AFP
- K981336 — TBIL
- K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
- K981368 — PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS
- K981382 — PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS
- K970098 — E100 SERIES SPO2 SENSORS
- K970139 — MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
- K970211 — MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR
- K970460 — NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
- K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
- K972419 — TOENNIES NEUROSCREEN SYSTEM
- K972705 — RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
- K973170 — SIS WOUND DRESSING
- K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
- K973741 — BAIR HUGGER BLOOD/FLUID WARMER
- K973834 — CS2000 & CS2000 TOMO
- K974438 — MEDRAD ATD-T INTERFACE DEVICE
- K980383 — MOOORLDI LASER DOPPLER IMAGER
- K980399 — PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
- K980400 — PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
Data sourced from openFDA. This site is unofficial and independent of the FDA.