Atlas FDA

1989

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

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RecordFirmDate
BACTIGEN(R) S. PNEUMONIAE (K884966)Armkel, LLC1989-02-07
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0 (K885289)Eastman Kodak Company1989-02-07
MODIFIED D-DI-TEST KIT (K890399)American Bioproducts Co.1989-02-07
BACTIGEN(R) MENINGITIDIS PANEL (K884965)Armkel, LLC1989-02-07
JEHLE CORONARY PERFUSION CATHETERS (K884946)Pilling Co.1989-02-06
MODEL 8700 PULSE OXIMETER (K890033)Nonin Medical, Inc.1989-02-06
GLOVE, SURGICAL (K884425)Med-Pak Corp.1989-02-06
GRAFT GUARD (K885136)Sorex Medical1989-02-06
MODEL 499 SSR ANALYSIS SYSTEM (K884887)Del Mar Avionics1989-02-06
ARBO PINK H82P (K884775)Arbo Medical, Inc.1989-02-06
A10 ULTRASCOPE RECORDER (K890142)Ems Medical, Inc.1989-02-06
AL-800PA PULSE OXIMETER MODULE (K884536)Nihon Kohden America, Inc.1989-02-06
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE (K884895)Advanced Cardiovascular Systems, Inc.1989-02-06
SUPREME TONING SYSTEMS (K885095)Supreme Toning Systems1989-02-06
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN (K890191)Amersham Corp.1989-02-06
SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 (K890059)Sharplan Lasers, Inc.1989-02-06
MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY (K885188)Quinton, Inc.1989-02-06
ORTHOTRAK (K890076)Motion Analysis Corp.1989-02-03
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG (K890326)Howmedica Corp.1989-02-03
RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER (K883845)Phoenix Imaging1989-02-03
STERILE & NON-STERILE SURGEONS GLOVES (K882200)Taroko Ent., Ltd.1989-02-03
ABDOMINAL SPATULA (K890374)Kinetic Medical Products1989-02-03
PNEUMATIC DORSIFLEXOR (K890200)Medical Flotation Systems, Inc.1989-02-03
HOLDER, NEEDLE (K890167)Dhason Brothers, Inc.1989-02-03
SCISSORS (K890170)Dhason Brothers, Inc.1989-02-03
SPINETRAK (K890074)Motion Analysis Corp.1989-02-03
BIOFEEDBACK DEVICE TG3, TG4 (K884851)Moe1989-02-03
COULTER CLONE T3 MONOCLONAL ANTIBODY (K883710)Coulter Immunology1989-02-03
ELECTRA 900C AUTOMATIC COAGULATION TIMER (K884863)Medical Laboratory Automation Systems, Inc.1989-02-03
KODAFLEX II RADIATION THERAPY L CASSETTE (K885178)Eastman Kodak Company1989-02-03
MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT (K890091)Labsystems, Inc.1989-02-03
BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE (K883776)Btc Corp.1989-02-03
MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES (K885291)Pfizer Laser Systems1989-02-03
TOWEL CLIPS (K890159)Dhason Brothers, Inc.1989-02-03
KIDNEY CLAMP (K890368)Kinetic Medical Products1989-02-03
COULTER CLONE B4 MONOCLONAL ANTIBODY (K884020)Coulter Immunology1989-02-03
PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) (K890034)American Monitor Corp.1989-02-03
THE BREATHE EASE NURSERY VAPOR TENT (K884922)Cal-Trends Products1989-02-03
KOAGULAB* 32-S COAGULATION SYSTEM (K885035)Ortho Diagnostic Systems, Inc.1989-02-03
INTESTINAL CRUSHING CLAMP (K890371)Kinetic Medical Products1989-02-03
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K884180)Unipath , Ltd.1989-02-03
ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (K884026)Oxoid U.S.A., Inc.1989-02-03
LATEX SURGICAL GLOVE (NON STERILE) (K883556)Makintech Corp.1989-02-03
LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ (K884731)Amdev, Inc.1989-02-03
PF TEST (K884513)Medi-Tech, Inc.1989-02-03
HANDIDAM (K884828)Aseptico, Inc.1989-02-03
PRECISE ILA AND ILAN SURGICAL STAPLES (K885222)3M Company1989-02-03
IMMUNODOT TORCH TEST RUBELLA (K884898)General Biometrics, Inc.1989-02-03
DRESSING SCISSORS (K890235)Kinetic Medical Products1989-02-03
HEMORRHOIDAL FORCEPS (K890373)Kinetic Medical Products1989-02-03
INTESTINAL CLAMP (K890372)Kinetic Medical Products1989-02-03
INTRAVASCULAR ADMINISTRATION SET (K890127)Multi-Med, Inc.1989-02-03
OLYMPUS ISE MODULE (K885193)Olympus Corp.1989-02-03
ADENOID CURETTE (K890366)Kinetic Medical Products1989-02-03
PARAMETRIUM CLAMP (K890381)Kinetic Medical Products1989-02-03
GALL STONE FORCEPS (K890369)Kinetic Medical Products1989-02-03
COULTER CLONE T1 MONOCLONAL ANTIBODY (K883753)Coulter Immunology1989-02-03
SEPTUM ELEVATOR (K890365)Kinetic Medical Products1989-02-03
THE BOOSTER (K860698)Knapps Corp.1989-02-03
WHEELCHAIR, MECHANICAL (K885330)Kaye Products, Inc.1989-02-03
LUMINEB I (K884722)Lumiscope Co., Inc.1989-02-03
COONRAD III TOTAL ELBOW (K883665)Zimmer, Inc.1989-02-03
FACE MASK (K890016)Anjudd Intl.1989-02-03
FOOTTRAK (K890075)Motion Analysis Corp.1989-02-03
TU SUCTIONTRAP (K884944)Tulan Corp. C/O Richard Hamer Assoc.1989-02-03
T-UPTAKE MICROASSAY (K885034)Diamedix Corp.1989-02-02
BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30 (K884850)Moe1989-02-02
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN (K885144)Heraeus Kulzer, Inc.1989-02-02
CLINISTAT SGOT (AST) REAGENT TEST (K885156)Heraeus Kulzer, Inc.1989-02-02
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION (K884742)Medical Data Electronics1989-02-02
BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV (K884848)Moe1989-02-02
SOURCERER (K884091)John Caunt Scientific , Ltd.1989-02-02
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY (K884617)Ortho Diagnostic Systems, Inc.1989-02-02
IMMUNODOT RUBELLA TEST (K885082)General Biometrics, Inc.1989-02-02
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (K890350)Telectronics, Inc.1989-02-02
PATIENT MONITOR MODEL 703 (K884662)Ivy Biomedical Systems, Inc.1989-02-02
BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1 (K884853)Moe1989-02-02
DADE PROTEIN C CHROMOGENIC ASSAY (K884881)Baxter Healthcare Corp1989-02-02
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (K884886)The Perkin-Elmer Corp.1989-02-02
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY (K884816)Diasonics, Inc.1989-02-02
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 (K884546)Em Diagnostic Systems, Inc.1989-02-02
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY (K884794)Serono-Baker Diagnostics, Inc.1989-02-02
PATIENT MONITOR RIGEL MODEL MULTICARE 429 (K884645)Rigel Medical Electronics, Inc.1989-02-02
GLUCOSE-SUPER FAST 4983050 AND 4983500 (K882262)American Research Products Co.1989-02-02
BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. (K884852)Moe1989-02-02
PACH-PEN CALCULATOR (K884619)Oculab, Inc.1989-02-02
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO (K884901)Baxter Healthcare Corp1989-02-02
AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (K881857)Spectramed, Inc.1989-02-01
CATH-FINDER SYSTEM (K884701)Pharmacia Deltec, Inc.1989-02-01
LACEY POSTERIOR STABILIZED KNEE SYSTEM (K884338)Dow Corning Wright1989-02-01
MVL/MODULAB WITH PVR MODULE (K884624)Life Sciences Manufacturing, Inc.1989-02-01
EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. (K884614)Edentec Corp.1989-02-01
MICROVASIVE GOLD PROBE (K885005)Boston Scientific Corp1989-02-01
COI 24 HR COLLAGEN SHIELD (K885016)Chiron Ophthalmics1989-02-01
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM (K882999)Organon Teknika Corp.1989-01-31
HYDROTONE I (K890308)Hydrotonics Therapy Corp.1989-01-31
RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS (K883748)Kawasumi Laboratories Co., Ltd.1989-01-31
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 (K884554)Baxter Healthcare Corp1989-01-31
TRUDELL BENT CATHETER (K885167)Sil-Med Corp.1989-01-31
CUDDLE UP PILLOW (K882544)Ohio Medical Instrument Co., Inc.1989-01-31
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