Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SANASSAY IC TEST (K860996)Scientific Sales Intl., Inc.1987-03-30
VWF IMMUNOBLOT (K864701)Ramco Laboratories, Inc.1987-03-30
MEDIUM 199 WITH EARLE'S SALTS PRODUCT NO. M2520 (K870530)Sigma Chemical Co.1987-03-30
'EXMOOR' ZOELLNER SUCKER ENDS (K864937)Exmoor Plastics , Ltd.1987-03-30
BGJB MED(FITTON JACKSON MOD)W/L-GLUT/W/O SOD BICAR (K870497)Sigma Chemical Co.1987-03-30
MCCOY 5A MED (MOD) SUUSPENSION CULTURE, M6523 (K870499)Sigma Chemical Co.1987-03-30
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE (K864219)Amedic USA1987-03-27
POWDERED BICARBONATE CONCENTRATE (K865078)Bicarbolyte Corp.1987-03-27
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 (K870728)A&D Engineering, Inc.1987-03-27
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE (K864908)Diasonics, Inc.1987-03-27
PHARMASEAL WOUND CARE DRESSING PAD (K870941)American Pharmaseal Div. Ahsc1987-03-27
CAPILLARY FLOW HOLLOW FIBER DIALYZERS (K863044)National Medical Care, Medical Products Div., Inc.1987-03-27
COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS (K864831)Cobe Laboratories, Inc.1987-03-27
280SL IMAGING SYSTEM TRANVAGINAL PROBES (K864151)Ge Medical Systems Information Technologies1987-03-27
MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR (K864261)Bio-Dyne, Inc.1987-03-27
BIOPSY NEEDLE GUIDE ATTACHMENT (K863797)Elscint, Inc.1987-03-27
ADULT APNEA MONITOR (20), MONITOR INTERFACE (30) (K870835)Applied Membrane Technology, Inc.1987-03-27
ACUSON TV519 TRANSDUCER (K864578)Acuson Computed Sonography1987-03-27
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET (K870704)American Pharmaseal Div. Ahsc1987-03-27
7.5 MHZ ENDOVAGINAL PROBE (K870709)Philips Ultrasound, Inc.1987-03-27
MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM) (K870255)Transcor, Inc.1987-03-26
NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 (K870806)United Surgical Corp.1987-03-26
BIO-VENT REUTER BOBBIN TUBE (K870877)Richards Medical Co., Inc.1987-03-26
OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 (K864466)Omron Tateisi Electronics Co.1987-03-26
INTRAMEDULLARY NAIL (K870040)The Deca Co.1987-03-26
ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE (K870775)Entravision, Inc.1987-03-26
MEDSURG CHIBA PTC NEEDLE (K870893)Medsurg Industries, Inc.1987-03-25
VP2000 INFUSION PUMP (K870279)Vickers , Ltd.1987-03-25
ALADIN (TM) (K865062)Analytical Products, Inc.1987-03-25
IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (K870029)American Micro Scan1987-03-25
URINE METER, 250CC (K871042)Salt Creek Medical Technologies1987-03-25
VAN-TEC PROSTATE BIOPSY NEEDLE (K870698)Van-Tec, Inc.1987-03-25
BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 (K870300)Belmont Equipment Corp.1987-03-25
INSTANT HEAT COMPRESS, CHEMICAL TYPE (K871114)Lexington Industries1987-03-25
AGAR 7K TENS INSTRUMENT (K862454)Solcoor, Inc.1987-03-25
CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW (K871037)Concept, Inc.1987-03-25
EDCOOL AND EDCOOL JR. INSTANT COLD PACK (K871006)Advantage Credit Services, Inc.1987-03-25
VAN-TEC DOUBLE SHEATH GRASPING FORCEPS (K865087)Van-Tec, Inc.1987-03-25
KAMINSKY COMBINATION STENT & INJECTION CATHETER (K865085)Van-Tec, Inc.1987-03-25
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES (K862632)Zimmer, Inc.1987-03-25
CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD (K871012)Cropper Medical, Inc.1987-03-25
GUIDE WIRE (K870664)Datascope Corp.1987-03-25
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (K864662)American Micro Scan1987-03-25
PROSTATIC ASPIRATION BIOPSY SET (K870735)Van-Tec, Inc.1987-03-25
MSI HEMATOLOGY CONTROL + (K871067)Medical Specialties, Inc.1987-03-25
DD-VCR-64 (K870381)Grass-Telefactor Product Group1987-03-25
VAN-TEC POSITIVE OPEN SEGURA BASKET (K870615)Van-Tec, Inc.1987-03-25
DS-DNA EIA DIAGNOSTIC KIT (K870453)Biohytech International, Inc.1987-03-24
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (K870467)Hyclone Laboratories, Inc.1987-03-24
TINA-QUANT(R) (A) C4 (K870931)Boehringer Mannheim Corp.1987-03-24
CHARACTERIZED FETAL BOVINE SERUM #A-1115 (K870464)Hyclone Laboratories, Inc.1987-03-24
MODEL 102 PH METER (K870811)Mesa Medical, Inc.1987-03-24
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES (K870994)Roche Diagnostic Systems, Inc.1987-03-24
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K870564)Atlantic Antibodies1987-03-24
TINA-QUANT(R) (A) C3 (K870930)Boehringer Mannheim Corp.1987-03-24
OPTI-FIX ACETABULAR COMPONENT (K864857)Richards Medical Co., Inc.1987-03-24
ADULT BOVINE SERUM (K870468)Hyclone Laboratories, Inc.1987-03-24
DEFINED FETAL BOVINE SERUM #A-1111 (K870463)Hyclone Laboratories, Inc.1987-03-24
AUTO ENTRY SYSTEM (MATE) (K870425)Kg Engineering, Inc.1987-03-24
DEFINED CALF BOVINE SERUM #A-2111 (K870466)Hyclone Laboratories, Inc.1987-03-24
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL (K870862)Atlantic Antibodies1987-03-24
6/40 FETAL BOVINE SERUM #A-1110 (K870465)Hyclone Laboratories, Inc.1987-03-24
FUKUDA DENSHI MODEL FCP-15 (K871025)Fukuda Denshi USA, Inc.1987-03-24
DEFINED EQUINE SERUM #A-3311 (K870469)Hyclone Laboratories, Inc.1987-03-24
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY (K870624)Ventrex Laboratories, Inc.1987-03-24
MODIFIED DRAGER SPHYGMOMED (K862427)Draeger Medical, Inc.1987-03-23
COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE (K863424)Micromedical Technologies, Inc.1987-03-23
'EXMOOR' T-TUBE (K871035)Exmoor Plastics , Ltd.1987-03-23
CASSETTE TAPE REPLAY SYSTEM (K870554)Research Instrumentation Associates, Inc.1987-03-23
ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. (K870826)Shiley, Inc.1987-03-23
MT8 BIOLOGICAL TELEMETRY SYSTEM (K870901)Oxford Metrics, Inc.1987-03-23
'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR (K864938)Exmoor Plastics , Ltd.1987-03-23
45 DEGREE SHAVER (K870882)Bowen & Company, Inc.1987-03-23
S.C.M.T. PERFORATOR (K871087)Salt Creek Medical Technologies1987-03-23
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC (K870663)Analytical Products, Inc.1987-03-23
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12 (K863708)Siemens Medical Solutions USA, Inc.1987-03-23
SCMT UMBILICAL CLAMP (K871075)Salt Creek Medical Technologies1987-03-23
HEART TRACK (K864293)Cardio Telemetric Systems, Inc.1987-03-23
NEW MODEL STYLES FOR AORTIC ARCH CANNULA (K870825)Shiley, Inc.1987-03-23
WINPETTE (K871076)Ulster Scientific, Inc.1987-03-23
DISCIPLINE I (K870872)Physio Systems, Inc.1987-03-23
TDK ECG ELECTRODE MEL-10 (K870834)Tdk Corp.1987-03-23
LOOSE BODY GRASPERS (K870881)Bowen & Company, Inc.1987-03-23
TIP, DENTAL SUCTION APPARATUS (K870599)Military Engineering, Inc.1987-03-23
SATLITE/PB251 PULSE OXIMETER (K870621)Datex Division Instrumentarium Corp.1987-03-20
THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM (K864318)The Buddy Systems, Inc.1987-03-20
EMIT NORTRIPTYLINE ASSAY (K870823)Syva Co.1987-03-20
HEARTECH HFX, HEARING AID (K870723)Hearing Tech, Inc.1987-03-20
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS (K870216)Osteonics Corp.1987-03-20
PM-8 HEART RATE MONITOR (K864748)Pulse Time Products, Ltd.1987-03-20
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR (K870851)Electromed Intl., Ltd.1987-03-20
STERILE PROCEDURAL TRAYS (K870373)Dimed, Intl.1987-03-20
THREADED ACETABULAR COMPONENT (K870445)Johnson & Johnson Professionals, Inc.1987-03-20
CARDIAN III CR6A (K864704)Cardiac Recorders, Ltd.1987-03-20
LOOK RETROBULBAR NEEDLES (K870902)Look, Inc.1987-03-20
SHELF LIFE CHANGE OF STERILE DEVICES (K864090)Utah Medical Products, Inc.1987-03-20
CARDIOVIT AT-6 (K864465)Schiller Corp.1987-03-20
P.T.H. METAL-BACKED ACETABULAR CUP (K870234)Orthopaedic Device Corp.1987-03-20
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE (K870610)Telectronics, Inc.1987-03-20
KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM (K864924)Kirschner Medical Corp.1987-03-20
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Every clearance here is in the API, with alerts when new ones post.