Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COOL CAST(R) (K903946)Hawthorne Products, Inc.1990-12-31
VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES (K904560)Valleylab, Inc.1990-12-31
NONABSORBABLE POLYPROPYLENE SURGICAL MESH (K905655)United States Surgical, A Division of Tyco Healthc1990-12-31
BRODA WHEELCHAIR (K905671)Broda Ent., Inc.1990-12-31
ROMFLEX REHABILITATION EQUIPMENT (K905299)Dyna Flex, Intl.1990-12-31
LINGRAPHICA VISUAL LANGUAGE PROSTHESIS (K905576)Tolfa Corp.1990-12-31
ORION STERILE OR TOWELS (K903117)Orion Life Systems, Inc.1990-12-31
PRIDE SPIRIT (K905271)Pride Health Care, Inc.1990-12-31
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (K904795)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-31
ALKALINE PHOSPHATASE (K905684)Amresco, Inc.1990-12-28
BIO-GUARD SHAVE PREP TRAY (K905003)Network Medical Systems, Inc.1990-12-28
EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 (K904644)Eurosun, Inc.1990-12-28
COAGULATION REFERENCE PLASMA, NORMAL (K905203)Medical Diagnostic Technologies, Inc.1990-12-28
FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET (K904545)Valleylab, Inc.1990-12-28
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE (K905015)Surgitek1990-12-28
GLASSMAN STONE EXTRACTION SET (K904472)Wilson-Cook Medical, Inc.1990-12-28
MEMORYMATE MODEL 8270 ITE HEARING AID (K905483)3M Company1990-12-28
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING (K903844)Cordis Corp.1990-12-28
MEASLES IGG MICROASSAY (K903961)Diamedix Corp.1990-12-28
MICROFLO (K904557)Life-Tech Intl., Inc.1990-12-28
RESP-EZ(TM) RESPIRATORY MONITORING BELT (K903300)Epm Information Systems, Inc.1990-12-28
PALEX IRRIGATION SET (K904586)Palex Intl. SA1990-12-28
HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM (K904927)Hennson Intl., Inc.1990-12-28
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM (K904403)C.R. Bard, Inc.1990-12-28
ABUSCREEN ONLINE TM FOR OPIATES (K904997)Roche Diagnostic Systems, Inc.1990-12-27
THERATEK GROUP EXCHANGE CATHETER (K904680)Dow Corning Wright1990-12-27
NEW COBE SATURATION/HEMATOCRIT MONITOR (K904336)Cobe Laboratories, Inc.1990-12-27
ACROMED SACRAL SCREW (K903376)Acromed Corp.1990-12-27
CGA-112 COPING GOLD ALLOY (K903113)Minimatic Implant Technology1990-12-27
MAGNESIUM REAGENT (K905544)Amresco, Inc.1990-12-27
NEONATAL VENTILATOR CIRCUIT (K903083)Hudson Respiratory Care, Inc.1990-12-27
TEMPORARY DENTAL CEMENT (K904034)Medical Device Inspection Co., Inc.1990-12-27
THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM (K905197)Ormco Corp.1990-12-27
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE (K905697)Impact Instrumentation, Inc.1990-12-27
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS (K905147)Hewlett-Packard Co.1990-12-27
AFFINITY FSH TEST SYSTEM (K905592)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-27
REFLECTANCE SENSOR (RS-10) (K904039)Nellcor, Inc.1990-12-27
CENTRAL VENOUS PRESSURE MANOMETER (K904674)Medex, Inc.1990-12-27
MICRO-MISTER (K903580)Bp , Ltd.1990-12-27
FIRST MEDIC MODEL 510 (K896903)Spacelabs, Inc.1990-12-27
CAPTIA(R) SYPHILIS M, MODIFICATION (K904524)Mercia Diagnostics , Ltd.1990-12-26
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS (K904569)Syva Co.1990-12-26
STATPAL BLOOD GAS MONITORING SYSTEM (K903965)Ppg Industries, Inc.1990-12-26
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION (K905521)Microgenics Corp.1990-12-26
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST (K904082)Cholestech Corp.1990-12-26
CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0 (K905222)Nuccardiac Software, Inc.1990-12-26
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) (K904612)Medical Technical Products1990-12-26
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM (K904081)Heraeus Kulzer, Inc.1990-12-26
EMIT(R) II CANNABINOID 20 NG ASSAY (K904570)Syva Co.1990-12-26
COULTER DIRECT BILLRUBIN REAGENT (K905622)Coulter Electronics, Inc.1990-12-26
EMIT(R) II CANNABINOID 50 NG ASSAY (K904571)Syva Co.1990-12-26
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (K895965)Diagnostic Chemicals, Ltd. (Usa)1990-12-26
EMIT(R) II CANNABINOID 100 NG ASSAY (K904568)Syva Co.1990-12-26
CHEM-CHEX LIPID (K905389)Streck Laboratories, Inc.1990-12-26
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR (K904767)Analytical Control Systems, Inc.1990-12-26
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST (K903126)Crystal Diagnostics, Inc.1990-12-26
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL (K905296)Cholestech Corp.1990-12-26
GLYC-AFFIN GP (K904814)Isolab, Inc.1990-12-26
G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS (K902987)Electromek Diagnostic Systems, Inc.1990-12-26
A-1101 CAST ABUTMENT (K903039)Minimatic Implant Technology1990-12-26
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE (K903643)Deknatel, Inc.1990-12-24
PANOSOL II UVA-218 (K904426)National Biological Corp.1990-12-24
SYSTEMS FLOW 2000 (K902993)Universal Hydrotech, Inc.1990-12-24
MODEL 2001, MODIFICATION (K905029)Medfusion, Inc.1990-12-24
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP (K904588)United States Surgical, A Division of Tyco Healthc1990-12-24
PANOSOL II UVB-206 (K904427)National Biological Corp.1990-12-24
WILL-CERAM W-1 (K905324)Ivoclar North America, Inc.1990-12-24
EPISENSOR (K903224)Palex Intl. SA1990-12-24
SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE (K904470)Summit Technology, Inc.1990-12-24
SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP (K904906)Chathamborough Research Group, Inc.1990-12-24
PANOSOL II UAB-228 (K904428)National Biological Corp.1990-12-24
HARMONY LINE ALLOYS (K905330)Ivoclar North America, Inc.1990-12-24
MINIGOLD (K905326)Ivoclar North America, Inc.1990-12-24
WILL-CERAM Y AND WILL -CERAM Y-1 (K905323)Ivoclar North America, Inc.1990-12-24
INDX DIP S TICKS (K901597)Intercare Diagnostics, Inc.1990-12-21
ENEMA BULB (K904534)R.A.C., Inc.1990-12-21
HEARSET TELEPHONE HEARING SYSTEM (K903145)Starkey Laboratories, Inc.1990-12-21
WILSON-COOK BALLOON DILATION CATHETERS (K900924)Wilson-Cook Medical, Inc.1990-12-21
MICRO-AIRE MODEL NUMBER: MK-426 (K905097)Micro Surgical Instruments Corp.1990-12-21
HIGH RISK (K903559)Medical Resources, Ltd.1990-12-21
SEROFAST (K903958)Intl. Mycoplasma/Mdc Assoc.1990-12-21
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED (K904523)Alamar Biosciences Laboratory, Inc.1990-12-21
FEEDING TUBE (K896734)Unoplast A/S1990-12-21
QAR HANDPIECE (K904671)Collagen Corp.1990-12-21
KAPPER (K904527)Senair-Mot1990-12-21
ELLIPSE 2.3 (K905621)Everest & Jennings, Inc.1990-12-21
THE VISONIC DOME(TM) (K902306)Vista Vision1990-12-21
PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY) (K905585)Pioneer Trading Co.1990-12-21
STERILE SURGICAL GLOVES/DOUBLE GLOVER (K905012)American Advisors, Inc.1990-12-21
X-L AND X-LX (K905325)Ivoclar North America, Inc.1990-12-21
CHIROFLEX FORCEPS (K903575)Chiron Ophthalmics1990-12-21
YUEFA DISPOSABLE SYRINGE (K902178)Blue & Red Corp.1990-12-21
MAMBA CONDOM (RUBBER LATEX) (K902907)Rfsu1990-12-21
ARIES MELDICAL MODEL 2100HC HANK CRANK (K903925)Aries Medical, Inc.1990-12-21
BONE STAPLE(S) (K904553)Synthes (Usa)1990-12-21
MICRO-MIST NEBULIZER (K904196)Bp , Ltd.1990-12-21
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF (K903132)Ortho Diagnostic Systems, Inc.1990-12-21
MRT35-SP (K905442)Toshiba America Mri, Inc.1990-12-21
MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (K903209)Adler Instrument Co.1990-12-21
SURGICAL TROCAR AND CANNULA (K904379)Applied Vascular Devices, Inc.1990-12-21
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Track 1990 automatically

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