Atlas FDA

1984

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

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RecordFirmDate
TSH QUIK RIA KIT (K843545)Pacific Biotech, Inc.1984-10-02
ESOPHAGEAL DILATOR SET (K842679)Mill-Rose Laboratory1984-10-02
DIAFLEX NEPHROSTOMY BALLOON DILATOR (K842206)American Edwards Laboratories1984-10-02
METER MOUSE SYSTEM (K842599)Mem, Inc.1984-10-02
LASER FOR GENITOURINARY APPLIC. 4000 (K843240)Cooper Lasersonics, Inc.1984-10-02
DIFFERENTIATION DISKS NITRATE (K843521)Difco Laboratories, Inc.1984-10-02
DORR HIP PROSTHESIS FEMORAL COMPONENT (K842360)Carbomedics, Inc.1984-10-02
ND-YAG LASER FOR PALLIATION OF GI MALIGN (K843374)Endo Lase, Inc.1984-10-02
AMIZYME-C TRACHOMATIS TEST KIT (K842525)Amico Lab, Inc.1984-10-01
EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (K843286)Immuno-Mycologics, Inc.1984-10-01
MICROMEDICS SURGICAL INSTRUMENTS (K842212)Micromedics, Inc.1984-10-01
FORMALIN BUFFERED (K842982)Reagent Laboratory, Inc.1984-10-01
BACTO STAPHYLOCOCCUS LATEX TEST (K843560)Difco Laboratories, Inc.1984-10-01
EPSILON HCG TEST KIT MONOCLONAL (K842654)Beckman Instruments, Inc.1984-10-01
VON WILLEBRAND FACTOR ANTIGEN SCREEN (K842537)American Dade1984-10-01
BONE SCREWS (K843554)Mecron Medical Products, Inc.1984-10-01
ENCORE IGE REAGENT (K843408)Hybritech, Inc.1984-10-01
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE (K842121)E-Z-Em, Inc.1984-10-01
AMERICAN MEDICAL OPTICS I/A KIT- IRRIG (K842197)American Medical Optics1984-10-01
BONE PLATES (K843553)Mecron Medical Products, Inc.1984-10-01
AMER. MEDICAL OPTICS DIGITAL KERATO- (K842504)American Medical Optics1984-10-01
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT (K842617)American Dade1984-10-01
BIOLAS YAG 100 CILAS, ERCELAS YAG 100 (K843156)Advanced Biomedical Instruments1984-10-01
RIM-UREA (K843571)Austin Biological Laboratories1984-10-01
TOOTH ROOT SOCKET GAUGE (K843154)Interpore Intl.1984-10-01
ANTI-CHLAMYDIA TRACHOMATIS KIT (K842658)Amico Lab, Inc.1984-10-01
SUR-FIT IRRIGATION ADAPTER FACEPLATE (K842398)Convatec, A Division of E.R. Squibb & Sons1984-10-01
WELLINGTON HOSPITAL PATTERN SELF-RETAIN (K843388)Downs Surgical , Ltd.1984-10-01
HYCEL DILUTOR, VARIOUS MODELS/MULTI (K842747)R&D Systems, Inc.1984-10-01
TOTAL PROTEIN REAGENT SET (K843701)Livonia Diagnostics, Inc.1984-10-01
GORE-TEX VASCULAR GRAFT, FEP-RINGED (K842144)W. L. Gore & Associates, Inc.1984-10-01
FETAL BOVINE SERUM, F4884 STERILE GROWT (K843629)Sigma Chemical Co.1984-10-01
SYSTEMATE A AMYLASE HEM 67204 (K843645)Em Diagnostic Systems, Inc.1984-09-28
FIAX 420 DILUTOR (K843621)Intl. Diagnostic Technology1984-09-28
ISO-SEP SYSTEM (K842018)Berwick Medical Products, Inc.1984-09-28
VMA ASSAY KIT (K843379)Diagnostic Chemicals, Ltd. (Usa)1984-09-28
PDA GLUCOSE (K843541)Abbott Laboratories1984-09-28
MATCHED COMPONENT SET FOR RADIOIMMUNO- (K843635)Cambridge Medical Technology1984-09-28
TITAN GEL ISO DOT CPK PROCEDURE (K842755)Helena Laboratories1984-09-28
PDA CHOLESTEROL (K843510)Abbott Laboratories1984-09-28
QUALIFY I & II AMER. MONITOR 2009 & 2010 (K843611)American Monitor Corp.1984-09-28
PRECISET AMMONIA (K843569)Boehringer Mannheim Corp.1984-09-28
LEECO CORTISOL-QUANT (K843384)Leeco Diagnostics, Inc.1984-09-28
CREATININE ASSAY KIT (K843377)Diagnostic Chemicals, Ltd. (Usa)1984-09-28
GLUCOSE AUTO& STAT GA-1120 (K843003)Kyoto Diagnostics, Inc.1984-09-28
ENZYMATIC CHOLESTEROL KIT (K843222)Livonia Diagnostics, Inc.1984-09-28
EMIT 700 CONTROL SET B (K843508)Syva Co.1984-09-28
GLUCOSE OXIDASE ENZYMATIC REAGENT SET (K843528)Livonia Diagnostics, Inc.1984-09-28
H.P.T. HOME PREG. TEST KIT & A.P.T. (K834474)Biomedical Research & Development Laboratories, Inc.1984-09-28
EOSIN Y 1% ALCOHOLIC (K843426)Accra Laboratories, Inc.1984-09-27
RELIANCE TREATMENT CABINET (K843046)F. & F. Koenigkramer1984-09-27
STABILIZING RETAINER (K843143)Dental Advancements, Inc.1984-09-27
ANDROSTENEDIONE BY RIA (K842960)Radioassay Systems Laboratories, Inc.1984-09-27
FLOW CONTROLLER (K843223)Precision Medical, Inc.1984-09-27
INSTRUMENTS FOR MICRO ANASTOMOSIS (K843100)Downs Surgical , Ltd.1984-09-27
MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE (K843314)Smith & Nephew, Mpl Division1984-09-27
EMIT 700 PHENCYCLIDINE ASSAY (K843509)Syva Co.1984-09-27
MK 700 ULTRASOUND SYSTEM (K842093)Advanced Technology Laboratories, Inc.1984-09-27
CLEAR LINER (K842576)Harry J. Bosworth Co.1984-09-27
COMMAND ULTRASEAL PIT & FISSURE SEALANT (K843024)Kerr Corporation (Danbury)1984-09-27
DENTAL CHAIR (K843436)Swedish Dental Products, Inc.1984-09-27
FLEXI-POST (K843018)Essential Dental Systems, Inc.1984-09-27
TPS SCREW DENTAL IMPLANTS (K843218)Artech Corp.1984-09-27
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK (K843341)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-27
BIOFIX (K843428)Accra Laboratories, Inc.1984-09-27
MEDICALEX (K833377)Medicalex1984-09-27
PROGRAMMABLE STIMULATOR 5326 (K843718)Medtronic Vascular1984-09-27
URINE TRANSPORT KIT (K843359)Applied Polytechnology, Inc.1984-09-27
BOSWORTH SUPER BOND DENTAL ADHESIVE (K842448)Harry J. Bosworth Co.1984-09-27
ISO-DATA IMMUNOASSAY NETWORK SYSTEM (K843365)Iso-Data, Inc.1984-09-27
KERR GELLED PHOSPHORIC ACID ETCHANT (K843026)Kerr Corporation (Danbury)1984-09-27
ANTERIOR ALVEOLAR RIDGE SIZER (K843153)Interpore Intl.1984-09-27
STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ (K843452)Fisher Scientific Co., LLC1984-09-27
EMIT D.A.U. BENZODIAZEPINE ASSAY (K842815)Syva Co.1984-09-26
C-SECTION TRAY (K842627)Deroyal Industries, Inc.1984-09-26
THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (K842585)Windsor Laboratories, Inc.1984-09-26
EMIT D.A.U. OPIATE ASSAY (K842677)Syva Co.1984-09-26
TRICON-P TIBIAL COMPONENT (K843241)Richards Medical Co., Inc.1984-09-26
PHENYTOIN KIT FLUORESCENCE POLARIZATION (K842586)Windsor Laboratories, Inc.1984-09-26
ELECTRONIC EPILATOR TS-1 (K843063)R. A. Fischer Co. Corp.1984-09-26
ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER (K843460)Varian Assoc., Inc.1984-09-26
TRIGLYCERIDES GPO REAGENT (K843552)Bio-Rad1984-09-26
EMIT 700 CALIBRATOR B (K843507)Syva Co.1984-09-26
TRICON M TIBIAL COMPONENT (K843242)Richards Medical Co., Inc.1984-09-26
SURGITEK RECONSTRUC-NIPPLE PROSTHESIS (K842748)Medical Engineering Corp.1984-09-26
EMIT D.A.U. AMPHETAMINE ASSAY (K842674)Syva Co.1984-09-26
EMIT D.A.U. METHADONE ASSAY (K842676)Syva Co.1984-09-26
BRIMFIELD CANNULATED MAGNETIC RETRIEVER (K843135)Brimfield Scientific Instruments1984-09-26
ACCUSCREEN TSH (K843281)Neometrics, Inc.1984-09-26
EMIT D.A.U. BARBITURATE ASSAY (K842675)Syva Co.1984-09-26
STRATUS LIDOCAINE FLUOROMETRIC ENZYME (K843184)American Dade1984-09-26
EMIT 700 CANNABINOID CALIBRATOR (K843420)Syva Co.1984-09-26
BRIMFIELD CANNULATED GRASPING HOOKS (K843136)Brimfield Scientific Instruments1984-09-25
AUTO SUTURE SURGICLIP DISPOS. CLIP APPL (K843312)United States Surgical, A Division of Tyco Healthc1984-09-25
MEDICAL DIAG. ULTRASOUND INSTR. 77065 (K842897)Hewlett-Packard Co.1984-09-25
T.O.D. PLATE SYSTEM (K842681)Kirschner Medical Corp.1984-09-25
T.O.D. PLATE SYS STERILE (K842695)Kirschner Medical Corp.1984-09-25
EMIT 700 CANNABINOID ASSAY (K843421)Syva Co.1984-09-25
DANIELL DBL PUNCTURE LASER LAPAROSCOPY (K842498)Laser Spectrum, Inc.1984-09-25
THE CLINICIAN (K842574)Solidstate Systems Corp.1984-09-25
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Every clearance here is in the API, with alerts when new ones post.