FDA 510(k) clearances — page 1288
clearances on record, most recent first.
Clearances — page 1288
128,701–128,800 of 175,890- K895502 — MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
- K895508 — CALASEPT PASTE
- K895523 — PHASE II ORTHODONTIC ADHESIVE
- K895630 — B-D PEND NEEDLE
- K895676 — HEMOSTAT/STIMULATOR PROBE
- K895707 — EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
- K896069 — WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
- K896292 — 1.2 MICRON FILTER WITH IV SET
- K896694 — VENTREZYME VAST SPECIFIC IGE ASSAY
- K883852 — CATHETER, CARDIOVASCULAR, BALLOON TYPE
- K892368 — RMI CARDIOPLEGIA DELIVERY SETS
- K892377 — RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
- K895421 — CORTISOL TEST SYSTEM
- K895521 — RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)
- K895522 — LIGHT BOND PASTE W/FLUORIDE
- K895550 — K-1 INFANT TRANSPORT SYSTEM
- K895661 — GLYCOTEST II GLYHB ASSAY KIT
- K895703 — DIATEK MODEL 700 THERMOMETER
- K895721 — MILLAR MIKRO-TIP PULSE TRANSDUCER
- K895779 — MODIFIED PERMCATH TRAY (2ND SUBMISSION)
- K895782 — NEONATAL INCUBATOR (ACCESSORY)
- K895789 — UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
- K895816 — BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
- K891237 — MODEL 600 SYRINGE PUMP
- K893646 — VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
- K894778 — CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
- K896093 — A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT
- K896156 — COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
- K896383 — DISPOSABLE EXTERNAL CLAMPS
- K896538 — DISPOSABLE 45 DEGREE SHAVER
- K896601 — EXACTECH BONE SCREW
- K891121 — MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
- K891719 — TRU-TOUCH VINYL, NON-STERILE
- K892073 — TAGUM LATEX EXAMINATION GLOVES
- K892327 — TRU-TOUCH VINYL, STERILE
- K892328 — FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES
- K892926 — DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
- K893357 — LATEX EXAMINATION GLOVES
- K893660 — ECG SIMULATOR MODEL ECGPLUS
- K894308 — PATIENT EXAMINATION GLOVES
- K894748 — IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
- K895322 — LATEX EXAMINATION GLOVES
- K895642 — LATEX PATIENT EXAMINATION GLOVES
- K895783 — IMPEDANCE ANALYZER MODELS MD-2, MD-P
- K895784 — IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
- K895785 — AUDIOMETER MODEL MD-4, MD-4P
- K895821 — URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS
- K895850 — SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
- K896220 — NON-STERILE LATEX EXAMINATION GLOVES
- K896347 — IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
- K892412 — POLYETHER-RETARDER
- K892453 — KULZER GLAS-IONOMER CEMENT
- K895104 — AQUATREX UNDERWATER TREADMILL SYSTEM
- K895393 — SARNS INGANT MEMBRANE OXYGENATOR
- K895401 — NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM
- K895434 — ALCON FOLDING FORCEPS
- K895663 — SITE 810E PHOTOCOAGULATOR AND ACCESSORIES
- K895958 — BREVET FLOSS PICK (AUTOCLAVE STERILIZER)
- K896131 — GNATHOMAT ARTICULATOR
- K896367 — STERILE SURGICAL DRAPES AND SHEETS
- K896585 — MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
- K896592 — CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
- K883400 — OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
- K891493 — PATIENT EXAMINATION GLOVES (LATEX)
- K892279 — PATIENT EXAMINATION GLOVES
- K892890 — STETH-SHIELD(TM)
- K894986 — 3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
- K895157 — S.A.F. ACETABULAR CUP
- K895362 — BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
- K895406 — OSBON PERSONAL LUBRICANT
- K895480 — BLUNT NEEDLE PORT/I.V. PORT
- K895488 — LATEX PATIENT EXAMINATION GLOVES
- K895809 — MILENIA(TM) HCG (MKCG1,5)
- K895831 — NEEDLEPOINT GUARD
- K895870 — ISOSCREEN-CK CONFIRMATORY KIT
- K895886 — BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
- K895912 — IMMUNOCARD HCG II-S TEST KIT
- K896135 — STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
- K896163 — SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
- K896196 — ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR
- K896207 — OSBON PERSONAL LUBRICANT
- K896291 — INJECTION PORT II --- FOR INTERMITTENT INJECTION
- K896483 — QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
- K896545 — ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
- K890310 — STERILE FOLEY CATHETER
- K892584 — TON-SU'S VINYL EXAM GLOVES
- K892721 — IFA SENSIBAC CEFACLOR
- K894093 — SPACELABS MODEL 90900
- K894446 — ANGEION HEMOSTASIS VALVE INTRODUCER
- K894541 — CARRINGTON DERMAL WOUND GEL
- K894878 — 16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
- K894879 — 16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
- K894880 — 16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
- K894881 — 20GA X 7-1/2 THREADING BULLET POINT NEEDLE
- K894882 — INFILTRATION PUMP SYRINGE
- K895278 — SCD KNEE IMMOBILIZER
- K895518 — COHERENT HOLMIUM:YAG SURGICAL LASER
- K895966 — MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
- K896090 — DEVILBISS MODEL 6300D
- K896117 — MODIFIED MODEL 535(TM) LUMINOMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.