Atlas FDA

1980

2,857 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MEASLES VIRUS & CONTROLS (K802932)Orion Diagnostica, Inc.1980-12-31
DISPOSABLE DIAPHRAGM DONE (K803011)Sorensen Research1980-12-31
MUMPS S & V ANTIGENS & CONTROLS (K802933)Orion Diagnostica, Inc.1980-12-31
SELECTIVE CHARCOAL YEAST EXTRACT AGAR (K802758)Remel Co.1980-12-31
HERPES SIMPLEX TYPE I (K802939)Orion Diagnostica, Inc.1980-12-31
ORTHO HEMOTOLOGY CONTROL-NORMAL (K803083)Ortho Instruments1980-12-31
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & (K802936)Orion Diagnostica, Inc.1980-12-31
PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (K802935)Orion Diagnostica, Inc.1980-12-31
ORTHO HEMATOLOGY CONTROL (K803073)Ortho Instruments1980-12-31
RUBELLA VIRUS ANTIGENS & CONTROLS (K802937)Orion Diagnostica, Inc.1980-12-31
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW (K803084)Ortho Instruments1980-12-31
ADENO VIRUS & CONTROLS (K802929)Orion Diagnostica, Inc.1980-12-31
MOIST HEAT PACK (K803177)Duro-Med Ind., Inc.1980-12-31
SARNS INFANT ARTERIAL BUBBLE SENSOR (K803105)3M Health Care, Sarns1980-12-31
UCLA SHOULDER (K801970)Howmedica Corp.1980-12-31
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (K802934)Orion Diagnostica, Inc.1980-12-31
ZIMMER ELECTRICAL MUSCLE STIMULATOR (K803064)Zimmer, Inc.1980-12-31
ACETABULAR CEMENT COMPRESSOR (K803165)Zimmer, Inc.1980-12-31
BEHIND-THE-EAR HEARING AID (K802859)Danavox, Inc.1980-12-31
WISCONSIN BONE MINERAL ANALYZER (K802181)Lunar Radiation Corp.1980-12-31
VARICELLA-ZOSTER ANTIGENS & CONTROLS (K802938)Orion Diagnostica, Inc.1980-12-31
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT (K802268)R&D Systems, Inc.1980-12-31
WISCONSIN DUAL-PHOTON BONE ANALYZER (K802180)Lunar Radiation Corp.1980-12-31
TRANSDUCER DOME, CAT.#SD-101 (K802961)Sorensen Research1980-12-31
NUVOX BEDSIDE TINNITUS MASKER (K802750)Hal-Hen Co., Inc.1980-12-31
SHUR-PATCH TAPE PATCH (K803012)Shur Medical Corp.1980-12-30
JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS (K802988)Swiss American Metal Craft Corp.1980-12-30
MEISINGER DIAMOND DENTAL BURS (K802984)Swiss American Metal Craft Corp.1980-12-30
MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT (K803113)George H. Frisch1980-12-30
LARGE WOUND DRESSING KIT (K803119)American Medical Disposable, Inc.1980-12-30
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. (K803016)Helena Laboratories1980-12-30
DISPERSALLOY-DISPERSED PHASE ALLOY SELF- (K802967)Johnson & Johnson Professionals, Inc.1980-12-30
JOTA DIAMOND DENTAL BURS (K802987)Swiss American Metal Craft Corp.1980-12-30
HEMESPEC II (K803015)Helena Laboratories1980-12-30
RODEL ELECTRODERM PADS (K802658)Rodel Products Corp.1980-12-30
MENTOR 150 TRANSCUTANEOUS NERVE STIMULA (K803121)George H. Frisch1980-12-30
MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. (K802989)Swiss American Metal Craft Corp.1980-12-30
HIGH FREQUENCY AUDIOMETER DELMAR #20-K (K803072)Demlar Medical, Inc.1980-12-30
CONPHAR PERCUSSION HAMMER(BUCK TYPE) (K803174)Conphar, Inc.1980-12-30
ROLL STRETCH GAUZE (K802991)Abco Dealers, Inc.1980-12-30
SPRAY, SYNTHETIC SMEAR (K803050)Laboratory Products, Inc.1980-12-30
SERUM FREE TISSUE CULTURE MEDIA (K803041)Cartaya Assoc.1980-12-30
THE INQUINAL RESORVOIR INSERTER (K802983)Lone Star Medical Products, Inc.1980-12-30
PROXIMATE*II DISPOSABLE SKIN STAPLER (K803038)ETHICON, Inc.1980-12-30
ELASTIC GAUZE (K802992)Abco Dealers, Inc.1980-12-30
ECG & ULTRASOUND GELS, CREAMS & LOTION (K803151)Abco Dealers, Inc.1980-12-30
CUSTOM DRESSING TRAY WET TO DRY (K803117)American Medical Disposable, Inc.1980-12-23
MYCOLOGY CULTURE SYSTEM (K802946)Orion Diagnostica, Inc.1980-12-22
EMERG. OXYGEN KIT #65350 & #65399 CASE (K802644)B & F Medical Products, Inc.1980-12-22
PROFILE CARDIAC SET ASSAYED SERUM CONTR. (K803036)General Diagnostics1980-12-22
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER (K803059)Extracorporeal Medical Specialities, Inc.1980-12-22
MICRO THIN-PII, #0523 (K802353)Cardiac Pacemakers, Inc.1980-12-22
SHELL KRATON THERMO-PLASTIC RUBBER COMP. (K803069)Warren E. Collins, Inc.1980-12-22
ENRICHED THIOGLYCOLLATE MEDIUM (K803023)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-12-22
FOLEY CATHETER (K803079)American Hospital Supply Corp.1980-12-22
THE BIO-TEK CHROMOSCAN (K803030)Bio-Tek Instruments, Inc.1980-12-22
HDL-CHOLESTEROL CONTROL SERUM (K802997)Isolab, Inc.1980-12-22
SERALYZER LDH REAGENT STRIPS, CALIBR (K803019)Miles Laboratories, Inc.1980-12-22
ELECATH FLUID-DRAIN ASSEMBLY (K803002)Electro-Catheter Corp.1980-12-22
PLASTIC FRACTURE CAST BRACE KNEE JOINT (K802910)Orthomedics1980-12-22
DIGOXIN & PHENYTOIN CONTROL SERA (K803097)Amersham Corp.1980-12-22
VANCE UROSTOMY APPLIANCE (K803048)Vance Products, Inc.1980-12-22
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (K803045)American Dade1980-12-22
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S (K803042)Siemens Elema AB1980-12-22
MIC-BIOPLATE INOCULATOR (K803092)Pasco Laboratories, Inc.1980-12-22
TLC SUPPORT PRODUCTS (K803029)Orthopedic Systems, Inc.1980-12-22
MICROTHIN-PII BIPOLAR PULSE GEN. #0623 (K803034)Cardiac Pacemakers, Inc.1980-12-22
ADHESIVE PERISTOMAL COVERING W/WO CONN. (K803082)Johnson & Johnson Professionals, Inc.1980-12-22
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN (K802884)Corning Medical & Scientific1980-12-22
I-125 LABELED DIGOXIN (K803047)Pcl-Ria, Inc.1980-12-22
KERATOPLASTY SUTURING LENS (K802593)Paris Contact Lens Laboratory1980-12-22
PRO-OPHTA STICKS (K802794)Secol Co.1980-12-22
CRUSADER HYPEREXTENSION BRACE (K803033)Orthomedics1980-12-22
HYPERALIMENTATION DRESSING CHANGE TRAY (K803114)American Medical Disposable, Inc.1980-12-22
TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL (K802994)Sacks Farms Biological Products1980-12-22
INTRAJECT (K802332)General Medical Engineering Corp.1980-12-22
GAMBRO LUNDIA PLATE DISP. DIALYZER (K802389)Gambro, Inc.1980-12-22
DIGOXIN RIABEAD DIAGNOSTIC KIT (K803075)Abbott Laboratories1980-12-22
HELENA AT-III QUIPLATE PROCEDURE (K802912)Helena Laboratories1980-12-22
APEXLINE OF PULMONARY FUNCT. INSTRUM. (K803053)Warren E. Collins, Inc.1980-12-22
CDC ANAEROBE BLOOD AGAR (K803025)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-12-22
CDC ANAEROBE LAKED BL AGAR W/PARAMOMY. (K803024)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-12-22
COBE CENTRY 2 VARIABLE CONCENTRATE-18- (K802895)Cobe Laboratories, Inc.1980-12-22
SENSOMAT (K803014)Biochem International, Inc.1980-12-22
MICROTHIN-PII BIPOLAR PULSE GEN. #0621 (K803035)Cardiac Pacemakers, Inc.1980-12-22
PEPTONE YEAST EXTRACT GLUCOSE BROTH (K803026)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-12-22
ARTERIAL BUBBLE TRAP K-20 (K803102)Delta Medical Industries1980-12-22
ORICULT DTM (K802947)Orion Diagnostica, Inc.1980-12-22
FOLATE 125I RADIOIMMUNOASSAY (K803060)Corning Medical & Scientific1980-12-22
CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC. (K803027)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-12-22
CHEM-ASSAY STANDARD-CONTROLS (K802962)National Bio-Technical Laboratories1980-12-22
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. (K803039)General Diagnostics1980-12-22
BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP (K802230)Cardio Med Supplies, Inc.1980-12-22
AMES TDA AMIKACIN CONTROL SERUM (K803107)Miles Laboratories, Inc.1980-12-22
ALL PUPOSE URETHRAL CATHETER (K803080)American Hospital Supply Corp.1980-12-22
PATIENT CARE DISPOSABLE INFANT SHIRTS (K802998)American Convertors Div., American Pharmaseal1980-12-22
QUANTIMUNE E3 RIA (K802944)Bio-Rad1980-12-22
PREBYPASS FILTER CAT.#K-5 (K803101)Delta Medical Industries1980-12-22
TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL (K802995)Sacks Farms Biological Products1980-12-22
BETA-TEC QUALITATIVE (K802999)Armkel, LLC1980-12-22
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Track 1980 automatically

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