Atlas FDA

1991

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

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RecordFirmDate
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT (K904282)W. L. Gore & Associates, Inc.1991-01-16
AUTOWAND(TM) 7XXX SERIES, MODIFICATION (K904888)Boehringer Laboratories1991-01-16
IPG-II MODULE (K903700)Life Sciences Manufacturing, Inc.1991-01-16
RHEOLOGIC I (K903711)Advanced Rehabilitative Technology, Inc.1991-01-16
F.T.I. MEDICAL LIGHT GUIDE (K904378)Fiberoptics Technology, Inc.1991-01-16
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 (K904965)Smith & Nephew Equipment Group1991-01-16
ECLIPSE ICA BUN (K905602)Biotope, Inc.1991-01-16
HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR (K905393)Frigitronics, Inc.1991-01-16
PATIENT EXAMINATION GLOVES-POWDER FREED (K910045)Pan-Century Rubber Products Sdn. Bhd.1991-01-15
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 (K905659)Em Diagnostic Systems, Inc.1991-01-15
DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS (K905312)Baxter Bentley Laboratories, Inc.1991-01-15
PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES (K910046)Pan-Century Rubber Products Sdn. Bhd.1991-01-15
THE O-RING SYSTEM - ORS (K900099)Attachments Intl., Inc.1991-01-15
AVI MODEL 600 SYRINGE PUMP, MODIFICATION (K904979)3M Avi, Inc.1991-01-15
TECHLYTE ELECTROLYTE ANALYZER (K905600)Technalysis, Inc.1991-01-15
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS (K904777)Baxter Healthcare Corp1991-01-15
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (K905730)Roche Diagnostic Systems, Inc.1991-01-15
GLYC-AFFIN(TM)-GA (K905513)Isolab, Inc.1991-01-15
CIBA CORNING ACS T4 IMMUNOASSAY (K905532)Ciba Corning Diagnostics Corp.1991-01-15
CLOSED SYSTEM FLUSH SET (K904994)Argon Medical Corp.1991-01-15
LAB-SITE (K905017)Telos Medical Corp.1991-01-15
PATIENT EXAMINATION GLOVES (K905665)Medical Products Search, Inc.1991-01-15
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST (K905100)Hewlett-Packard Co.1991-01-15
PATIENT EXAMINATION GLOVES-TEXTURED GLOVES (K910047)Pan-Century Rubber Products Sdn. Bhd.1991-01-15
EZ-SCREEN: AMPHETAMINES (K905700)Environmental Diagnostics, Inc.1991-01-15
PATIENT EXAMINATION GLOVES (K905551)Johnson & Johnson Medical, Inc.1991-01-15
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM (K903733)Institute For Clinical Applications1991-01-15
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (K903344)Kontron Instruments, Inc.1991-01-15
VARIOUS (K905319)Ivoclar North America, Inc.1991-01-15
HAWAIIAN SUPRACONDYLAR PLATE (K903697)Medpac1991-01-15
DEGUDENT GS (K905387)Degussa AG1991-01-15
DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. (K905311)Baxter Bentley Laboratories, Inc.1991-01-15
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER (K903448)Medical Engineering Corp.1991-01-14
THE THERATEST ACA TEST (K905301)Theratest Laboratories, Inc.1991-01-14
CHLAMYDIA SYSTEM SOFTWARE (CSS) (K904725)Kallestad Diag, A Div. of Erbamont, Inc.1991-01-14
DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL (K903439)Glovco Malaysia Sdn Bhd1991-01-14
RICH-MAR MODEL V ULTRASOUND (K904051)Rich-Mar Corp.1991-01-14
CLINI-CALC (K903135)Shasta Logic Corp.1991-01-14
ELIACHAR MODIFIED ESOPHAGEAL STENT (K904821)Hood Laboratories1991-01-14
AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (K904684)Amici, Inc.1991-01-14
ULTRA WAVE 101 (K905836)Ako USA, Inc.1991-01-14
THE BODY COOLER SYSTEM (K904998)Costa / French1991-01-14
AMICI XENON ADMINISTRATION SET (K903805)Amici, Inc.1991-01-14
DB 3000 A-SCAN SYSTEM (K904692)Ocuserv Instruments, Inc.1991-01-14
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (K901548)Shiley, Inc.1991-01-14
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM (K905162)Quidel Corp.1991-01-14
DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. (K905231)Dale Medical Products, Inc.1991-01-14
CT HILIGHT ADVANTAGE II (K904971)GE Medical Systems1991-01-14
DCW MODULAR PROXIMAL FEMORAL SYSTEM (K904028)Dow Corning Wright1991-01-14
BC 1220 ANALOG - IMPLANT BODY (K904711)Minimatic Implant Technology1991-01-14
ACME MODEL 8500 WHEELCHAIR SCALE (K910055)Acme Medical Scale Co.1991-01-14
PACSNET RESEARCH TOOLKIT (K905199)Siemens Gammasonics, Inc.1991-01-14
MODULAR UNIPOLAR SYSTEM (K902365)Howmedica Corp.1991-01-11
MODEL 3100-21: QUADRATURE SPINE COIL (K905095)Medical Advances, Inc.1991-01-11
PERRY XTENDA CUFF SURGICAL GLOVES (K905537)Smith & Nephew Perry1991-01-11
VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS (K904886)Florida Infusion Services, Inc.1991-01-11
MOOR LASER BLOOD FLOW MONITOR MBF3 (K905232)Moor Instruments, Ltd.1991-01-11
TRACH COLLAR (K904974)Rotek Corp.1991-01-11
MODEL 556 MONITOR (K905856)Ge Medical Systems Information Technologies1991-01-11
MODEL IW17.5A INTRA OPERATIVE TRANSDUCER (K904665)Kretztechnik AG1991-01-11
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (K905215)Cirrus Diagnostics, Inc.1991-01-11
MODIFIED WALKMED 400 (K905783)Medfusion, Inc.1991-01-11
MOOR LASER BLOOD FLOW MONITOR MBF3D (K905233)Moor Instruments, Ltd.1991-01-11
SRI JOHANI LATEX SURGEONS GLOVES (K904662)Transcorp1991-01-11
ABUSCREEN ONLINE TM FOR THC (K904996)Roche Diagnostic Systems, Inc.1991-01-11
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR (K904806)Fresenius USA, Inc.1991-01-11
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM (K903976)Kinamed, Inc.1991-01-09
ICON (K903315)Siemens Gammasonics, Inc.1991-01-09
ADJUSTABLE PEEP VALVE (K904874)Vital Signs, Inc.1991-01-08
KUDO (POWERED ROTATION BED) (K905390)Kinetic Concepts, Inc.1991-01-08
TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE (K905756)Titan Technology Intl., Inc.1991-01-08
ROBERTAZZI NASOPHARYNGEAL AIRWAY (K903618)Eastmed Enterprises, Inc.1991-01-08
IN-LINE ATS BLOOD RECOVERY BAG (K904794)Atrium Medical Corp.1991-01-08
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES (K904741)Telectronics Pacing Systems, Inc.1991-01-08
PARADERM(TM) SURGEON'S GLOVE ACCESSORY (K904903)Lovell-Schenck, Inc.1991-01-08
DYNAPULSE 200M (K904739)Pulse Metric, Inc.1991-01-08
MICRO-AIRE 4220-000 OSCILLATING SAW (K905277)Micro Surgical Instruments Corp.1991-01-08
LOBOW (K905250)Perinatal Systems1991-01-08
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD. (K902506)Puritan Bennett Corp.1991-01-08
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. (K903900)Ppg Hellige B.V.1991-01-08
OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C (K903134)Omron Marshall Products, Inc.1991-01-08
BIO-IMPEDANCE ANALYZER (K904109)Xitron Technologies, Inc.1991-01-08
DCL SYPHILIS-M CATALOG NO. 600-80 (K895964)Diagnostic Chemicals, Ltd. (Usa)1991-01-08
MODEL 3100-64: QUADRATURE SPINE COIL (K905104)Medical Advances, Inc.1991-01-08
CENTAURI YAG LASER SYST, EAR, NOSE , THROAT (K904627)Pfizer Laser Systems1991-01-07
REDI-RELEASE ABSORBENT DRESSING (K904604)Fountain Pharmaceuticals, Inc.1991-01-07
CENTAURI YAG LASER SYST, UROLOGY (K904629)Pfizer Laser Systems1991-01-07
CENTAURI YAG LASER SYST, GASTROENTEROLOGY (K904628)Pfizer Laser Systems1991-01-07
STARCAM 4000 (K904174)General Electric Co.1991-01-04
HAGIE PIN (K905347)O'Tec Corp.1991-01-04
U.S. TYPE CRUCIATE SLOT BONE SCREW (K905333)O'Tec Corp.1991-01-04
OSTEONICS HIP REVISION WEDGES (K905406)Osteonics Corp.1991-01-04
BIOPRO TRINITY ACETABULAR CUP (K904207)Biopro, Inc.1991-01-04
OSTEONICS(R) 6011 HIP STEM SERIES (K905158)Osteonics Corp.1991-01-04
A2J TELEMETER (K904127)A2j, Inc.1991-01-04
HA-TI (HAND-TITANIUM SCREW) IMPLANT (K901927)Mathys Corp. of North America1991-01-04
ECLIPSE ICA GLUCOSE (K905144)Biotope, Inc.1991-01-04
BROAD SELF-COMPRESSING PLATE (K905355)O'Tec Corp.1991-01-04
TRANSDUCER PROTECTOR (K904912)Filtertek, Inc.1991-01-04
SYSTEMATE GGT (EPOS APPLICATION) #65414 (K905662)Em Diagnostic Systems, Inc.1991-01-04
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Every clearance here is in the API, with alerts when new ones post.