Atlas FDA

1989

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

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RecordFirmDate
SHAMROCK SAFETY WINGED INFUSION SET (K895481)Ryan Medical, Inc.1989-10-10
GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM (K893537)Greenleaf Medical Systems, Inc.1989-10-10
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID (K894189)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-10
BIOTRACK PDS MONITOR (K895102)Biotrack, Inc.1989-10-10
POW-IR TIP (K895073)Living Technology, Inc.1989-10-10
AMMEL PATIENT EXAMINATION GLOVES (K894502)Mauricio Menconi1989-10-10
ARGOS (K895127)Abx, Inc.1989-10-10
PT DISTAL TIP CEMENT SPACER (K894708)Osteonics Corp.1989-10-10
ABNORMAL REFERENCE PLASMA-VIII (K895503)Medical Diagnostic Technologies, Inc.1989-10-06
DEVILBISS MODEL 8500D AND 8500D-608 (K894244)Devilbiss Health Care, Inc.1989-10-06
FIRST CHOICE (TM) (K893205)Polymer Technology Corp.1989-10-06
MITEK ANCHOR DRILL (K892903)Mitek Surgical Products, Inc.1989-10-06
HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE (K895105)Waters Chemical Products1989-10-06
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT (K895255)Medical Diagnostic Technologies, Inc.1989-10-06
AUTOMIX 3+3 COMPOUNDER (K894827)Baxter Healthcare Corp1989-10-06
ABNORMAL REFERENCE PLASMA-IX (K895504)Medical Diagnostic Technologies, Inc.1989-10-06
OHMEDA MODULUS CD ANESTHESIA SYSTEM (K894309)Ohmeda Medical1989-10-06
ROCKET BONE MARROW NEEDLE (K895551)A & A Medical, Inc.1989-10-06
HEMATOLOGY CONTROL (K895373)Medical Specialties Intl., Inc.1989-10-06
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR (K894365)Puritan Bennett Corp.1989-10-06
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR (K892885)Fisher & Paykel Electronics , Ltd.1989-10-06
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM (K892228)Intermedics Orthopedics1989-10-06
ORTHO *APO A-1 ELISA TEST SYSTEM (K895160)Medical Marketing Consultants, Inc.1989-10-06
S.S.T. SURGICAL THIMBLE (K895603)Healthcare Technologies Resources, Inc.1989-10-06
TECHNOMED PULSOLITH LASER SYSTEM (K895178)Teknomed, Inc.1989-10-06
INTRAVENOUS EXTENSION SET (K895367)Medical Product Specialists1989-10-06
MARK IV HAND, THUMB AND WRIST (CPM) UNIT (K894907)Innovative Medical Engineering, Inc.1989-10-06
UNDER BUTTOCKS DRAPE (K895404)Medical Plastics, Inc.1989-10-06
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (K895594)Go Medical Industries Pty. , Ltd.1989-10-06
PERIODONTAL IRRIGATING SOLUTION-D (K894247)Dentsply Intl.1989-10-06
SPECTRASTIM TM 1000 (K893964)Therapeutic Technologies, Inc.1989-10-06
ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) (K895261)Medical Diagnostic Technologies, Inc.1989-10-06
BIOTRACK ALT TEST CARTRIDGE (K895128)Biotrack, Inc.1989-10-06
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) (K895260)Medical Diagnostic Technologies, Inc.1989-10-06
NORMAL COAGULATION CONTROL PLASMA (NCCP) (K895262)Medical Diagnostic Technologies, Inc.1989-10-06
THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM (K895527)Quantitative Technologies, Inc.1989-10-06
SECOND GENERATION KNEE SYSTEM (K894334)Orthomet, Inc.1989-10-06
ABL500 BLOOD GAS SYSTEM (K895181)Radiometer America, Inc.1989-10-06
STERILE ULTRASOUND TRANSMISSION GEL (K894490)Swedish Trade Council USA1989-10-05
SHARPLAN MODEL 710 MICROSPOT (K895746)Sharplan Lasers, Inc.1989-10-05
MODEL 285 INFUSION PUMP (K894321)3M Company1989-10-05
LATEX PATIENT EXAMINATION GLOVES (K894453)Mittal Meditex Pvt. , Ltd.1989-10-05
FORTRESS 2000FS 3-WHEEL SCOOTER (K895693)Fortress Scientific , Ltd.1989-10-05
SONOLINE CF (K891449)Siemens Ultrasound, Inc.1989-10-05
LIFECARE PRESSURE ALARM CAT. NO. 34-010 (K894361)Lifecare Services, Inc.1989-10-05
SIEMENS ENDO-P-PROBE (K894806)Siemens Medical Solutions USA, Inc.1989-10-05
FORTRESS 655FS POWER WHEELCHAIR (K895595)Fortress Scientific , Ltd.1989-10-05
ATTENUATING SURGICAL GLOVE (K891315)F & L Medical Products Co.1989-10-05
BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR (K892841)Bedfont Technical Instruments , Ltd.1989-10-05
THE ORIGINAL PULSE-PAK (K892639)Jones Sales Co.1989-10-05
EXTACISER PERINEAL MUSCLE EXERCISER (K892888)Bivona Medical Technologies1989-10-05
IRIS OCULIGHT(TM) SL (K894841)Iriderm Div.1989-10-05
GYNECOLOGIC EXAMINATION KIT (K894489)A & A Medical, Inc.1989-10-05
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST (K895339)Immco Diagnostics, Inc.1989-10-04
NIL PATIENT EXAMINATION GLOVES (K895641)United Lion Rubber Industries Sdn. Bhd.1989-10-04
PATIENT EXAMINATION GLOVES (K892998)Shen Yunn Plastics Corp.1989-10-04
DELFIA PLATE FLUOROMETER 1232 (K895240)Pharmacia, Inc.1989-10-04
TARGET OPIATES-V (K890979)V-Tech, Inc.1989-10-04
WOLDOFF PRISMATIC BICONCAVE LENS (K894421)Ocular Instruments, Inc.1989-10-04
PRO-JECT(TM) SAFETY NEEDLE HOLDER (K892665)Pro-Tec Containers, Inc.1989-10-04
PATIENT EXAMINATION GLOVES (K892996)Multiplus Trading , Ltd.1989-10-04
ACCESS CHEMISTRY ANALYZER (K895423)American Monitor Corp.1989-10-04
QCLYTE PROTEIN-BASED ISE CONTROL (K895582)Baxter Healthcare Corp1989-10-04
TECHNICON RA SYSTEM THYROXINE T4 METHOD (K894575)Technicon Instruments Corp.1989-10-04
DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER (K884915)Dantec Electronics, Inc.1989-10-04
GIPHY MONITOR (K883960)Vascular Technology Incorporated1989-10-04
LATEX EXAMINATION GLOVES (K894677)Kumpulan Santra (Penang) Sdn. Bhd.1989-10-04
OSSEODENT SURGICAL KIT (K894331)Collagen Corp.1989-10-04
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. (K895484)Baxter Healthcare Corp1989-10-04
CALCIUM (ARSENAZO III) REAGENT (K894204)Sigma Diagnostics, Inc.1989-10-04
NIDEK MODEL ADC-8000 (K894709)Nidek, Inc.1989-10-04
MASCOT EXAMINATION GLOVES (K894587)Mascot, Inc.1989-10-04
MODEL 280 INFUSION PUMP (K894360)3M Company1989-10-04
PATIENT EXAMINATION GLOVES (LATEX) (K892609)Commfields (M) Sdn. Bhd.1989-10-04
PATIENT EXAMINATION GLOVES (LATEX) (K892608)Grand Design Sdn. Bhd.1989-10-04
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL (K895474)Canon USA, Inc.1989-10-04
LATEX EXAMINATION GLOVES (K895332)Ever Glory Intl., Inc.1989-10-04
MODEL 480 INFUSION PUMP (K894320)3M Company1989-10-04
ORTHO RESULT PLUS/PREGNANCY (K894420)Ortho Diagnostic Systems, Inc.1989-10-04
THERMALGRAPHIC ANALYSER (K894772)Medtech Instruments1989-10-03
STERILE SALINE - FOR SUCTION CATHETER LUBRICATION (K895039)Aplicare, Inc.1989-10-03
BIOPSY FORCEPS (K892252)Zinnanti Surgical Instruments, Inc.1989-10-03
VAS-CATH URETERAL STENT CATHETER (K894357)Vas-Cath, Inc.1989-10-03
SELECTRODE (K894920)S & W Medico Teknik1989-10-03
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42 (K895221)Siemens Medical Solutions USA, Inc.1989-10-03
MEDICAL DYNAMICS LIGHT SOURCE (K894319)Medical Dynamics, Inc.1989-10-03
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR (K892396)Biometer Intl. A/S1989-10-03
FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER (K895694)Fortress Scientific , Ltd.1989-10-03
GX-ELEVATOR (K894188)Gendex Corp.1989-10-03
ERGOMED 840/ERGOMED 840L (K885085)Burdick Corp.1989-10-03
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT (K894394)Abbott Laboratories1989-10-03
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE (K893958)Span-America Medical Systems, Inc.1989-10-03
PEDI-TUBE(R) STYLET (K894857)Biosearch Medical Products, Inc.1989-10-03
SALTER LABS MODEL #4009 SAMPLE LINES (K894350)Salter Labs1989-10-03
CARDIOBEEPER MEMORY MONITOR CB 600 SERIES (K894799)Survival Technology, Inc.1989-10-03
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE (K894791)Span-America Medical Systems, Inc.1989-10-03
SYRINGE INJECTION GUN DELIVERY KITS (K890658)Gastrotech, Inc.1989-10-03
VALPROIC ACID (FPIA) KIT (K895569)Tudor Laboratories, Inc.1989-10-03
THERMOSURGERY TM (K894166)Rdm Intl., Inc.1989-10-03
PCI MODEL 2041-A TELEMETRY MONITOR (K894340)Accucore, Inc.1989-10-02
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Track 1989 automatically

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