Atlas FDA

1989

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

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RecordFirmDate
RIA-GNOST FERRITIN (K890697)Cambridge Medical Technology1989-03-16
EIA READER MODEL EL301 (K890854)Bio-Tek Instruments, Inc.1989-03-16
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) (K890609)Intl. Immunoassay Laboratories, Inc.1989-03-16
RIA-GNOST PROGESTERONE (K890836)Cambridge Medical Technology1989-03-16
GRAM STAIN CONTROL SLIDE (K890718)Scientific Device Laboratory, Inc.1989-03-16
NICOLET VIKING II SYSTEM (K890495)Nicolet Instrument Corp.1989-03-16
ABUSCREEN FP FOR CANNABINOIDS (K890887)Roche Diagnostic Systems, Inc.1989-03-16
CYTEX ONE AND CYTEX TWO (K890283)Anderson Winn Paper Co.1989-03-16
EPIDURAL ANESTHESIA TRAY (K885278)Preferred Medical Products1989-03-16
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B (K891154)Atlantic Antibodies1989-03-16
EMPI MULTIDAY TENS DISPOSABLE ELECTRODE (K890614)Empi1989-03-16
DEFEND LATEX EXAMINATION GLOVES (K891157)Carl Parker Associates, Inc.1989-03-16
LATEX EXAMINATION GLOVES (K891065)Modern Rubber Industrial Co., Ltd.1989-03-16
STARTRAC (K890793)Unisen, Inc.1989-03-16
FEMORAL ANGIOGRAPHY DRAPE (K890101)Medical Plastics, Inc.1989-03-16
CRYPTOSPORIDIUM CONTROL SLIDE (K890670)Scientific Device Laboratory, Inc.1989-03-16
ELECTRONIC DIGITAL THERMOMETER (K885308)Ewig Industries Co. , Ltd.1989-03-16
EMPI REUSEABLE PIN-STYLE TENS ELECTRODE (K890747)Empi1989-03-16
RESUBMITTED SCANORA (K884650)Orion Corp.1989-03-16
BETA-2 MICROGLOBULIN EIA (K890694)Serex, Inc.1989-03-16
STUART TITANIUM SURGICAL MESH (K890601)Stuart1989-03-16
MONO-CUBE(TM) (K890991)Difco Laboratories, Inc.1989-03-16
TSH MICROASSAY (K890579)Diamedix Corp.1989-03-16
EMPI ISLAND TENS ELECTRODE (K890605)Empi1989-03-16
RECONDITIONED ASTRA (TM) 8 (K883298)Associated Electro-Medical Services, Inc.1989-03-16
RECONDITIONED ASTRA(TM) 4 (K883350)Associated Electro-Medical Services, Inc.1989-03-16
ABUSCREEN FP FOR MORPHINE (K890888)Roche Diagnostic Systems, Inc.1989-03-15
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) (K890414)Amersham Corp.1989-03-15
MICROLASE 8 0 0 (OPHTHALMIC LASER) (K890086)Keeler Instruments, Inc.1989-03-15
APEC GLUCOSE ANALYZER (K890524)Amdev, Inc.1989-03-15
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (K890619)Elite Diagnostic , Ltd.1989-03-15
MULTI CAMERA CONTROL UNIT (MCCU) (K884028)Leybold-Inficon, Inc.1989-03-15
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B (K884477)Shimadzu Precision Instruments, Inc.1989-03-15
B.A.C. 1000 MOBILE STANDING DEVICE (K884840)Luconex, Inc.1989-03-15
ASTRO TRACE (MODEL AT-02) (K885137)The LE Blanc Corp.1989-03-15
AML BOWED FEMORAL HIP (K885338)Depuy, Inc.1989-03-15
PG-NUMERIC(TM) (K883411)Isolab, Inc.1989-03-15
ABUSCREEN FP BUFFER REAGENT (K890883)Roche Diagnostic Systems, Inc.1989-03-15
TOTAL KNEE CPM (K885182)Invacare Corp.1989-03-15
HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES (K890281)Cambridge Bioscience Corp.1989-03-15
SYSTEM 3000 FLUIDIZED AIR BED (K890935)Dermanetics Corp.1989-03-15
RIATRAC PLUS (K890470)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-15
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680 (K890201)Medtronic Vascular1989-03-15
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER (K890060)Depuy, Inc.1989-03-15
LYME DISEASE IFA (IGM) (K883767)Hillcrest Biologicals1989-03-15
VAPAMASTA 5 (K884686)Dentsply Intl.1989-03-15
ARROW MICRO COMPUTER CONTROL (K885212)Invacare Corp.1989-03-15
MEDILOG 9000-II AMBULATORY RECORDER (K890647)Oxford Medilog, Inc.1989-03-15
VISUWELL REAGIN TEST 960 TEST KIT (K885298)Allelix Diagnostics, Inc.1989-03-15
ABUSCREEN FP FOR PHENCYCLIDINE (K890882)Roche Diagnostic Systems, Inc.1989-03-15
ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS (K885261)Invacare Corp.1989-03-15
BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES (K890566)Medi-Source, Inc.1989-03-15
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP (K890325)C.R. Bard, Inc.1989-03-15
ENGSTROM ELIZA + CO2 ANALYZER (K890112)Gambro, Inc.1989-03-15
VISTA MR 2055 HP SYSTEM (K885047)Philips Medical Systems (Cleveland), Inc.1989-03-14
THERMO-PACK (K890924)Medical Manufacturers, Inc.1989-03-14
STERILE LAPAROTOMY SPONGES (K890770)Cypress Medical Products, Ltd.1989-03-14
NEEDLE STICK (K885122)Poncy, Inc.1989-03-14
MEDSURG GREENE NEEDLE (K885145)Medsurg Industries, Inc.1989-03-14
SC-1000 WITH SUFFIXES (SCAN CONVERTER) (K890745)Eigen1989-03-14
SONY VIDEO GRAPHIC PRINTER UP-850 (K890826)Sony Corp. of America1989-03-14
SURGICAL GLOVES (K884622)Globe Ent., Inc.1989-03-14
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER (K884552)Arrow Intl., Inc.1989-03-14
VITALON MATRESS MASSAGE MODEL M-MX (K890923)Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.1989-03-14
KODAK MULTILOADER 700 (K885207)Eastman Kodak Company1989-03-14
OMNIFILTER MAIN FLOW BACTERIA FILTER (K890362)Puritan Bennett Corp.1989-03-14
GIARDIA STOOL ANTIGEN TEST KIT (K890003)Lmd Laboratories1989-03-14
PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD (K890878)U.S. Imaging, Inc.1989-03-14
MICK 200-TP AND MICK TP NEEDLE (K890341)Mick Radio-Nuclear Instruments, Inc.1989-03-14
RT6800 ECHOCARDIOGRAPHY SYSTEM (K885228)General Electric Co.1989-03-14
TC SYSTEM-HANDLE (K890866)Transmedical Corp.1989-03-14
ATTACHABLE LANZ (TENTATIVE) (K885216)Mallinckroot, Inc.1989-03-14
NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER (K881865)Norland Corp.1989-03-14
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT (K890193)Puritan Bennett Corp.1989-03-14
STERILE PATIENT EXAMINATION GLOVE (K891103)Boston Medical Corp.1989-03-14
DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS (K890710)Somatics, Inc.1989-03-14
O.R. TOWELS (STERILE) (K890709)Cypress Medical Products, Ltd.1989-03-14
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY (K884047)Disease Detection International, Inc.1989-03-14
TC SYSTEM-COVER (K890867)Transmedical Corp.1989-03-14
BRYMASCAN-A (K881336)Brymill Corp.1989-03-14
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK (K890771)3M Company1989-03-14
BAG DECANTER (K890272)Superior Medical Products1989-03-14
MENTOR MDS (K885155)Imex1989-03-14
THE PATHFINDER SYSTEM (K890483)Denmark Assoc.1989-03-14
MED-A-CALL ASSIST DEVICE (K890596)Silent Call Corp.1989-03-14
MEDRAD SCPD 1000 (K890394)Medrad, Inc.1989-03-14
PERSONAL TRANSFER SYSTEM (K885270)Columbus Mckinnon Corp.1989-03-14
FLORIDA PROBE PERIODONTAL PROBE (K890493)Florida Probe Corp.1989-03-13
ABUSCREEN FP FOR COCAINE METABOLITE (K890885)Roche Diagnostic Systems, Inc.1989-03-13
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (K890089)Gen-Probe, Inc.1989-03-13
EDWARDS DISPOSABLE ARTHROSCOPY CANNULA (K884301)Baxter Healthcare Corp1989-03-13
IMPRES-MB REAGENT A AND REAGENT B (K890543)Intl. Immunoassay Laboratories, Inc.1989-03-13
SHARPLAN MODEL 2106 (K891016)Sharplan Lasers, Inc.1989-03-13
PROGENE MICROALBUMINURIA SCREEN (K882538)Progene Corp.1989-03-13
LEONARD MEDICAL 1.7MM ARTHROSCOPE (K884314)Leonard Medical, Inc.1989-03-13
AEGIS(TM) CONDOMS (K883409)Green Cross Medical Supplies Corp.1989-03-13
ACTICLOT C KIT (K884941)American Diagnostic Corp.1989-03-13
LIPASE SR LIQUID STABLE REAGENT SET (K885078)Medical Analysis Systems, Inc.1989-03-13
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST. (K890649)Osteonics Corp.1989-03-13
20/20 ORTHODONTIC CERAMIC BRACKET (K890145)American Orthodontics1989-03-13
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Track 1989 automatically

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