Atlas FDA

1989

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

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RecordFirmDate
SMDS460 SURGICAL MONITOR DISPLAY SYSTEM (K890353)Vidco, Inc.1989-03-02
SENSATIONS BRAND CONDOMS (K871358)Apex Medical Technologies, Inc.1989-03-01
FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT (K885339)Superior Healthcare Group, Inc.1989-03-01
KODAK X-OMATIC RA CASSETTE (K890750)Eastman Kodak Company1989-03-01
STANDARD LATEX CONDOM (K884399)Schmid Laboratories, Inc.1989-03-01
KOTEX SECURITY TUBE TAMPONS (K885194)Kimberly-Clark Corp.1989-03-01
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. (K882080)Aequitron Medical, Inc.1989-03-01
MIDWIFERY/OBSTETRICAL FORCEPS (K890385)Kinetic Medical Products1989-03-01
CIMPAT S TEMPORARY DENTAL CEMENT (K885007)Specialites Septodont1989-03-01
INTERTECH UNIVERSAL HYDROPHOBIC FILTER (K890346)Intertech/Ohio1989-03-01
OBSTETRICAL SAFETY SYSTEM (K884868)Buckman Co., Inc.1989-03-01
WIDEX BTE HEARING AID MODEL Q8 (K885128)Widex Hearing Aid Co., Inc.1989-03-01
ZINETICS(R) EMC (K884527)Zinetics Medical, Inc.1989-02-28
MONOPLACE HYPERBARIC EXTENSION SET (L 11055) (K884141)Abbott Laboratories1989-02-28
MAGLINTE ENTEROCLYSIS CATHETER (K884379)Lafayette Pharmacal, Inc.1989-02-28
DREYER CURVED ENDOILLUMINATOR (K884556)Advanced Surgical Products, Inc.1989-02-28
STICK-GARD SAFETY NEEDLE (K890620)Ziehm International, Inc.1989-02-28
EP-100 (SERIES) (K884415)Stereotactic Medical Systems, Inc.1989-02-28
BT-1 INFUSION PUMP (K881759)Ferring Laboratories, Inc.1989-02-28
SHAPIRO CUTTER (K890544)H.S. Intl. Co., Inc.1989-02-28
NEVISCAN MODEL N - 100 (K884989)Special Products, Inc.1989-02-28
INFUSION FLUID WARMER (K883873)Pmt Corp.1989-02-28
URINARY DRAINAGE UNIT (K890551)Consolidated Products & Services, Inc.1989-02-28
CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) (K890550)Consolidated Products & Services, Inc.1989-02-28
SIEMENS PACS/1-B (OPTICAL DISK OPTION) (K884995)Siemens Gammasonics, Inc.1989-02-28
LIFECARE MICRO PUMP (K883796)Abbott Laboratories1989-02-28
N.M.D.C. USER PROTECTIVE HYPODERMIC SYRINGE SYSTEM (K883073)National Medical Device Corp.1989-02-28
ULTIMA WHEELCHAIR CUSHION (K890653)Clark Pillow Co., Inc.1989-02-28
BARD UMBILICAL VESSEL CATHETER (K890685)C.R. Bard, Inc.1989-02-28
M.I.P. - PUMP (K882249)Intro-Med, Inc.1989-02-28
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE (K885129)Bivona Medical Technologies1989-02-27
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE (K885169)Boston Scientific Corp1989-02-27
ADVANTAGE (K885246)Clark Davis Medical Systems, Inc.1989-02-27
MICROLITE TUBE LUMINOMETER #011-902-0000 (K890502)Dynatech Laboratories, Inc.1989-02-27
INFUSA-PLATE(TM) EX (K885083)Kalayjian Ent.1989-02-27
GLUCOSE (GOD) REAGENT (K890336)Alpkem Corp.1989-02-27
NIDEK AR-1200 (K890559)Nidek, Inc.1989-02-27
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY (K890409)Baxter Healthcare Corp1989-02-27
TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM (K884788)Toshiba Medical Systems1989-02-27
TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM (K884555)Toshiba Medical Systems1989-02-27
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT (K884753)Advanced Magnetics, Inc.1989-02-27
DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) (K883324)Siemens Gammasonics, Inc.1989-02-27
COMPRESSION FORCEPS (K890382)Kinetic Medical Products1989-02-27
LC, CARDIAC POSITIONER #B5078A (K890348)General Electric Co.1989-02-27
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC (K890540)Abbott Laboratories1989-02-27
ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES (K890641)Acufex Microsurgical, Inc.1989-02-27
VAGINAL SPECULUM (K890376)Kinetic Medical Products1989-02-27
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE (K885130)Bivona Medical Technologies1989-02-27
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. (K884889)Protek, Inc.1989-02-27
MALLEABLE PLACENTA CURETTE (K890387)Kinetic Medical Products1989-02-27
TORAY FILTRYZER BK SERIES (K883407)Toray Industries (America), Inc.1989-02-27
BIOTENS (K884814)Trekk Intl.1989-02-27
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER (K884378)Coulter Corp.1989-02-27
RUG BUG WHEEL CHAIR (K890490)Sinties Scientific, Inc.1989-02-27
BALANCE SYSTEM (K884926)Chattanooga Group, Inc.1989-02-27
CALCIUM PLUS PROCEDURE (K890302)Data Medical Associates, Inc.1989-02-27
SURE COUNT LIGHT HANDLE COVER (K890539)Kleen Test Products1989-02-27
MOLTENO IMPLANT (K890598)Iop, Inc.1989-02-27
PROTECTOR (SURGICAL INSTRUMENT) (K890314)Richard-Allan Medical Ind., Inc.1989-02-27
AMPLAID EMG15 (K884071)Amplus Corp.1989-02-27
PMS ANGIO DRAPE (K890471)Professional Medical Services1989-02-27
SUTTER HOSPITAL CPM (K890607)Sutter Corp.1989-02-27
CERVICAL BIOPSY FORCEPS (K890380)Kinetic Medical Products1989-02-27
LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT (K884018)Lamelli Pulmonary Research Center1989-02-27
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE (K890749)R&D Systems, Inc.1989-02-27
ACUFEX FIXATION BUTTON (K884565)Acufex Microsurgical, Inc.1989-02-27
CLINISTAT HEMOGLOBIN REAGENT TEST (K885227)Heraeus Kulzer, Inc.1989-02-24
ENDOTHELIAL GROWTH MEDIUM (EGM) (K890701)Clonetics Corp.1989-02-24
ATS LUGOL'S IODINE SOLUTION (K890020)Alpha-Tec Systems, Inc.1989-02-24
CP&S GAVAGE CONSTAINER, DISPOSABLE (K890552)Consolidated Products & Services, Inc.1989-02-24
HOLD-FAST DENTURE ADHESIVE (K884999)Iodent, Co.1989-02-24
BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT (K885241)King Mfg. Co.1989-02-24
WRIGHT-GLEMSA STAIN (K890673)Sigma Diagnostics, Inc.1989-02-24
MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD (K884688)Synthes (Usa)1989-02-24
MELANOCYTE GROWTH MEDIUM (MGM) (K890700)Clonetics Corp.1989-02-24
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (K890674)Sigma Diagnostics, Inc.1989-02-24
BIOTRACK APTT REAGENT CARTRIDGE (K890052)Biotrack, Inc.1989-02-24
CRIS ADAPTER (K883986)Y1989-02-24
MDP DISPOSABLE SYRINGE (K890155)Mediplas Marketing1989-02-24
KODAK MIN-R 2 CASSETTE (K890361)Eastman Kodak Company1989-02-24
CNS-8200A CENTRAL NURSES STATION (K884050)Nihon Kohden America, Inc.1989-02-23
JEDMED KP6 COLPOSCOPE (K884934)Jedmed Instrument Co.1989-02-23
VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER (K884949)Ortho Source1989-02-23
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (K885198)Icn Biomedicals, Inc.1989-02-23
KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR (K874778)Eastman Kodak Company1989-02-23
PATIENT MONITOR MODEL 701 (K884096)Ivy Biomedical Systems, Inc.1989-02-23
HEARTSTART 2000 DEFIBRILLATION ELECTRODE (K885186)Laerdal Mfg. Corp.1989-02-23
CARDIOBEEPER IV (K890461)Survival Technology, Inc.1989-02-23
THYROXINE MICROASSAY (K884260)Diamedix Corp.1989-02-23
SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (K890561)Atlantic Antibodies1989-02-23
TECA/MEDELEC 'CONCEPT' P420 (K884870)Teca, Inc.1989-02-23
LIFEPAK 10 DEFIBRILLATOR/MONITOR (K890079)Physio-Control Corp.1989-02-23
TITAN GEL ALKALINE PHOSPHATASE (HR) (K885341)Helena Laboratories1989-02-23
DELFIA PROGESTERONE KIT (K890428)Pharmacia, Inc.1989-02-23
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208 (K890298)Salter Labs1989-02-23
BP-408 MARK II (K884885)Colin Medical Instruments Corp.1989-02-23
HEMORRHAGE OCCLUDOR (K890447)Surgeon Surgical Instrumentation, Inc.1989-02-23
SIEMENS INTRAVAGINAL TRANSDUCER (K885061)Siemens Medical Solutions USA, Inc.1989-02-23
DRENOVAC (K883982)Iberhospitex, S.A.1989-02-23
SURGICAL GOWNS (K890474)Victoria Slipper Retail & Mfg., Co.1989-02-23
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Every clearance here is in the API, with alerts when new ones post.