Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TRACET AG 4000 (K904512)Lectec Corp.1991-01-31
FLEXIBLE ENDOSCOPIC ELECTRODE (K905731)Applied Urology, Inc.1991-01-31
FLOWERS CHIN IMPLANT (K905267)Implantech Associates, Inc.1991-01-31
INTRAUTERINE CATHETER SET (K905812)Epcom Medical Systems, Inc.1991-01-31
AUTO FIRST-AID KIT FOR AMERICA (K903393)Hisler-Radke, Inc.1991-01-31
IODOSORB GEL (K905069)Perstorp AB C/O Robert Joel Slomoff1991-01-31
ELMED PNEUMOMAT DIGITAL (K905417)Elmed, Inc.1991-01-31
FLOWERS JOWL IMPLANT (K905268)Implantech Associates, Inc.1991-01-31
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (K910029)Spacelabs, Inc.1991-01-31
SURGICARE STERILE SURGICAL GLOVES (K904972)Kanam Latex Industries Pvt. , Ltd.1991-01-31
ORAL PHARYNGEAL CLEANSING DEVICE (K905011)Concord/Portex1991-01-31
DIGIGRAPH DIAGNOSTIC WORK/STATION (K896099)Dolphin Imaging Systems1991-01-31
FLEXIFLO STOMATE EXTENSION TUBE (K902623)Abbott Laboratories1991-01-31
MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER (K905080)Kendall Healthcare Products Co. Div.Of Tyco Health1991-01-31
PC-BEADS POSTCOITAL TEST (K902995)Microscopy Research Innovations1991-01-31
WALLACH FLEXIBLE ENDOMETRIAL SAMPLER (K902693)Wallach Surgical Devices, Inc.1991-01-31
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 (K905661)Em Diagnostic Systems, Inc.1991-01-31
VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) (K903847)Zest Mark Industrial Co., Ltd.1991-01-31
PEGASUS WITH ACCESSORIES (K905082)Pfizer Laser Systems1991-01-31
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE (K905440)United States Surgical, A Division of Tyco Healthc1991-01-31
UBI MAGIWEL CORTISOL QUANTITATIVE (K905473)United Biotech, Inc.1991-01-31
SIL-MED T-TUBE DRAIN (K903989)Sil-Med Corp.1991-01-31
JAIN SUTURE/VESIBAND ORGANIZER (K905105)Jain Surgical Equipment, Inc.1991-01-31
IMMULITE HS-TSH (K905769)Cirrus Diagnostics, Inc.1991-01-31
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (K905000)Corometrics Medical Systems, Inc.1991-01-31
UST-969-5 CONVEX TRANSDUCER (K905391)Ge Medical Systems Information Technologies1991-01-31
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER (K905106)United States Surgical, A Division of Tyco Healthc1991-01-31
ACE 3.5MM CORTICAL BONE SCREW (K905048)Ace Medical Co.1991-01-30
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE (K910075)Diagnostic Products Corp.1991-01-30
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (K905649)Biochemical Trade, Inc.1991-01-30
MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY (K904983)Meadox Surgimed, Inc.1991-01-30
RESPIRONICS BIPAP REMOTE CONTROL UNIT (K905540)Respironics, Inc.1991-01-30
PHILIPS MULTILEAF COLLIMATOR (MLC) (K904124)Philips Medical Systems, Inc.1991-01-30
TOTAL HIP FEMORAL COMPONENT (K905260)Intermedics Orthopedics1991-01-30
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE (K904947)Planmeca USA, Inc.1991-01-30
MODEL #250 DEFIB CABLE (K904466)Cardiotronics, Inc.1991-01-30
PM2002 CC AND PM2002 EC (K904948)Planmeca USA, Inc.1991-01-30
STAT(TM) GLOVE (K905177)Success Builders Intl., Inc.1991-01-30
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT (K905777)Immunotech Corp.1991-01-30
LEAD STYLET (K905674)Cardiac Pacemakers, Inc.1991-01-30
LATEX GLOVE APPLICATION AND REMOVAL SYSTEM (K905127)Success Builders Intl., Inc.1991-01-30
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K905773)Mallinckrodt Medical1991-01-30
MERISTAR-MP (K905493)Meridian Diagnostics, Inc.1991-01-30
FLEXERCYCLE (K904823)Medmetric Corp.1991-01-30
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION (K905432)Datascope Corp.1991-01-30
MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER (K904409)Medtronic Vascular1991-01-30
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS (K905829)Kamiya Biomedical Co.1991-01-30
FUKUDA DENSHI MODEL LX-3100 (K903514)Fukuda Denshi USA, Inc.1991-01-30
LU-TEX II (K904535)Lukens Medical Corp.1991-01-30
BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) (K905189)Baxter Healthcare Corp1991-01-30
ADULT STAR, MODIFICATION (K905272)Infrasonics Corp.1991-01-30
DANNIFLEX MODEL 500TM CPM (K904735)Buckman Co., Inc.1991-01-30
TITANIUM COC ABUTMENT HEADS FOR IMZ (K904605)Implant Support Systems, Inc.1991-01-29
AM130 AGC-O (BEHIND THE EAR) HEARING AID (K910148)Electone, Inc.1991-01-29
ACOUSTIQ LISTENING DEVICE (K904755)Krueger Laboratories1991-01-29
ELECTONE BTE MODEL AM 130 PP (K910101)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM 240 HF (K910099)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM 130 D (K910100)Electone, Inc.1991-01-29
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP. (K905761)Argen Precious Metals, Inc.1991-01-29
CEROS 80 (HA) (K900136)Mathys Corp.1991-01-29
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* (K904931)United States Surgical, A Division of Tyco Healthc1991-01-29
ELECTONE BTE MODEL AM 240 PPL (K910102)Electone, Inc.1991-01-29
DEVICE PART NUMBER DPI-1106 IMPLANT (K902928)Minimatic Implant Technology1991-01-29
FETAL MONITORING SPIRAL ELECTRODE (K905130)Graphic Controls Corp.1991-01-29
ELECTONE BTE MODEL AM900 PP (K910096)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM 130 HF (K910103)Electone, Inc.1991-01-29
ARGENCO 52HN (K905811)Argen Precious Metals, Inc.1991-01-29
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (K904745)Graphic Controls Corp.1991-01-29
DIAGNOSTIC ULTRASOUND VERSADOPP 1000 (K904792)Diagnostic Ultrasound Corp.1991-01-28
GROMMET STYLE VENTURI (K904597)River Medical, Inc.1991-01-28
FULL VIEW OMEGA TABLE (K905827)Med-Tron Products, Inc.1991-01-28
DYNATECH MR4000 MICROPLATE READER (K904567)Dynatech Corp.1991-01-28
BEUCHEL-PAPPAS GLENOID COMPONENT (K904879)Endotec, Inc.1991-01-28
BUECHEL-PAPPAS HUMERAL STEM COMPONENT (K904880)Endotec, Inc.1991-01-28
I/A VITROPHAGE MODEL YPR 2001 (K904909)Visioncare Devices, Inc.1991-01-28
HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL (K904967)Gambro-Hosp-Cobe, Inc.1991-01-28
NMR-K FUNDUS LASER LENS (K910231)Ocular Instruments, Inc.1991-01-28
HALA'TUS 1 OXYGENATOR (K903504)The Henry G. Dietz Co., Inc.1991-01-28
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS (K901853)Johnson & Johnson Medical, Inc.1991-01-28
RAPITEX(R) ASL NEW (K903854)Behring Diagnostics, Inc.1991-01-28
143 SERIES BTE (K905692)Gn Danavox, Inc.1991-01-28
SEROMA-CATH CLOSE DRAINAGE SYSTEM (K905733)Dawn Medical1991-01-28
SENSITOUCH (K904769)Ansell Intl.1991-01-28
TRU-TOUCH POWDER FREE (K905503)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-01-28
133 SERIES BTE (K905679)Gn Danavox, Inc.1991-01-28
PATIENT EXAMINATION GLOVES (K905172)Tessile, Inc.1991-01-28
COLLAR BUTTON STYLE VENTURI (K904594)River Medical, Inc.1991-01-28
ELECTONE BTE MODEL AM 240 PPI (K910098)Electone, Inc.1991-01-28
SLIDEX STREPTO-KIT (K905020)Vitek Systems, Inc.1991-01-28
FUNKY SUNGLASS (K904981)Monogram International,Inc.1991-01-28
BOBBIN STYLE VENTURI (K904592)River Medical, Inc.1991-01-28
OSTEONICS(R) MPSS HIP STEM SERIES (K905275)Osteonics Corp.1991-01-28
THAYER MIP ADAPTER (K904917)Thayer Medical Corp.1991-01-28
BODYLOG ENHANCED STRESS REDUCTION PACKAGE (K902450)Bodylog, Inc.1991-01-25
RHEUMAGEN ASO T-CONTROL (K904311)Biokit USA, Inc.1991-01-25
COULTER DART ALT (GPT) REAGENT (K905767)Coulter Electronics, Inc.1991-01-25
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM (K904911)Fiber Delivery Concepts, Inc.1991-01-25
NEUROMED MODEL 1992 LS LAMITRODE LEAD (K905255)Neuromed, Inc.1991-01-25
COAG-1 PT-NC TEST CARD (K904325)Cardiovascular Diagnostic Services1991-01-25
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES (K905111)Eigen1991-01-25
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Track 1991 automatically

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