Atlas FDA

1989

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

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RecordFirmDate
TYPE 9140 (SYSTEM ATHENA) (K894699)S & W Medico Teknik1989-10-02
MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE (K894445)Mallinckroot, Inc.1989-10-02
VISION WHOLE BLOOD HDL CHOLESTEROL (K895158)Abbott Laboratories1989-10-02
DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM (K894834)Brymill Corp.1989-10-02
HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM (K893094)Heartware Intl. Corp.1989-10-02
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE (K891451)Olympus Corp.1989-10-02
MODEL DS-504 DYNASCOPE PATIENT MONITOR (K893405)Fukuda Denshi USA, Inc.1989-10-02
FUKUDA DENSHI MODEL FCP-2201 (K892796)Fukuda Denshi USA, Inc.1989-10-02
AP-851PA NIBP MODULE (K894693)Nihon Kohden America, Inc.1989-10-02
TYPE PDU/CDU 9040 (SYSTEM ATHENA) (K894700)S & W Medico Teknik1989-10-02
BEDSIDE MONITORS, BSM-8301A, BSM-8302A (K894692)Nihon Kohden America, Inc.1989-10-02
SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA (K894460)Siemens Medical Electronics1989-10-02
COLONIC BALLOON DIALATORS (K884713)Primrose Medical, Inc.1989-09-29
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS (K885229)Romano Surgical Instrumentation, Inc.1989-09-29
SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE (K891481)Siemens Medical Electronics1989-09-29
URETHRAL AND URETERAL BALLOON DILATATORS (K884711)Primrose Medical, Inc.1989-09-29
PATIENT EXAM GLOVES(MFG: JIN DING ZAI JIE LATEX GL (K893696)Double Scores , Ltd.1989-09-29
ACHELASIA BALLOON DIALATOR (K884715)Primrose Medical, Inc.1989-09-29
CADWELL FREEDOM EEG DEVICE (K894276)Cadwell Laboratories, Inc.1989-09-29
FIBER OPTIC LIGHT TRANSMISSION CABLE (K892145)Opto Vision, Inc.1989-09-29
UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM (K894337)Vitaid, Ltd.1989-09-29
BIO-INDUSTRY STIM POCHE(R) (K894786)The Hader Corp.1989-09-29
BILIARY DIALATOR (K884714)Primrose Medical, Inc.1989-09-29
EXCEL LATEX PATIENT EXAMINATION GLOVES (K895494)Alpha Glove Sdn. Bhd.1989-09-29
CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD (K894409)Amersham Corp.1989-09-29
DENVER PERITONEO-VENUS SHUNT (K894756)Codman & Shurtleff, Inc.1989-09-29
TRU-TRAX (K894851)Humagen, Inc.1989-09-29
PATIENT EXAMINATION GLOVES (LATEX) (K891341)A.P. Rubber Co., Ltd.1989-09-29
LATEX GLOVE, EXAMINATION (K893726)Lixin Hygienical Products Factory Co., Ltd.1989-09-29
PRENATAL WEDGE (K895343)Kay Ent.1989-09-29
ROSCO PYRR (K894221)Pro-Lab, Inc.1989-09-28
DELTATEST (R) LIPASE II (K893718)Electro-Nucleonics, Inc.1989-09-28
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 (K894765)Laser Industries , Ltd.1989-09-28
PLUME-AWAY SMOKE EVACUATION SYSTEM (K894038)Laser Technologies Group, Inc.1989-09-28
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) (K894310)American Research Products Co.1989-09-28
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL (K894222)Abbott Laboratories1989-09-28
OPSITE I.V. 3000 (K895353)Smith & Nephew United, Inc.1989-09-28
BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (K895207)Johnson & Johnson International1989-09-28
KIT- CIBA CORNING L-TDM I, II, III (K893682)Ciba Corning Diagnostics Corp.1989-09-28
BILIBLANKET PHOTOTHERAPY DEVICE (K894129)Ohmeda Medical1989-09-28
ACL DRILL GUIDE SYSTEM (K892655)Baxter Healthcare Corp1989-09-28
PRIMIDONE (FPIA) CALIBRATOR KIT (K895568)Tudor Laboratories, Inc.1989-09-28
VARI-SET (K894111)Sonex Medical1989-09-28
BIO-COORDINATOR SYSTEM (K895398)Bio-Harmonizer, Inc.1989-09-28
LATEX EXAMINATION GLOVES (K894193)Hasil Getah Gulungan Pertama1989-09-28
COAT-A-COUNT(TM) FENTANYL (TKFN1) (K891605)Diagnostic Products Corp.1989-09-28
OBTURATOR (K894157)Argon Medical Corp.1989-09-28
CO2 LASER BRONCHOSCOPE COUPLER (K894962)Cuda Products Co.1989-09-28
FPR GENTAMICIN KIT (K894523)Colony Laboratories, Inc.1989-09-28
EZ-BEAD DIGOXIN EIA KIT (K893843)Immunotech Corp.1989-09-28
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) (K894804)Lifescan, Inc.1989-09-28
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE) (K891588)Ideal Medical, Inc.1989-09-28
NIPRO NEEDLE HOLDER (K894372)Pharma-Plast USA, Inc.1989-09-28
VALPROIC ACID (FPIA) CALIBRATOR KIT (K895570)Tudor Laboratories, Inc.1989-09-28
EXUSORB(TM) GRANULES (K894996)Controlled Therapeutics Corp.1989-09-28
MILENIA(TM) TOTAL IGE (MKIE1,5) (K895004)Diagnostic Products Corp.1989-09-28
PATIENT EXAMINATION GLOVES (LATEX) (K892586)Modlook Industries , Ltd.1989-09-28
BLOOD DRAWING NEEDLE (K894374)Pharma-Plast USA, Inc.1989-09-28
FPR AMIKACIN KIT (K894517)Colony Laboratories, Inc.1989-09-28
FPR GENTAMICIN CALIBRATOR KIT (K894524)Colony Laboratories, Inc.1989-09-28
HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL (K894160)Artech Corp.1989-09-28
MITEK DRILL GUIDE (K892904)Mitek Surgical Products, Inc.1989-09-28
FPR AMIKACIN CALIBRATOR KIT (K894518)Colony Laboratories, Inc.1989-09-28
TARGET THERAPEUTICS TRACKER LF CATHETER (K894105)Target Therapeutics1989-09-28
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS (K894852)Instrumentation Laboratory CO1989-09-28
MODIFIED GEMINI ACETABULAR CUP (K894298)Depuy, Inc.1989-09-27
SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY (K895042)Sharplan Lasers, Inc.1989-09-27
VOSS GRAFT MARKER (K895369)Voss Medical Products1989-09-27
TIK EXTRAKTOR (K895212)Instruments of Sweden, Inc.1989-09-27
LATEX PATIENT EXAMINATION GLOVES (K895258)Perfect Treasure Development , Ltd.1989-09-27
COUNTERBORE FOR SS SUBMERGED SCREW PLANT (K894150)Artech Corp.1989-09-27
PREEMICARE MODEL 2500 TRANSPORT WARMER (K893624)Preemicare Corp.1989-09-27
HEARING AID (IN-THE-CANAL) (K894414)Hearing Aid Express1989-09-27
WAKO(TM) AUTOKIT CRP (K895598)Wako Chemicals USA, Inc.1989-09-27
ORTHO APO B ELISA TEST SYSTEM (K895277)Medical Marketing Consultants, Inc.1989-09-27
SECONDARY IV SET WITH PROTECTED NEEDLE (K895109)Kendall Mcgaw Laboratories, Inc.1989-09-27
SURGICAL SUCTION APPARATUS (K895670)Baker-Sundt Research, Inc.1989-09-27
IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT (K894151)Artech Corp.1989-09-27
PATIENT EXAMINATION GLOVES (LATEX) (K892635)P.T. Multi Latexindo1989-09-27
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ (K894487)Y1989-09-27
COMFEEL TRANSPARENT DRESSING (K894916)Coloplast A/S1989-09-26
ORIENT, LATEX EXAMINATION GLOVES (K895558)Rosa Intl.1989-09-26
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD (K894138)Medipart Jerry Alexander1989-09-26
FIRST IMPRESSION WITH CHLORHEXIDINE (K894281)Coe Laboratories, Inc.1989-09-26
SWED MED STERILE VINYL EXAMINATION GLOVES (K893017)New England Glove Company1989-09-26
MINIMON 7137B PATIENT MONITOR (K895425)Kontron Instruments, Inc.1989-09-26
PATIENT EXAMINATION GLOVES (K892505)Wango Intl., Inc.1989-09-26
EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS (K890597)D-R Medical Systems, Inc.1989-09-26
DMI PC HOLTER SCANNER (K894285)Diagnostic Medical Instruments1989-09-26
IMX TOTAL B-HCG (K894182)Abbott Laboratories1989-09-26
LATEX EXAMINATION GLOVES (K893336)Lai Sun Industrial Co.1989-09-26
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING (K893471)Medtronic Vascular1989-09-26
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO (K894343)Daig Corp.1989-09-26
OPUS MODEL 4001 (K894065)Ela Medical, Inc.1989-09-26
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH (K892530)Arrow Intl., Inc.1989-09-26
SAFETY TOUCH VINYL EXAMINATION GLOVES (K893105)Fedin Brothers Co., Inc.1989-09-26
LEONARDO INFORMATION SYSTEM (K894426)Hamilton Medical, Inc.1989-09-26
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP (K894255)St. Jude Medical, Inc.1989-09-26
PATIENT LATEX EXAMINATION GLOVES (K894758)Agrimal Industries Sdn. Bhd.1989-09-26
'JOBSTAR' PATIENT EXAMINATION GLOVES (K892972)Kai Sik Towa Rubber Products Sdn1989-09-26
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Every clearance here is in the API, with alerts when new ones post.