Atlas FDA

1989

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

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RecordFirmDate
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. (K895583)Gen-Probe, Inc.1989-11-14
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. (K894711)Gen-Probe, Inc.1989-11-14
POWERED EYE WASH (K893829)Sacks Model Makers1989-11-14
TOTAL BILIRUBIN L.F. (K895822)Sclavo, Inc.1989-11-14
SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY (K894471)Surgilase, Inc.1989-11-14
QUANTIMETRIX BILIRUBIN CALIBRATORS (K895778)Quantimetrix Medical Industries1989-11-14
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 (K896028)American Research Products Co.1989-11-14
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD (K895664)Technicon Instruments Corp.1989-11-14
SELDINGER PERCUTANEOUS 2 PC NEEDLES (K895455)Advance Medical Designs, Inc.1989-11-14
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI (K893041)Telectronics Pacing Systems, Inc.1989-11-14
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) (K895585)Hichem Diagnostics1989-11-13
MODIFIED SPANTRON FRAME FREEZE (K895546)Spantron, Inc.1989-11-13
MOBILE X-RAY TELEVISION UNIT WHA-10A/B (K895394)Shimadzu Corp.1989-11-13
ABBOTT IMX IGE (K895914)Abbott Laboratories1989-11-13
TDX(R) LITES(TM) LITHIUM (K894328)Abbott Laboratories1989-11-13
ALANINE AMINOTRANSFERASE (ALT) (K896001)American Monitor Corp.1989-11-13
MODIFIED HOMECLINIC PREGNANCY TEST (K895560)Vanguard Biomedical Corp.1989-11-13
API UNISCEPT KB (K895796)Analytical Products, Inc.1989-11-13
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) (K895251)C.R. Bard, Inc.1989-11-13
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (K896321)Superior Healthcare Group, Inc.1989-11-13
RADKOR DXG-650R (K895969)Radkor, Inc.1989-11-13
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (K895123)Advanced Technology Laboratories, Inc.1989-11-13
CARDS O.S. (TM) HCG-URINE (K895390)Pacific Biotech, Inc.1989-11-13
.22 & 1.2 MICRON IV FILTERS (K894954)Churchill Medical Systems, Inc.1989-11-13
ALKALINE PHOSPHATASE, LEUKOCYTE, KIT (K896092)Sigma Chemical Co.1989-11-09
PARA TECH FOR TECHNICON H-1 (K896154)Streck Laboratories, Inc.1989-11-09
FIBRINOGEN ASSAY KIT (K896052)Medical Diagnostic Technologies, Inc.1989-11-09
CROSS CANCELLOUS BONE SCREW (K896044)Buckman Co., Inc.1989-11-09
PROMONTORY STIMULATING ELECTRODE (K895081)Cadwell Laboratories, Inc.1989-11-09
RAPIDEC STAPH (K891004)Dms Products, Inc.1989-11-09
DAVOL ARTHROSCOPY CANNULA (K894990)Davol, Inc.1989-11-08
WAKO(TM) AUTOKIT GAMMA-GT (K895984)Wako Chemicals USA, Inc.1989-11-08
DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID) (K895686)Stand-N-Go Corp.1989-11-08
ULTRACOMPACT (K894968)Eutectic Electronics, Inc.1989-11-08
SHANNON LATEX MEDICAL GLOVES (K895804)Cashmor Mfg. , Ltd.1989-11-08
REFLUX BED (K896256)Cozcon, Inc.1989-11-08
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS (K894715)Catachem, Inc.1989-11-08
NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856)Acacia Laboratories, Inc.1989-11-08
HUMAN (IGG) SUBCLASS (EIA) KIT (K895600)The Binding Site, Ltd.1989-11-08
CEDIA DIGITOXIN ASSAY (K896021)Microgenics Corp.1989-11-08
SURGI-BRUSH (K896085)Sparta Surgical Corp.1989-11-08
DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST (K894106)Cd Medical, Inc.1989-11-08
LATEX EXAMINATION GLOVES (K893350)Pan Africa Exports , Ltd.1989-11-08
NF-1 MINDPEACE (K895175)Neurofitness1989-11-08
LASERMATIC COMBOLASER MODEL 5050 (K895279)Lasermatic OY1989-11-08
THE ON-GARD RECAPPER (K895220)On-Gard Systems, Inc.1989-11-08
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 (K892443)Gish Biomedical, Inc.1989-11-08
TRANSDUCER PROTECTOR (K895281)Filtertek, Inc.1989-11-08
HDL SINGLES (K895381)Trace America, Inc.1989-11-08
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H (K895759)National Medical Care, Medical Products Div., Inc.1989-11-08
FIAGEN T3 UPTAKE CATALOGUE #101-402 (K895186)Cyberfluor, Inc.1989-11-08
QUANTAI UG REAGENT STRIP (K893661)Quantai Biotronics, Inc.1989-11-08
COMA COCAINE METABOLITE ASSAY (EIA) (K895043)Serex, Inc.1989-11-08
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) (K896271)Biokit USA, Inc.1989-11-08
THE DOCTOR'S CHOICE ELECTRODE (K895737)The Skin Care Centre1989-11-08
ONE TOUCH II METER (K895911)Lifescan, Inc.1989-11-08
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL (K896272)Biokit USA, Inc.1989-11-08
ASNIS II GUIDED BONE SCREW (K895766)Howmedica Corp.1989-11-08
LATEX EXAMINATION GLOVES (K895552)Jung Hua Co.1989-11-08
SURGEON'S GLOVES (K896327)Productes Del Latex, S.A.1989-11-08
BLOOD GAS SAFETY SYRINGE (K895171)Kronner Medical1989-11-07
LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP) (K894194)Invent Ent. (U.S.A.) Corp.1989-11-07
LATEX EXAMINATION GLOVES (K893804)S-P Pantec Co., Ltd.1989-11-07
HEIMLICH MICRO TRACH (K895130)Ballard Medical Products1989-11-07
PATIENT EXAMINATION GLOVES (LATEX) (K892571)Sinopac Marketing, Inc.1989-11-07
PATIENT EXAMINATION GLOVES (LATEX) (K892076)M/S Shanghai Knitwear Import & Export Corp.1989-11-07
INTRASITE CAVITY WOUND DRESSING (K895354)Smith & Nephew United, Inc.1989-11-07
WESTCO MADAYAG PAB NEEDLE (K894387)Western Medical, Ltd.1989-11-07
LATEX PATIENT EXAMINATION GLOVES (K894967)Yan Ling Rubber Products Co.1989-11-07
PATIENT EXAMINATION GLOVES (K891182)Raystar Engineering & Construction Sdn Bhd1989-11-07
PATIENT EXAMINATION GLOVES (K893075)Quality Latex Corp. Sdn Bhd1989-11-07
STIMTRAC II CATALOG NUMBER 78-8500 (K895671)Stimtech Products1989-11-06
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES (K895996)Lipogen, Inc.1989-11-06
MODEL 410T TELECOMMUNICATION SYSTEM (K895045)Ge Medical Systems Information Technologies1989-11-06
PEMACO 2000 INTRAORAL DENTAL WAX (K895562)Pemaco, Inc.1989-11-06
AVL MODEL 912 CO-OXYLITE (K895466)Avl Scientific Corp.1989-11-06
PEMACO 3000 INTRAORAL DENTAL WAX (K895561)Pemaco, Inc.1989-11-06
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER (K895026)Hewlett-Packard Co.1989-11-06
ARROW HANDS-OFF THERMO-PACE (K895268)Arrow Intl., Inc.1989-11-06
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 (K884651)Biomedical Life Systems, Inc.1989-11-06
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE (K890044)Biopro, Inc.1989-11-06
X-RAY EQUIPMENT (VARIOUS TYPES) (K895730)Continental X-Ray Corp.1989-11-06
BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES (K895725)Interson Corp.1989-11-06
ULTRANET-S COLLIMATOR (K894142)GE Medical Systems1989-11-06
MODIFIED QM300 ALBUMIN ANTIBODY PACK (K896059)Kallestad Diag, A Div. of Erbamont, Inc.1989-11-06
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES (K895997)Lipogen, Inc.1989-11-06
ULTIMA XS MICROCURRENT TENS (K895295)American Imex1989-11-06
TOITU FETAL ACTOCARDIOGRAPH, MT-332 (K894036)Toitu of America, Inc.1989-11-06
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K894514)Alamar Biosciences Laboratory, Inc.1989-11-06
PATIENT POSITIONING ACCESSORIES (K895500)Perkins Mfg. Co.1989-11-06
PEMACO BITE WAX SHEETS (K895563)Pemaco, Inc.1989-11-06
THERASTIM (K893851)Physiodynamics, Inc.1989-11-06
PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (K895566)Pemaco, Inc.1989-11-06
CCO SYSTEM MODEL SP1467,SP5567,SP6267 (K892941)Spectramed, Inc.1989-11-06
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM (K893744)Shimadzu Medical Systems1989-11-06
PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD (K895564)Pemaco, Inc.1989-11-06
ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST. (K893821)Kinamed, Inc.1989-11-06
STRAPPED EYE SHIELD (K896172)Eye Garter Company, Inc.1989-11-03
EYE PATCH (K896171)Eye Garter Company, Inc.1989-11-03
MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES (K890665)Dyonics, Inc.1989-11-03
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Track 1989 automatically

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