Atlas FDA

1989

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

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RecordFirmDate
MODEL DT-BAL, BALANCE SAVER (K895323)Spectramed, Inc.1989-10-24
OS-1 OCCLUSION SYSTEM - 1 (K894839)Medical, Inc.1989-10-24
GLYCABEN (K893453)Exocell, Inc.1989-10-23
RS232 FLOW SENSOR AND SOFTWARE PACKAGE (K894680)Tamarac Systems Corp.1989-10-23
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. (K895108)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-23
URIC ACID PAP (K895665)Boehringer Mannheim Corp.1989-10-23
SYSTEMATE CREATININE TEST (CREA) #65413 (K895022)Em Diagnostic Systems, Inc.1989-10-23
FORTRESS 1000FS ADD-ON POWER UNIT (K895596)Fortress Scientific , Ltd.1989-10-23
GAUZE SPONGE (K895086)Keilei Intl., Inc.1989-10-23
MICRO-PLATE READER, MDX-1 (K894400)Medix Biotech, Inc.1989-10-23
MILENIA(TM) CORTISOL (MKCO1,5) (K895006)Diagnostic Products Corp.1989-10-23
BT-338N ELECTRONIC CLINICAL THERMOMETER (K894627)Integrated Display Technology, Ltd.1989-10-23
HI CHEM CALIBRATOR A+ (K895135)Hichem Diagnostics1989-10-23
CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST (K894644)Jeneric/Pentron, Inc.1989-10-20
PRIMIDONE (FPIA) KIT (K895567)Tudor Laboratories, Inc.1989-10-20
KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS (K894658)Howmedica Corp.1989-10-20
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR (K894630)Shiley, Inc.1989-10-20
REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER (K895409)Remington Products Company, LLC1989-10-20
TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE (K894721)The Traumafuse Co.1989-10-20
SKYROCK AND LIGHT SUPERBOND (K894639)Dent Zar, Inc.1989-10-20
MODIFIED ENDOGUIDE (K895559)Luxar Corp.1989-10-20
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (K894668)Shiley, Inc.1989-10-20
IMPLA-MED IMPLANT SYSTEM (K892124)Impla-Med1989-10-20
ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS (K895263)Heraeus Lasersonics, Inc.1989-10-20
SILICONE INSTRUMENT SHODS (K895591)Key Surgical, Inc.1989-10-20
PATIENT EXAMINATION GLOVES (LATEX) (K891301)Taiping Leasing Corp. Sdn. Bhd.1989-10-20
MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT (K895348)Lasag Medical Lasers1989-10-20
SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH (K891458)Back IN Action, Inc.1989-10-20
CYPRESS MEDICAL BONE SCREW & PLATES (K894719)Cypress Medical Mfg., Inc.1989-10-20
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES (K882270)KARL STORZ Endoscopy-America, Inc.1989-10-20
HEATED SERVO HUMIDIFIER, MODEL HDS 2 (K893122)Lifetronics, Inc.1989-10-20
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR (K895395)Baxter Healthcare Corp1989-10-19
DELTA-TECH(TM) CAST REMOVAL SYSTEM (K895861)Johnson & Johnson Professionals, Inc.1989-10-19
CLINISTAT LDH REAGENT TEST (K895138)Heraeus Kulzer, Inc.1989-10-19
ANETHESIA BREATHING CIRCUIT (K895357)F.L.W. Plastics, Inc.1989-10-19
SPINAL NEEDLE (K895453)Advance Medical Designs, Inc.1989-10-19
QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE (K894854)Image Enhancements1989-10-19
ELECTRO-TOUCH (ET) GLOVE (K890981)Psychoenergetic Systems, Inc.1989-10-19
BIOLOX CERAMIC BALL (K892644)Allo Pro Corp.1989-10-19
MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP (K894667)Pneumedics, Inc.1989-10-19
IRRI-EVACUATOR (K895757)Mikro-Tek Laboratories1989-10-19
SLEEPAP MASK (K894642)Medical Industries America, Inc.1989-10-19
LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER (K895718)Data Medical Associates, Inc.1989-10-19
ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR (K893394)Haemonetics Corp.1989-10-19
MIP/CT IMAGE PROCESSING WORKSTATION (K892712)Kontron Electronics1989-10-19
CORTISOL CLASP-BEAD EIA KIT (K895407)Biotecx Laboratories, Inc.1989-10-19
INTERTECH METERED DOSE ELBOW (K895144)Intertech/Ohio1989-10-19
EXUSORB(TM) GEL DRESSING (K895606)Controlled Therapeutics Corp.1989-10-19
MILENIA(TM) TOTAL T4 (MKT41,5) (K895840)Diagnostic Products Corp.1989-10-19
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM (K894632)Toshiba America Medical Systems, In.C1989-10-19
2.5 FRENCH LITHOTRIPTOR ELECTRODE (K894704)Northgate Research, Inc.1989-10-18
BIOSPOT HCG-RAPID PREGNANCY TEST (K894705)Princeton Biomedix1989-10-18
BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (K894750)Princeton Biomedix1989-10-18
GENERAL ASPERATOR (K895761)Kolster Methods1989-10-18
AGAR 3K NEUROMUSCULAR STIMULATOR (K882386)Solcoor, Inc.1989-10-18
MANAN PROSTATIC BIOPSY NEEDLE (K895897)Manan Medical Products, Inc.1989-10-18
CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC (K895762)Kolster Methods1989-10-18
PRECISION DENTAL ATTACHMENTS (K895986)Implant Support Systems, Inc.1989-10-18
EN-TRAP SYRINGE (K895203)The Medtech Group, Inc.1989-10-18
COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE (K894071)Sara Lee Corp.1989-10-18
COBE 2991 SUPPLEMENTARY DISPOSABLE SETS (K893962)Cobe Laboratories, Inc.1989-10-18
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS (K894934)Hycor Biomedical, Inc.1989-10-17
DIAMOND BLADE SURGICAL KNIVES (K895752)Magnum Diamond, Inc.1989-10-17
VINYL BAG W/GRAVITY ADMINISTRATION SET (K893541)Sandoz Nutrition1989-10-17
MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM (K895643)Orthoconcept, Inc.1989-10-17
ANTI-RNP AND ANTI-SM ANTIBODY TEST (K895338)Immco Diagnostics, Inc.1989-10-17
LAN.0800Q/2800Q (K895872)Amersham Corp.1989-10-17
EMS 300 MUSCLE STIMULATORS (K890434)Paranamics, Inc.1989-10-17
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY (K895380)Serono-Baker Diagnostics, Inc.1989-10-17
MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT (K894511)Intl. Ophthalmic Industries Corp.1989-10-17
DISPOSABLE CATHETER PRESSURE TRANSDUCER (K894033)Deseret Medical, Inc.1989-10-17
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA (K895496)Incstar Corp.1989-10-17
CORDIS STEERABLE COATED GUIDEWIRE (K894633)Cordis Corp.1989-10-17
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN (K895808)Technicon Instruments Corp.1989-10-17
IQ LDH (K894578)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-17
PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT (K894684)Pioneering Technologies, Inc.1989-10-17
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (K895313)Dynatech Laboratories, Inc.1989-10-17
RELIANCE LIGHT CURE RETAINER ACRYLIC (K894564)Reliance Orthodontic Products, Inc.1989-10-17
PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS (K894512)Intl. Ophthalmic Industries Corp.1989-10-17
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD (K894494)Biotronik, GmbH & Co.1989-10-17
HOLLISTER FEEDING TUBE ATTACHMENT DEVICE (K893888)Hollister, Inc.1989-10-17
CLINISTAT POTASSIUM REAGENT TEST (K895047)Heraeus Kulzer, Inc.1989-10-17
VINYL BAG W/PUMP ADMINISTRATION SET (K893540)Sandoz Nutrition1989-10-17
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645)Dynatech Laboratories, Inc.1989-10-17
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 (K890875)Ppg Industries, Inc.1989-10-17
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 (K895119)Em Diagnostic Systems, Inc.1989-10-17
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 (K895118)Em Diagnostic Systems, Inc.1989-10-17
SOURCERER (K894902)Oakfield Instruments, Ltd.1989-10-17
MENTOR DUCTAL CATHETERS (K895285)Mentor Corp.1989-10-17
WHITESIDE ORTHOLOC M.A. TIBIAL BASE (K894504)Dow Corning Wright1989-10-17
EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (K894626)Bion Ent., Ltd.1989-10-16
RESPIRATORY SYNCYTIAL VIRUS (K894623)Bion Ent., Ltd.1989-10-16
TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (K894261)Microbix Biosystems, Inc.1989-10-16
RUBELLA ANTIGEN AND CONTROL ANTIGEN (K894262)Microbix Biosystems, Inc.1989-10-16
IMMUNODOT RUBELLA TEST (K894546)General Biometrics, Inc.1989-10-16
CLP CK/LD ISOENZYME CONTROL (K894554)Creative Laboratory Products, Inc.1989-10-16
SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION (K895029)Surgical Laser Technologies, Inc.1989-10-16
UNI-STICK PLASTIC LIGATURES (K891331)American Orthodontics1989-10-16
LIKON (K881777)Northwood Intl., Corp.1989-10-16
IMMUNO/ASO (K894780)Immunostics Co., Inc.1989-10-16
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Every clearance here is in the API, with alerts when new ones post.