Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PE INTERCARDIAC MAPPING SYSTEM (ICMS) (K895916)Prucka Engineering, Inc.1989-12-13
LYME IGG ELISA TEST SYSTEM (K895292)Zeus Scientific, Inc.1989-12-13
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE (K895199)Baxter Healthcare Corp1989-12-13
MEDTRONIC MODEL 5401B TEST CABLE (K896632)Medtronic Vascular1989-12-13
MODEL: IR205 ARTICULATED SURGICAL LASER (K895581)Niic U.S.A., Inc.1989-12-13
VERIMED MYOEXORCISER III (MYO III) (K892649)Verimed Holdings, Inc.1989-12-13
CARDS O.S.(TM) STREP A (K896221)Pacific Biotech, Inc.1989-12-13
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER (K896115)Tambrands, Inc.1989-12-13
SPENCO BREAST FORMS (K896533)Spenco Medical Corp.1989-12-13
THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION (K895444)Mcvicar Enterprises, Ltd.1989-12-13
TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS (K896112)Tambrands, Inc.1989-12-13
AMCATH URETERAL DILATORS MODELS 7100,7110,7120 (K894925)Intec Medical, Inc.1989-12-13
HAEMOPHILUS TEST MEDIUM (HTM)AGAR (K894216)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-13
VASCULAR CLAMP (K895691)Applied Vascular Devices, Inc.1989-12-13
TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB. (K896114)Tambrands, Inc.1989-12-13
MINIMON 7133B PATIENT MONITOR (K896386)Kontron Instruments, Inc.1989-12-13
TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS (K896113)Tambrands, Inc.1989-12-13
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. (K894356)Phycon1989-12-13
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 (K895632)3M Company1989-12-12
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (K896270)Amersham Corp.1989-12-12
CALCIUM AND PH ELECTROLYTE ANALYZER (K895397)Ionetics, Inc.1989-12-12
KONTRON KOLORMON 7250 PATIENT MONITOR (K896417)Kontron Instruments, Inc.1989-12-12
MARQUETTE 1200 DEFIBRILLATION PADS (K895651)Marquette Electronics, Inc.1989-12-12
ZYMED MODEL 1610 (K895208)Agilent Technologies1989-12-12
MODIFIED CEDIA(TM) CORTISOL ASSAY (K896451)Microgenics Corp.1989-12-12
CALCIUM, CATALOGUE NUMBER140-20 (K895873)Diagnostic Chemicals, Ltd. (Usa)1989-12-12
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER (K895936)Medica Corp.1989-12-12
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. (K894355)Phycon1989-12-12
CHOLESTEROL, UNIVERSAL ET (K896073)Enzyme Technology, Inc.1989-12-12
CLOSED CHEST SUPPORT CIRCUIT (K893207)Medtronic Blood Systems, Inc.1989-12-12
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (K896329)Photec Diagnostics, Inc.1989-12-12
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER (K896334)Creative Laboratory Products, Inc.1989-12-11
GLOVE N GEL (K896306)Ems Medical, Inc.1989-12-11
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. (K896625)Medical Diagnostic Technologies, Inc.1989-12-11
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) (K895708)Immuno Concepts, Inc.1989-12-11
PATIENT EXAMINATION GLOVES (LATEX) (K892091)Rising Crown Industries , Ltd.1989-12-11
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR (K896335)Creative Laboratory Products, Inc.1989-12-11
PATIENT EXAMINATION GLOVE/MANUF. KUN SHAN FACTORY (K893513)Pioneer Sundries Products , Ltd.1989-12-11
WHITE MAGNOLIA DENUDATE LATEX EXAMINATION GLOVES (K896399)Prime Horizon, Inc.1989-12-11
PRESSURE STEAM STERILIZERS (K895848)Scientific Device Laboratory, Inc.1989-12-11
PATIENT EXAMINATION GLOVES (LATEX) (K892636)P.T. Latexindo Parama1989-12-11
SPRING LATEX EXAMINATION GLOVES (K894213)Brandywine Surgical, Inc.1989-12-11
PATIENT EXAMINATION GLOVES (NON STERILE) (K895657)Ka Hung Development , Ltd.1989-12-11
PAP SMEAR TRAY (K895675)Intl. Cytobrush, Inc.1989-12-11
LATEX EXAM GLOVES (MFG. SUPER GLOVE INDUSTRY CO.) (K895637)Transcontinental Fertilizer Co.1989-12-11
1.2 MICRON FILTER WITH IV SET (K896292)Kendall Mcgaw Laboratories, Inc.1989-12-08
LORD L.F.R. TOTAL HIP SYSTEM (K884890)Howmedica Corp.1989-12-08
PHASE II ORTHODONTIC ADHESIVE (K895523)Reliance Orthodontic Products, Inc.1989-12-08
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S (K895473)Medical Devices, Inc.1989-12-08
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM (K894068)Kirschner Medical Corp.1989-12-08
RECTUM-COLON MOTILITY MONITOR (K884920)Multi-Spectrum Consulting, Inc.1989-12-08
VENTREZYME VAST SPECIFIC IGE ASSAY (K896694)Ventrex Laboratories, Inc.1989-12-08
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (K895502)Microbio-Medics, Inc.1989-12-08
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) (K895707)Immuno Concepts, Inc.1989-12-08
HEMOSTAT/STIMULATOR PROBE (K895676)Rln Systems, Inc.1989-12-08
CALASEPT PASTE (K895508)Js Dental Mfg., Inc.1989-12-08
B-D PEND NEEDLE (K895630)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-08
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY (K894939)North American Sterilization & Packaging Co.1989-12-08
WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT (K896069)Wilson-Cook Medical, Inc.1989-12-08
DIATEK MODEL 700 THERMOMETER (K895703)Diatek, Inc.1989-12-07
NEONATAL INCUBATOR (ACCESSORY) (K895782)Air-Shields Vickers, Inc.1989-12-07
MODIFIED PERMCATH TRAY (2ND SUBMISSION) (K895779)Quinton, Inc.1989-12-07
GLYCOTEST II GLYHB ASSAY KIT (K895661)Pierce Chemical Co.1989-12-07
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 (K895789)Medtronic Vascular1989-12-07
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. (K895816)Bio-Rad1989-12-07
CATHETER, CARDIOVASCULAR, BALLOON TYPE (K883852)Wb Intl., Inc.1989-12-07
LIGHT BOND PASTE W/FLUORIDE (K895522)Reliance Orthodontic Products, Inc.1989-12-07
RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE) (K895521)Reliance Orthodontic Products, Inc.1989-12-07
K-1 INFANT TRANSPORT SYSTEM (K895550)K-1 Medical Products, Inc.1989-12-07
RMI CARDIOPLEGIA DELIVERY SETS (K892368)Research Medical, Inc.1989-12-07
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET (K892377)Research Medical, Inc.1989-12-07
CORTISOL TEST SYSTEM (K895421)Baxter Healthcare Corp1989-12-07
MILLAR MIKRO-TIP PULSE TRANSDUCER (K895721)Millar Instruments, Inc.1989-12-07
MODEL 600 SYRINGE PUMP (K891237)3M Company1989-12-06
DISPOSABLE EXTERNAL CLAMPS (K896383)Galenica Enterprises, Inc.1989-12-06
A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT (K896093)Therex Corp.1989-12-06
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER (K894778)Codman & Shurtleff, Inc.1989-12-06
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY (K893646)Baxter Healthcare Corp1989-12-06
COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM (K896156)Stereotactic Medical Systems, Inc.1989-12-06
EXACTECH BONE SCREW (K896601)Exactech, Inc.1989-12-06
DISPOSABLE 45 DEGREE SHAVER (K896538)Bowen & Company, Inc.1989-12-06
AUDIOMETER MODEL MD-4, MD-4P (K895785)Singer Medical Products, Inc.1989-12-05
PATIENT EXAMINATION GLOVES (K894308)Xing Huao Co. , Ltd.1989-12-05
LATEX EXAMINATION GLOVES (K895322)Advantage Resources1989-12-05
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 (K896347)General Biometrics, Inc.1989-12-05
LATEX EXAMINATION GLOVES (K893357)M.M. Rubber Co. , Ltd.1989-12-05
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (K895821)Catachem, Inc.1989-12-05
TRU-TOUCH VINYL, STERILE (K892327)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-05
ECG SIMULATOR MODEL ECGPLUS (K893660)Bio-Tek Instruments, Inc.1989-12-05
SYNCHRON CX SYSTEMS (LAP) REAGENT KIT (K895850)Beckman Instruments, Inc.1989-12-05
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS (K892926)Vas-Cath, Inc.1989-12-05
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM (K891121)Boston Scientific Corp1989-12-05
TAGUM LATEX EXAMINATION GLOVES (K892073)Tagum Rubber Industries, Ltd.1989-12-05
IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P (K894748)Singer Medical Products, Inc.1989-12-05
IMPEDANCE ANALYZER MODELS MD-2, MD-P (K895783)Singer Medical Products, Inc.1989-12-05
LATEX PATIENT EXAMINATION GLOVES (K895642)Siam Sempermed Corp., Ltd.1989-12-05
FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES (K892328)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-05
IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 (K895784)Singer Medical Products, Inc.1989-12-05
NON-STERILE LATEX EXAMINATION GLOVES (K896220)Allstar Sdn. Bhd.1989-12-05
TRU-TOUCH VINYL, NON-STERILE (K891719)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-05
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Track 1989 automatically

Every clearance here is in the API, with alerts when new ones post.