FDA 510(k) clearances — page 1295
clearances on record, most recent first.
Clearances — page 1295
129,401–129,500 of 176,637- K895292 — LYME IGG ELISA TEST SYSTEM
- K895444 — THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION
- K895581 — MODEL: IR205 ARTICULATED SURGICAL LASER
- K895691 — VASCULAR CLAMP
- K895916 — PE INTERCARDIAC MAPPING SYSTEM (ICMS)
- K896112 — TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS
- K896113 — TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
- K896114 — TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
- K896115 — TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER
- K896155 — RED DOT CARDIAC SENSOR SYSTEM
- K896221 — CARDS O.S.(TM) STREP A
- K896386 — MINIMON 7133B PATIENT MONITOR
- K896490 — CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
- K896533 — SPENCO BREAST FORMS
- K896632 — MEDTRONIC MODEL 5401B TEST CABLE
- K893207 — CLOSED CHEST SUPPORT CIRCUIT
- K894355 — DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
- K895208 — ZYMED MODEL 1610
- K895397 — CALCIUM AND PH ELECTROLYTE ANALYZER
- K895632 — SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
- K895651 — MARQUETTE 1200 DEFIBRILLATION PADS
- K895873 — CALCIUM, CATALOGUE NUMBER140-20
- K895936 — EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
- K896073 — CHOLESTEROL, UNIVERSAL ET
- K896270 — AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
- K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
- K896417 — KONTRON KOLORMON 7250 PATIENT MONITOR
- K896451 — MODIFIED CEDIA(TM) CORTISOL ASSAY
- K892091 — PATIENT EXAMINATION GLOVES (LATEX)
- K892636 — PATIENT EXAMINATION GLOVES (LATEX)
- K893513 — PATIENT EXAMINATION GLOVE/MANUF. KUN SHAN FACTORY
- K894213 — SPRING LATEX EXAMINATION GLOVES
- K895637 — LATEX EXAM GLOVES (MFG. SUPER GLOVE INDUSTRY CO.)
- K895657 — PATIENT EXAMINATION GLOVES (NON STERILE)
- K895675 — PAP SMEAR TRAY
- K895708 — EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
- K895848 — PRESSURE STEAM STERILIZERS
- K896306 — GLOVE N GEL
- K896334 — CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
- K896335 — CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR
- K896399 — WHITE MAGNOLIA DENUDATE LATEX EXAMINATION GLOVES
- K896625 — THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
- K884890 — LORD L.F.R. TOTAL HIP SYSTEM
- K884920 — RECTUM-COLON MOTILITY MONITOR
- K894068 — KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM
- K894939 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
- K895473 — DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.