Atlas FDA

1989

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

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RecordFirmDate
TECNOL SILK STRIP (K894205)Tecnol New Jersey Wound Care, Inc.1989-07-25
LYME DISEASE MICROASSAY (K890843)Diamedix Corp.1989-07-25
NEW WEST SUNGLASSES (K893986)New West Promotions1989-07-25
GENETIC SYSTEMS MICROPLATE READER (K891767)Genetic Systems Corp.1989-07-25
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (K894364)Kronus1989-07-25
MINICLINIC PREGNANCY TEST (K894012)Vanguard Biomedical Corp.1989-07-25
WORLD CHAIR (K894136)Invacare Corp.1989-07-25
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS (K893815)Hycor Biomedical, Inc.1989-07-25
THE FERN CRYOPROBE (K892237)Cryogenic Instruments & Equipment , Ltd.1989-07-25
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II (K893970)Analytical Control Systems, Inc.1989-07-25
HDL PRECIPITATING REAGENT (K893966)Diagnostic Systems1989-07-25
M.F.S. LOW AIR LOSS PULSATING BED (K893801)Medical Flotation Systems, Inc.1989-07-25
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II (K893971)Analytical Control Systems, Inc.1989-07-25
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 (K893128)Stanbio Laboratory1989-07-25
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE (K893835)Ciba Corning Diagnostics Corp.1989-07-25
SIEMENS CEILING STAND 800F, 800 AND 810 (K891023)Siemens Medical Electronics1989-07-25
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL (K893895)Intercare Diagnostics, Inc.1989-07-25
P.S.A. FEMORAL HIP PROSTHESIS (K893959)Protek, Inc.1989-07-25
MODIFIED POLYCHROME IV STAIN (K894045)Devetec, Inc.1989-07-25
TWO TANK DISSOLUTION MODULE (K893612)National Medical Care, Medical Products Div., Inc.1989-07-24
THORACENTISIS KIT (K894326)Mill-Rose Laboratory1989-07-24
KENDALL CURITY EXTENSION TUBES (K892440)The Kendal Co.1989-07-24
ENTERA-FLO SPIKE SET (K893209)Delmed, Inc.1989-07-24
MODIFIED DEMAND NASAL OXYGEN CANNULA (K892407)Salter Labs1989-07-24
PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET (K890093)Kells Medical, Inc.1989-07-24
SHUNT CONNECTORS (K893679)Akcess Medical Products, Inc.1989-07-24
LATEX EXAMINATION GLOVES (K893296)Midas Intl. Development Corp.1989-07-24
ANGIOGRAPHY CUSTOM PACKS (K891572)Procedure Packs, Inc.1989-07-24
KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (K892438)The Kendal Co.1989-07-24
DISPOSABLE MEDICAL GOWNS (K891820)Bioshield, Inc.1989-07-24
NEOVO2R VENTILATORY (K885243)Neomed1989-07-24
PERITONEAL DIALYSIS SYSTEM AND ACCESS. (K893712)Delmed, Inc.1989-07-24
LATEX EXAMINATION GLOVES (K893864)In Medicine, Inc.1989-07-24
MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA (K892406)Salter Labs1989-07-24
LATEX EXAMINATION GLOVES (K893295)Lee AH Sheng Ent. Co., Ltd.1989-07-24
M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ (K892355)Hewlett-Packard Co.1989-07-24
ML-800 AUTOELECTRONIC LIGHT SOURCE (K893828)M.P. Video, Inc.1989-07-24
FILTRAL TM 20 HEMODIALYZER/FILTER (K893742)Hospal Medical Corp.1989-07-24
HOLLOW FIBER DIALYZER FOCUS 70H (K893677)National Medical Care, Medical Products Div., Inc.1989-07-24
VINYL PATIENT EXAMINATION GLOVES (K892575)Foodhandler, Inc.1989-07-24
SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE (K892845)Philips Medical Systems, Inc.1989-07-20
ACID PHOSPHATASE REAGENT (K892393)Medical Analysis Systems, Inc.1989-07-20
MINICLINIC OVULATION PREDICTION TEST (K891762)Vanguard Biomedical Corp.1989-07-20
PANCREATIC A-AMYLASE PNP (K892848)Boehringer Mannheim Corp.1989-07-20
1 VIDEO TAPE RECORDER MODEL BK-224 H (K892934)Perkins Mfg. Co.1989-07-20
RMS 180 (K893673)Fischer Imaging Corp.1989-07-20
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP (K893409)Yellow Springs Instrument Co., Inc.1989-07-20
DADE LIPID-TROL (K893580)Baxter Healthcare Corp1989-07-20
SUPER SPEED POTTER-BUCKY (ESO5-110 & 220) (K893690)Hofmann X-Ray of America, Inc.1989-07-20
J&S IRON SATURATING REAGENTS (K893662)J.S. Medical Assoc.1989-07-20
14 COLOR VIDEO DISPLAY 211-260-010 (K893585)Mennen Medical, Inc.1989-07-20
CENTRICON CONCENTRATOR (K893733)Amicon, Inc.1989-07-20
SHILEY SPECIALIZED TRACHEOSTOMY TUBE (K890194)Shiley, Inc.1989-07-20
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE (K892500)Ciba Corning Diagnostics Corp.1989-07-20
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 (K893752)Em Diagnostic Systems, Inc.1989-07-20
TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES (K892929)Technicon Instruments Corp.1989-07-20
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS (K892668)Catachem, Inc.1989-07-20
THE POUCH GROIN & ABDOMINAL STRESS AID (K892379)Kuhn Industries1989-07-20
MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM (K893637)Shimadzu Medical Systems1989-07-20
STAT CHEM SYSTEM (K891050)Diagnostic Resources, Inc.1989-07-20
VISION INTEGRATED PERFORMANCE OPTION (K893689)Siemens Medical Solutions USA, Inc.1989-07-20
ALT REAGENT (PROCEDURE NUMBER 159) (K893560)Sigma Chemical Co.1989-07-20
RME 325R (K893674)Fischer Imaging Corp.1989-07-20
COBAS FARA CENTRIFUGAL ANALYZER (K893641)Roche Diagnostic Systems, Inc.1989-07-20
MAMM-AIRE CP (K893681)Custom Medical Products, Ltd.1989-07-20
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 (K893765)Em Diagnostic Systems, Inc.1989-07-20
BIAD NUCLEAR IMAGING SYSTEM (K892875)Trionix Research Laboratory, Inc.1989-07-20
REP(TM) CK-2 STAT KIT, CAT. NO. 3074 (K893007)Helena Laboratories1989-07-20
2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR (K894053)Fenem, Inc.1989-07-20
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER (K892410)Baxter Healthcare Corp1989-07-20
70-X/RVG (RADIOVISIOGRAPHY) (K881133)Trophy Radiologie1989-07-20
DOCUMENT(TM) URIC ACID LINEARITY TEST SET (K893139)Casco Standards1989-07-20
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME (K893269)Beckman Instruments, Inc.1989-07-20
ULCERCARE (K892867)Jobst Institute, Inc.1989-07-20
SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 (K890963)Esaote Biomedica Elettronica1989-07-19
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (K892059)Protek, Inc.1989-07-19
POROUS GENESIS STEMMED TIBIAL COMPONENT (K892366)Richards Medical Co., Inc.1989-07-19
POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. (K890132)Richards Medical Co., Inc.1989-07-19
CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM (K893042)Endosonics Corp.1989-07-19
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 (K892944)Interspec, Inc.1989-07-19
P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS (K892394)Johnson & Johnson Professionals, Inc.1989-07-19
BIOPSY KIT (K892389)I M, Inc.1989-07-17
LAPAROSCOPIC SUCTION PROBE (K893527)Dexide, Inc.1989-07-14
J1 ATTACHMENT (ORTHODONTIC APPLIANCE) (K891982)T.M.K. Dental Products1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892749)Industri Leva Sdn. Bhd.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892122)Wallgear Industrial Ltd. C/O Condor Financial1989-07-14
MOBILE C-ARM (K893617)Acoma Medical Imaging, Inc.1989-07-14
LATEX EXAM GLOVES (K893241)Semodal Jaya Sdn. Bhd.1989-07-14
PATIENT EXAM GLOVES (MFG. MOSS POINT GLOVE CO.) (K891940)Tillotson Corp.1989-07-14
VINYL EXAMINATION GLOVES (K891840)Maxcare, Inc.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892588)Dynamic Plantations Sdn Bhd1989-07-14
CARDIOCAP(TM) DR-104 REPORTER (K885058)Datex Division Instrumentarium Corp.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892271)Asma Rubber Products Pvt. , Ltd.1989-07-14
LATEX PATIENT EXAMINATION GLOVES (K891110)I Horng Industrial Co., Ltd.1989-07-14
ALAMTEX PATIENT EXAMINATION GLOVES (LATEX) (K891966)Concept Rubber Products Sdn Bhd1989-07-14
CHAMP-PAQ LATEX PATIENT EXAM GLOVES (K892097)Winmed Instruments Mfg. Corp.1989-07-14
LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) (K890891)Interpro Intl., Inc.1989-07-14
PATIENT EXAMINATION GLOVES (K891284)Real Latex Pvt. , Ltd.1989-07-14
TOXO ELISA TEST SYSTEM (K891781)Zeus Scientific, Inc.1989-07-14
ANATOMICAL EXAMINATION GLOVES (K892579)Ansell Pacific, Inc.1989-07-14
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