Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SCISSORS GENERAL HOSPITAL (K844063)I M, Inc.1984-11-19
FACTOR IX DEFICIENT PLASMA, B9D - (K843215)Sigma Chemical Co.1984-11-19
MEDO MEDOMER MBF-100 II (K841235)Medo U.S.A., Inc.1984-11-19
SERIES I/S INFECTIONS (K844289)American Dade1984-11-19
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY (K844158)American Dade1984-11-19
FACTOR XI DEFICIENT PLASMA B11D (K843438)Sigma Chemical Co.1984-11-19
UNILOC (K842465)American Ortomed Corp.1984-11-19
J4 MYO-MONITOR (K842223)Myo-Tronics Research, Inc.1984-11-19
PHARMA-PLAST NASAL OXYGEN CANNULA (K843467)Zimmar Consulting , Ltd.1984-11-19
NEC-KRADLE BY VENCOR (K844239)Vencor1984-11-19
LENSKEEPER LENS CARRYING CASE (K843342)Allergan Pharmaceuticals, Inc.1984-11-19
FACTOR XII DEFICIENT PLASMA B12D (K843451)Sigma Chemical Co.1984-11-19
UNILYTE A (K843623)Medical Enterprises, Ltd.1984-11-16
FOAM CARE ONE STEP PREP (K843636)Ballard Medical Products1984-11-16
PERSONAL CL SINGLE-CHANNEL ELECTROCAR (K842123)Parexel Intl. Corp.1984-11-16
URITROL-M (K842808)The Washington Group, Inc.1984-11-16
HAP ACETABULAR CUP (K843190)Depuy, Inc.1984-11-16
PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (K843470)Zimmar Consulting , Ltd.1984-11-16
PERSONAL AMPLIFIER SILENCER (K843980)Electone, Inc.1984-11-16
TRANQUILITY (K843869)Principle Business Ent.1984-11-16
ASN MONITOR SINGLE NEEDLE MONITOR (K843531)Organon Teknika Corp.1984-11-16
STORZ ASPIRATION MACHINE SAM 5000 (K843644)Storz Instrument Co.1984-11-16
SCD STERILE CONNECTION DEVICE (K844144)E.I. Dupont DE Nemours & Co., Inc.1984-11-16
ARGYLE SILICONE CENTRAL VENOUS CATH- (K843450)Sherwood Medical Co.1984-11-15
OHMEDA PEEP VALVE FOR GMS ABSORBER (K843835)Ohmeda Medical1984-11-15
ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 (K843993)Southmedic, Inc.1984-11-15
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM (K844149)Ambu, Inc.1984-11-15
TITANIUM HIP 1019 (K843909)Depuy, Inc.1984-11-15
INTERMEDICS/GRASEBY DYNAMICS MS 36 (K843331)Intermedics, Inc.1984-11-15
AGGLUTINATION TEST FOR TOTAL IGE (K843369)Scientific Research1984-11-14
CRYO MASSAGE CUP (K843203)Cryo Therapy1984-11-14
LINK ACETABULAR MESH (K844225)Waldemar Link GmbH & Co. KG1984-11-14
MANDIBULATOR JAW POSITIONER (K843705)A Company, Inc.1984-11-14
VENT-A-CAST (K843780)Orthopedic Technology, Inc.1984-11-14
KANIEVSKI SENSORY AID OR DEVICE (K843433)Spectro Industries, Inc.1984-11-14
SIROGNATHOGRAPH (K843951)Siemens Medical Solutions USA, Inc.1984-11-14
DELTANODE, MEGA DELTA, DELTA LINK- (K843558)Computer Design & Applications, Inc.1984-11-13
TANDEM - EPRL (K843804)Hybritech, Inc.1984-11-13
UREA NITROGEN REAGENT SET (K844156)Livonia Diagnostics, Inc.1984-11-13
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT (K844045)Advanced Cardiovascular Systems, Inc.1984-11-13
CODE-A-WALL SERIES 1-250 INOCULUM TRAY (K844058)Plastic Injectors, Inc.1984-11-13
MICRO HEMATOCRIT CAPILLARY TUBES (K843892)Abco Dealers, Inc.1984-11-13
CANNULA INTRODUCER (K843118)Cardiovascular Research, Inc.1984-11-13
TRI-MED 610 CAPNOSTAT GAS ANALYZER (K843285)Tri-Med, Inc.1984-11-13
N-CHANNEL (K834212)Philips Medical Systems (Cleveland), Inc.1984-11-13
COULTER COUNTER MODEL ZM (K843164)Coulter Electronics, Inc.1984-11-13
POS COMBO PANEL (K844086)American Micro Scan1984-11-13
RIONET HEARING AID HB-73 (K844000)Rion Acoustic Instruments, Inc.1984-11-09
TRIGLYCERIDE REAGENT (K844032)Sigma Diagnostics, Inc.1984-11-09
TITAN GEL ISO DOT LDH KIT (K842669)Helena Laboratories1984-11-09
VOLUMATIC (K844169)Glaxo, Inc.1984-11-09
BEHIND-THE-EAR 123 VTH (K843791)Danavox, Inc.1984-11-09
A.S.P.C./CLEARSOUND (K842832)Asl, Inc.1984-11-09
SLS 3500 LED VISUAL STIMULATOR (K842381)Nihon Kohden America, Inc.1984-11-09
PERFOURM (K842324)Cutter Laboratories, Inc.1984-11-09
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS (K844047)Fisher Diagnostics1984-11-09
UNITEK CONVERTIBLE CAP REMOVER TOOL (K843742)Unitek Corp.1984-11-09
ORTHODONTIC WIRE (K843722)Arthur L. Wool1984-11-09
INORGANIC PHOSPHORUS REAGENT SET (K844182)Livonia Diagnostics, Inc.1984-11-09
SOLAR-GOLD UV-A BY EOS (K843902)Eos-Werke, Gunther GmbH1984-11-08
HU-FRIEDY IMS CASSETTE SYSTEM (K844002)Hu-Friedy Mfg. Co., Inc.1984-11-08
KETRONIC MEDAX - N (K843288)Ketronic, Inc.1984-11-08
EZ EYE DROP AID (K841896)Buckman Co., Inc.1984-11-08
COMFEEL POWDER (K834343)Coloplast A/S1984-11-08
PORTABLE NURSING UNIT TERMINAL (K841246)Ncr Corp.1984-11-08
TRANSFERSCREEN II (K843857)Erich Jaeger, Inc.1984-11-08
STENOSCOP (K843235)Cgr Medical Corp.1984-11-08
IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS (K842217)Micro Consultants, Inc.1984-11-08
ARM-A-VIAL LV HEATER-BREATHING SYS (K844005)Armour Pharmaceutical Co.1984-11-08
LUER LOCKING ADAPTER(MATERIAL CHANGE) (K840815)Quinton, Inc.1984-11-08
TPN/HYPERALIMENTATION TRAY (K842644)Deroyal Industries, Inc.1984-11-08
AQUAPHOR R GAUZE (K842967)Beiersdorf, Inc.1984-11-08
ISOLATE ADHESIVE BANDAGE FOR DRY WOUND (K843140)Chesebrough-Pond'S U.S.A. Co.1984-11-08
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND (K843139)Chesebrough-Pond'S U.S.A. Co.1984-11-08
COSGROVE MITRAL VALVE RETRACTOR (K844177)Kapp Surgical Instrument, Inc.1984-11-08
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS (K843966)American Medical Optics1984-11-08
CO2 SURGICAL LASER SYSTEM XML-10 (K841860)Xanar, Inc.1984-11-08
ASC 4080 SYSTEM (K843634)Atlantis Scientific Corp.1984-11-08
DUAL CHENNEL BRAIN ACTIVITY MONITOR (K843808)Datex Division Instrumentarium Corp.1984-11-08
SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT (K842690)Synectics AB1984-11-08
DORR HIP PROSTHESIS, ACETABULAR COMPON (K842893)Carbomedics, Inc.1984-11-08
LANCE BLADES & SCALPELS (K844001)Perry, Div.1984-11-08
COMFEEL ULCUS SHEET (K840438)Coloplast A/S1984-11-07
THE BIBICURE SYS DERMEPIL NATURAL HAIR (K843543)Les Entreprises Bibi, Inc.1984-11-07
HEMSTATS (K844152)I M, Inc.1984-11-07
DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI PADS (K843958)Tambrands, Inc.1984-11-07
DEODORANT REGULAR MAXITHINS BODY-SHAPED MAXI PADS (K843959)Tambrands, Inc.1984-11-07
COMFEEL PASTE (K840362)Coloplast A/S1984-11-07
SKIN-LITE (K843300)Guardian Chemical1984-11-07
ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET (K844199)Kleen Test Products1984-11-07
SCEPTOR BETA-LACTAM PLUS MIC PANEL (K844231)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-07
CUSTOM BURN DRESSING KIT (K843788)Hermitage Hospital Products, Inc.1984-11-07
DEODORANT MAXITHINS BODY-SHAPED PANTY SHIELDS (K843960)Tambrands, Inc.1984-11-07
SETS AND TRAYS (K844151)I M, Inc.1984-11-07
MODEL 305AA PORTABLE LASER (K841781)Laser Spectrum, Inc.1984-11-07
HYDROXYAPATITE (K842718)Depuy, Inc.1984-11-07
PORTABLE OXYGEN UNIT (K843691)B & F Medical Products, Inc.1984-11-07
AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON (K843345)Mira, Inc.1984-11-06
CREAT BRAND SKIN EXPANDER (K843678)Aesthetech Corp.1984-11-06
ARGON LASER PHOTOCOAGULATOR SYS (K843965)American Medical Optics1984-11-06
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Track 1984 automatically

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