FDA 510(k) clearances — page 1297
clearances on record, most recent first.
Clearances — page 1297
129,601–129,700 of 175,890- K894517 — FPR AMIKACIN KIT
- K894518 — FPR AMIKACIN CALIBRATOR KIT
- K894523 — FPR GENTAMICIN KIT
- K894524 — FPR GENTAMICIN CALIBRATOR KIT
- K894765 — SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
- K894804 — SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
- K894852 — SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
- K894962 — CO2 LASER BRONCHOSCOPE COUPLER
- K894996 — EXUSORB(TM) GRANULES
- K895004 — MILENIA(TM) TOTAL IGE (MKIE1,5)
- K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM
- K895353 — OPSITE I.V. 3000
- K895398 — BIO-COORDINATOR SYSTEM
- K895568 — PRIMIDONE (FPIA) CALIBRATOR KIT
- K895570 — VALPROIC ACID (FPIA) CALIBRATOR KIT
- K892635 — PATIENT EXAMINATION GLOVES (LATEX)
- K893624 — PREEMICARE MODEL 2500 TRANSPORT WARMER
- K894150 — COUNTERBORE FOR SS SUBMERGED SCREW PLANT
- K894151 — IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT
- K894298 — MODIFIED GEMINI ACETABULAR CUP
- K894414 — HEARING AID (IN-THE-CANAL)
- K894487 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
- K895042 — SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY
- K895109 — SECONDARY IV SET WITH PROTECTED NEEDLE
- K895212 — TIK EXTRAKTOR
- K895258 — LATEX PATIENT EXAMINATION GLOVES
- K895277 — ORTHO APO B ELISA TEST SYSTEM
- K895369 — VOSS GRAFT MARKER
- K895598 — WAKO(TM) AUTOKIT CRP
- K895670 — SURGICAL SUCTION APPARATUS
- K890597 — EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS
- K891513 — VINYL EXAMINATION GLOVES
- K892120 — ESCORT PULSE OXIMETRY OPTION
- K892505 — PATIENT EXAMINATION GLOVES
- K892530 — CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
- K892760 — PATIENT EXAMINATION GLOVES (LATEX)
- K892851 — ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER
- K892972 — 'JOBSTAR' PATIENT EXAMINATION GLOVES
- K893017 — SWED MED STERILE VINYL EXAMINATION GLOVES
- K893105 — SAFETY TOUCH VINYL EXAMINATION GLOVES
- K893336 — LATEX EXAMINATION GLOVES
- K893435 — SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
- K893471 — MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
- K893626 — FLEXMEDICS GUIDEWIRE
- K893685 — CERAMIC FEMORAL HEAD
- K893749 — CN GLOVES
- K894065 — OPUS MODEL 4001
- K894131 — DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000
- K894138 — MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
- K894182 — IMX TOTAL B-HCG
- K894255 — ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
- K894277 — M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
- K894281 — FIRST IMPRESSION WITH CHLORHEXIDINE
- K894285 — DMI PC HOLTER SCANNER
- K894343 — DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
- K894426 — LEONARDO INFORMATION SYSTEM
- K894454 — PATIENT EXAMINATION GLOVES, LATEX
- K894488 — DANTEX VINYL EXAMINATION GLOVES
- K894539 — SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
- K894616 — LATEX EXAMINATION GLOVES
- K894739 — SURE-TEC LATEX EXAMINATION GLOVES
- K894758 — PATIENT LATEX EXAMINATION GLOVES
- K894796 — LATEX PATIENT EXAMINATION GLOVE
- K894805 — RAPIDEC UR
- K894916 — COMFEEL TRANSPARENT DRESSING
- K894942 — SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
- K895027 — MEDPRIDE LATEX SURGEONS GLOVES
- K895092 — KUT-SHIELD
- K895110 — MAESTRO PACEMAKER TEST MAGNET
- K895425 — MINIMON 7137B PATIENT MONITOR
- K895495 — ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
- K895536 — LATEX PATIENT EXAMINATION GLOVES
- K895558 — ORIENT, LATEX EXAMINATION GLOVES
- K885220 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
- K891129 — SERIES 3 GENERAL SUCTION SYSTEM
- K892895 — MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
- K893569 — QUICK CHANGE MONTGOMERY STRAP
- K894097 — NTI-1000
- K894200 — FREE T3 RADIOIMMUNOASSAY KIT
- K894407 — ABBOTT SPECTRUM(R) CALCIUM REAGENT
- K894521 — FPR DIGOXIN KIT
- K894522 — FPR DIGOXIN CALIBRATOR KIT
- K894527 — FPR PHENYTOIN KIT
- K894528 — FPR PHENYTOIN CALIBRATOR KIT
- K895143 — COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS
- K895210 — LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
- K895376 — ACTIDERM (TM) DERMATOLOGICAL PATCH
- K891688 — COIL AND COIL DELIVERY SYSTEM
- K891928 — HOLTAIN BODY COMPOSITION ANALYSER
- K892670 — PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)
- K893745 — THE INDEPENDENT CARE UNIT
- K893786 — SERVO ANESTHESIA CIRCLE 985
- K894296 — PREMISE SERIES BED
- K894299 — REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
- K894316 — AMADEUS VENTILATOR
- K894405 — HTF WITH ALBUMIN (CATALOG NO. 9994)
- K894413 — X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
- K894432 — MODIFIED HAM'S F-10 W/ALBUMIN
- K894637 — NATIONAL MEDICAL CARE VENOUS LINE 03-9548
- K894872 — 16 GA X 6 BULLET POINT NEEDLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.