Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT (K870518)Surgitek1987-04-29
NEW FUCHSIN SOLUTION (K871545)Sigma Diagnostics, Inc.1987-04-29
CALCIUM TEST (K870629)Sclavo, Inc.1987-04-29
DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG (K870201)Difco Laboratories, Inc.1987-04-29
CONTROLCHEK(TM) (K871445)Petra Biomedical Products, Inc.1987-04-29
TOMTEC GRAM STAINER CRYSTAL VIOLET (K871532)Remel Co.1987-04-29
BROTH ELUTION DISKS CLINDAMYCIN 10MCG (K870175)Difco Laboratories, Inc.1987-04-29
TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES (K871483)Isratech Marketing Corp.1987-04-29
TOXOPLASMA IGM MICROASSAY (K870753)Diamedix Corp.1987-04-28
CB-7 ELECTRONIC EPILATOR (K871372)R. A. Fischer Co. Corp.1987-04-28
BACTO(R) STREP GROUP KIT (K870854)Difco Laboratories, Inc.1987-04-28
CRYOSURGICAL PROBE (K871314)Western Medical Research1987-04-28
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT (K864643)Pacific Hemostasis1987-04-28
MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20 (K870067)Vygon Corp.1987-04-28
THORASTAT ATR-XXXX (K870792)Gish Biomedical, Inc.1987-04-28
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU. (K871331)Ventrex Laboratories, Inc.1987-04-28
CLEARVIEW CW-10 (K870210)Clearview Instruments, Inc.1987-04-28
BPA CARDIOVASCULAR PRESSURE AMPLIFIER (K870783)Fisher Imaging Corp.1987-04-27
'EXMOOR' DAS GUPTA LARYNGEAL KEEL (K864936)Exmoor Plastics , Ltd.1987-04-27
#014160-TAB TUBING ROTATOR ADAPTOR (K870325)Clinical Connections, Inc.1987-04-27
SCHIRMER NYLON SUTURE LASER LENS (K871099)Ocular Instruments, Inc.1987-04-27
PACEMAKER FUNCTION ANALYZER (K870909)Paceart, Inc.1987-04-27
BLOOD VESSEL CONNECTOR (K871408)Quali-Med, Inc.1987-04-27
DROP MATE (K871326)Mtr Enterprises, Ltd.1987-04-27
KNIFE, OPHTHALMIC (K871285)Trueline Instruments, Inc.1987-04-27
INTRA-ARTICULATED ARTHRO POWER SYSTEM (K871250)Richard Wolf Medical Instruments Corp.1987-04-27
SDI TOTAL HIP SYSTEM (K871299)Orthomet, Inc.1987-04-27
CENTRAL VENOUS CATHETER (K870075)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-04-27
VASCATH VASCULAR CATHETER PLACEMENT KIT (K870542)Titan Medical, Inc.1987-04-27
SURE DROP (K870905)Sheldon Eyedrop Support, Inc.1987-04-24
BIOJECTOR SYRINGE SYSTEM (K861687)Bioject, Inc.1987-04-23
CARERITE & COST RITE NYLON STERILIZATION FILM (K870147)Cost Rite Health Products, Inc.1987-04-23
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE (K870582)Strato Medical Corp.1987-04-23
TIMLEINE(TM) VENIPUNCTURE SYSTEM (K870770)Ipax, Inc.1987-04-23
(I) LV AND (II) HV SERIES CANNULA (K871043)Celebration Medical Products, Inc.1987-04-23
MODEL MICRO ST AMBULATORY ECG MONITOR (K870537)Advanced Medical Products, Inc.1987-04-23
FOUNDATIONS PLUS ABDOMINAL BAND 1100 (K871138)Foundations Plus, Inc.1987-04-23
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 (K871414)Em Diagnostic Systems, Inc.1987-04-23
PT HEPARIN ADSORBENT (K870771)Probe-Tek, Inc.1987-04-23
PACE 10 NON-INVASIVE EXTERNAL PACEMAKER (K871176)Medac, Inc.1987-04-23
MODEL 192 PRINTER (K870538)Advanced Medical Products, Inc.1987-04-23
SUN CAPSULE I & II SUNTANNING BOOTH (K871237)Sun Capsule, Inc.1987-04-23
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET (K870581)Strato Medical Corp.1987-04-23
PROTEIN S CONTROL PLASMA (K870917)American Bioproducts Co.1987-04-23
T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT (K870573)Cambridge Medical Technology1987-04-22
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION (K870544)Beckman Instruments, Inc.1987-04-22
FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 (K871320)American Research Products Co.1987-04-22
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) (K871415)Dynatech Laboratories, Inc.1987-04-22
THE FM-212A BIOFEEDBACK UNIT (K861950)Hosa Technology, Inc.1987-04-22
EMT-102 CARDIAC MONITOR (K870049)Evergreen Medical Technologies, Inc.1987-04-22
MATRIX LD & LD/LASER DIGITIZER (K860777)Matrix Instruments1987-04-22
OMEGA T100 (K870666)Henley Intl.1987-04-22
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD (K871301)American Monitor Corp.1987-04-22
QM300 IGG ANTIBODY PACK (K871340)Kallestad Diag, A Div. of Erbamont, Inc.1987-04-22
OMEGA T200 (K870667)Henley Intl.1987-04-22
ENZYGNOST ANTI-VZV IGG TEST (K863317)Behring Diagnostics, Inc.1987-04-22
COLORIMETRIC URIC ACID REAGENT SET (K871417)Biochemical Trade, Inc.1987-04-22
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS (K870928)Electro-Nucleonics Laboratories, Inc.1987-04-22
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS (K871321)American Research Products Co.1987-04-22
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (K870949)Millipore Corp.1987-04-22
SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS (K870179)Polinelli1987-04-22
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM (K871319)Helena Laboratories1987-04-22
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR (K870142)Cardio-Pace Medical, Inc.1987-04-22
BACTIGEN SALMONELLA-SHIGELLA TEST (K870813)Armkel, LLC1987-04-22
CHLORIDE TEST (K870630)Sclavo, Inc.1987-04-22
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER (K871140)Aries Medical, Inc.1987-04-22
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS (K871352)Helena Laboratories1987-04-22
DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS (K871026)Labeltape Meditect, Inc.1987-04-22
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 (K871330)Em Diagnostic Systems, Inc.1987-04-22
URESIL CAROTID ARTERY SIZERS (K871148)Uresil Corp.1987-04-22
GEN-PROBE BETA-LACTAMASE TEST KIT (K870422)Gen-Probe, Inc.1987-04-21
BIOCHEM 8090 CAPNOGRAPH (K871133)Biochem International, Inc.1987-04-21
CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION (K870561)Diversified Diagnostic Industries1987-04-21
C.P.A.P. NASAL CANNULA (K871157)Hudson Oxygen Therapy Sales Co.1987-04-21
O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP (K871100)Matheson Gas Products, Inc.1987-04-21
KULTSURE (K871404)Ncs Diagnostics, Inc.1987-04-21
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY (K871346)Dako Corp.1987-04-21
RAPID AS LATEX (K862530)Dilab, Inc.1987-04-21
CUFFED TRACHEAL TUBE (MULTIPLE) (K871204)Mallinckrodt Critical Care1987-04-21
CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS (K870410)Diversified Diagnostic Industries1987-04-21
M-10 VENTILATION MONITOR (K871139)Bio-Med Devices, Inc.1987-04-21
PROTHROMBIN TIME TEST (K870596)U. S. Diagnostics, Inc.1987-04-20
O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF (K871102)Matheson Gas Products, Inc.1987-04-20
I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT (K871194)Cronus1987-04-20
COAGULATION CONTROL, LEVEL III (K870687)U. S. Diagnostics, Inc.1987-04-20
0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F. (K871101)Matheson Gas Products, Inc.1987-04-20
MODIFIED CPREVIVER (K871147)Augerscope, Inc.1987-04-20
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (K864998)Boots-Celltech Diagnostics, Inc.1987-04-20
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM (K865101)Spectramed, Inc.1987-04-20
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA (K864597)Gen-Probe, Inc.1987-04-20
CARDIOTEAM (K870527)Cardiac Network, Inc.1987-04-20
MODEL 2000W OPTION H CONFIGURATION (K871302)Edentec Corp.1987-04-20
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST (K864006)Medical Diagnostic Technologies, Inc.1987-04-20
COAGULATION CONTROL, LEVEL I (K870685)U. S. Diagnostics, Inc.1987-04-20
COAGULATION CONTROL, LEVEL II (K870686)U. S. Diagnostics, Inc.1987-04-20
O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P (K871103)Matheson Gas Products, Inc.1987-04-20
ARTHROFLATOR (K865066)F.M. Wiest USA, Inc.1987-04-20
DUAL SUBSTRATE ANA (K871395)Val Tech Diagnostics, Inc.1987-04-20
S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP (K870271)Joint Medical Products Corp.1987-04-20
PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS (K871132)Deltec Systems, Inc.1987-04-20
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Track 1987 automatically

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