Atlas FDA

1989

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

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RecordFirmDate
DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 (K894131)Thermedics, Inc.1989-09-26
DANTEX VINYL EXAMINATION GLOVES (K894488)Dan Co., Ltd.1989-09-26
LATEX PATIENT EXAMINATION GLOVE (K894796)Bh Limela Industries Sdn. Bhd.1989-09-26
ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER (K892851)Johnson & Johnson Patient Care, Inc.1989-09-26
SILICONE FLOW-DIRECTED THERMODILUTION CATHETER (K893435)Cathlab Corp.1989-09-26
KUT-SHIELD (K895092)Kut-Guard, Inc.1989-09-26
ESCORT PULSE OXIMETRY OPTION (K892120)Medical Data Electronics1989-09-26
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS (K895495)Medtronic Vascular1989-09-26
VINYL EXAMINATION GLOVES (K891513)Mann Chi Trading Co., Ltd.1989-09-26
LATEX EXAMINATION GLOVES (K894616)World Wide EX Im, Inc.1989-09-26
SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER (K894539)Toa Medical Electronics USA, Inc.1989-09-26
SURE-TEC LATEX EXAMINATION GLOVES (K894739)All American Poly of Pennsylvania Corp.1989-09-26
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME (K894277)Hewlett-Packard Co.1989-09-26
CN GLOVES (K893749)C.N. Technocrats1989-09-26
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER (K894942)Boston Scientific Corp1989-09-26
RAPIDEC UR (K894805)Dms Products, Inc.1989-09-26
PATIENT EXAMINATION GLOVES (LATEX) (K892760)Saha Import & Export Co.1989-09-26
MAESTRO PACEMAKER TEST MAGNET (K895110)Cardiac Control Systems, Inc.1989-09-26
MEDPRIDE LATEX SURGEONS GLOVES (K895027)Medpride1989-09-26
FLEXMEDICS GUIDEWIRE (K893626)Flexmedics1989-09-26
LATEX PATIENT EXAMINATION GLOVES (K895536)Perfect Latex Pvt. , Ltd.1989-09-26
PATIENT EXAMINATION GLOVES, LATEX (K894454)Windwell Agencies Sdn. Bhd.1989-09-26
CERAMIC FEMORAL HEAD (K893685)Dow Corning Wright1989-09-26
FPR DIGOXIN KIT (K894521)Colony Laboratories, Inc.1989-09-25
ABBOTT SPECTRUM(R) CALCIUM REAGENT (K894407)Abbott Laboratories1989-09-25
COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS (K895143)Lumenis, Inc.1989-09-25
NTI-1000 (K894097)Neurotek, Inc.1989-09-25
SERIES 3 GENERAL SUCTION SYSTEM (K891129)Ultravac, Inc.1989-09-25
FPR PHENYTOIN CALIBRATOR KIT (K894528)Colony Laboratories, Inc.1989-09-25
FPR PHENYTOIN KIT (K894527)Colony Laboratories, Inc.1989-09-25
ACTIDERM (TM) DERMATOLOGICAL PATCH (K895376)Convatec, A Division of E.R. Squibb & Sons1989-09-25
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM (K892895)Everest Medical Corp.1989-09-25
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II (K895210)Abbott Laboratories1989-09-25
QUICK CHANGE MONTGOMERY STRAP (K893569)Med-Dex Intl.1989-09-25
FREE T3 RADIOIMMUNOASSAY KIT (K894200)Advanced Magnetics, Inc.1989-09-25
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (K885220)Ethox Corp.1989-09-25
FPR DIGOXIN CALIBRATOR KIT (K894522)Colony Laboratories, Inc.1989-09-25
PREMISE SERIES BED (K894296)Batesville American Mfg. Co.1989-09-22
16 GA X 10 BULLET POINT NEEDLE (K894873)R. J. Doyle, Inc.1989-09-22
20GA X 7-1/2 THREADING BULLET POINT NEEDLE (K894875)R. J. Doyle, Inc.1989-09-22
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS (K894413)Inmark Corp.1989-09-22
THE INDEPENDENT CARE UNIT (K893745)The Water Carriage Co., Inc.1989-09-22
REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM (K894299)Repro-Med Systems, Inc.1989-09-22
SERVO ANESTHESIA CIRCLE 985 (K893786)Siemens Life Support Systems1989-09-22
14 INCH BULLET POINT NEEDLE (K894874)R. J. Doyle, Inc.1989-09-22
VVR/Q CALORIMETER (K895586)Vita-Stat1989-09-22
16 GA X 6 BULLET POINT NEEDLE (K894872)R. J. Doyle, Inc.1989-09-22
COIL AND COIL DELIVERY SYSTEM (K891688)Target Therapeutics1989-09-22
PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE) (K892670)Physio-Dyne Instrument Corp.1989-09-22
MODIFIED MEMORY RETRACTOR ARM (K895537)Medical Equipment Development Co., Inc.1989-09-22
SHIMADZU X-RAY TUBE STAND FH-31 (K895188)Shimadzu Medical Systems1989-09-22
HOLTAIN BODY COMPOSITION ANALYSER (K891928)Seritex, Inc.1989-09-22
MODIFIED HAM'S F-10 W/ALBUMIN (K894432)Irvine Scientific1989-09-22
NATIONAL MEDICAL CARE VENOUS LINE 03-9548 (K894637)National Medical Care, Medical Products Div., Inc.1989-09-22
AMADEUS VENTILATOR (K894316)Hamilton Medical, Inc.1989-09-22
HTF WITH ALBUMIN (CATALOG NO. 9994) (K894405)Irvine Scientific1989-09-22
FLEX EYEWEAR FRAMES (K895371)Flex Eyewear, Inc.1989-09-21
PATIENT EXAM GLOVES (MFG: GLOVES INT'L LTD.) (K894178)Lanka Products, Inc.1989-09-21
LASERMED* GOGGLES AND SPECTACLES (K894835)Glendale Protective Technologies, Inc.1989-09-21
MULTIPLE MENTAL SPECTACLE FRAMES (K895300)Optica Trade S.A.1989-09-21
PATIENT EXAMINATION GLOVES (K894196)Lanka Products, Inc.1989-09-21
CUSIS ULTRASOUND SKIN IMAGING SYSTEM (K893996)Stiefel Research Institute, Inc.1989-09-21
VISTA STREAK RETINOSCOPE (AC-POWERED) (K893171)Keeler Instruments, Inc.1989-09-21
LATEX EXAMINATION GLOVES (K893882)Sinochem (Usa), Inc.1989-09-21
QM300 CERULOPLASMIN ANTIBODY PACK (K895377)Kallestad Diag, A Div. of Erbamont, Inc.1989-09-21
ARMOR, LATEX EXAMINATION GLOVES (K894499)Prestige Manufacturing Snd Bhd1989-09-21
LATEX PATIENT EXAMINATION GLOVES (K894696)Sun Holy Manufactory , Ltd.1989-09-21
PATIENT EXAMINATION GLOVES (K892921)Millimax Corp.1989-09-21
RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE (K894019)Resound Corp.1989-09-21
PROGENE IGE BEAD EIA (K895294)Progene Corp.1989-09-21
PATIENT EXAMINATION GLOVE (LATEX) (K892077)Forchic Corp. of USA1989-09-21
ADG BONE BIOPSY SYSTEM (K890722)American Design Group, Inc.1989-09-21
VINYL EXAM GLOVES (K893271)Consul Chemical Industry Corp.1989-09-21
ANA ANTISERA CONTROL KIT (K894659)Lipogen, Inc.1989-09-21
LATEX EXAMINATION GLOVES (K894386)Ningbo Yujiang Plastic & Rubber Co. , Ltd.1989-09-21
GLOBE PATIENT EXAMINATION GLOVES (K893000)Lucky and Happy, Inc.1989-09-21
LATEX EXAMINATION GLOVES (K894080)Shanghai Intl. Corp.1989-09-21
IFA SENSIBAC NORFLOXACIN (K892728)Investigacion Farmaceutica S.A. DE C.V.1989-09-21
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II (K894103)Scimed Life Systems, Inc.1989-09-21
PATIENT EXAMINATION GLOVES (LATEX) (K891429)Wei Ming Industry Co. , Ltd.1989-09-21
ANTELOPE BRAND PATIENT EXAMINATION GLOVES (K892781)Liaoning-Usa Corp.1989-09-21
PATIENT EXAMINATION GLOVES (LATEX) (K892556)Fabella Industries Sdn Bhd1989-09-21
PATIENT EXAMINATION GLOVES (K894375)Pan-Century Rubber Products Sdn. Bhd.1989-09-21
MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE (K894981)Medtronic Vascular1989-09-20
9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON (K892798)Kontron Instruments, Inc.1989-09-20
8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON (K892799)Kontron Instruments, Inc.1989-09-20
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE) (K893459)Medtronic Vascular1989-09-20
OPUS MODELS 4033 AND 4034 (K894267)Ela Medical, Inc.1989-09-20
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON (K892797)Kontron Instruments, Inc.1989-09-20
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES (K894801)Advance Medical Designs, Inc.1989-09-19
DISPOSABLE LATEX EXAMINATION GLOVES (K893767)Masif Healthcare Products Sdn. Bhd.1989-09-19
PVS DUAL CURE VENEER BONDING KIT (K894391)Jelenko Co.1989-09-19
PERRY* STERILE X-AM* GLOVES (K891444)Smith & Nephew Medical1989-09-19
VARIOUS DISPOSABLE SURGICAL GARMENTS (K895235)Protect Corp. of Indiana, Inc.1989-09-19
TERUFUSION THREE WAY STOPCOCK (K891234)Terumo Medical Corp.1989-09-19
RMI ARTERIAL PERFUSION CANNULA (K894243)Research Medical, Inc.1989-09-19
MEDI-TRACE ACCU-NATE DEVICE (K891193)Graphic Controls Corp.1989-09-19
MAXIMUM CURE SEALANT WITH FLUORIDE (K894566)Reliance Orthodontic Products, Inc.1989-09-19
MITEK ANCHOR (K892126)Mitek Surgical Products, Inc.1989-09-19
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM (K894609)Mardx, Inc.1989-09-19
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Every clearance here is in the API, with alerts when new ones post.