Atlas FDA

1980

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

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RecordFirmDate
413A NEONATAL MONITOR (K800164)Xerox Corp.1980-04-10
BUN REAGENT KIT #88108 (K800616)Hi Chem, Inc.1980-04-10
ANT. & POST. RESTORATIVE POWDER LIQ. (K800390)American Dental Research1980-04-10
CATHETER STYLET (K800609)G.D. Searle and Co.1980-04-10
SNAP-WAY HEADGEAR (K800748)Northwest Orthodontics, Inc.1980-04-10
BRACKET BONDING SYSTEM METAL & PLASTIC (K800392)American Dental Research1980-04-10
D668 & D664 CENTRAL MONITORING SYSTEMS (K800243)Medtel Pty. , Ltd.1980-04-10
POLY SULFIDE IMPRESSION PASTE W/CATALYST (K800393)American Dental Research1980-04-10
HYDRAGAMMA 16 (K800601)Innotron of Oregon, Inc.1980-04-10
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D (K800604)Beckman Instruments, Inc.1980-04-10
PAINT-ON-RESTORATIVE W/FISSURE SEALER (K800391)American Dental Research1980-04-10
C.C.-PAK (K800635)Respiratory Care, Inc.1980-04-10
MJ PERCUSSOR (K800713)Cussionair Therapy Products, Inc.1980-04-10
PORTABLE MEDICAL ULTRASOUND SCANNER (K800434)Bion Ent., Ltd.1980-04-10
ANTERIOR & POST. RESTORATIVE PASTE SYS. (K800389)American Dental Research1980-04-10
CENTRIFI CHEM AST/SGOT (K800641)Union Carbide Corp.1980-04-10
S.K. DIAG. ULTRASOUND BODY SCANNER (K800532)Smithkline Diagnostics, Inc.1980-04-10
MEDICAL COMPONENTS IV CATHETER (K800525)Medical Components, Inc.1980-04-08
BOUGIE A BOULE (K800611)G.D. Searle and Co.1980-04-08
CYBERLITH IMPLANTABLE PULSE GEN. #253-04 (K800645)Intermedics, Inc.1980-04-08
SEARS ALL-IN-THE-EAR HEARING AID #8149HF (K800447)Int'L Hearing Aids, Inc.1980-04-08
STONE DISLODGER (K800608)G.D. Searle and Co.1980-04-08
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM (K800330)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-08
PROBE (K800729)Stainless Mfg., Inc.1980-04-08
RETROGRADE KNIFE (K800730)Stainless Mfg., Inc.1980-04-08
URETHRAL SOUND (K800610)G.D. Searle and Co.1980-04-08
SEARS ALL-IN-THE-EAR HEARING AID #8149 (K800446)Int'L Hearing Aids, Inc.1980-04-08
DISP. HYDROGEN & CO2 GENERATOR ENVELOPE (K800539)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-08
STOMACH TUBES (K800508)Medi-Craft , Ltd.1980-04-08
COMBISON COMPUTER (K800092)Kt Medical, Inc.1980-04-08
FEEDING TUBES (K800507)Medi-Craft , Ltd.1980-04-08
WATER CONDUCTIVITY MONITOR & CONTROLLER (K800305)Darco Water Systems, Inc.1980-04-08
SUPRAPUBIC TROCAR (K800607)G.D. Searle and Co.1980-04-08
MARK II (K800662)Applied Science Laboratories1980-04-08
SYRINGE INFUSION PUMP #2720 (K800569)Harvard Apparatus, Inc.1980-04-08
BETA-ASE TUBES (K800579)Microchemical Specialities, Co.1980-04-08
PULSEOMETER (K800500)Kirklands Sporting Goods Co.1980-04-08
RECTAL & HARRIS FLUSH TUBES (K800510)Medi-Craft , Ltd.1980-04-08
HEMODIALYSIS CONCENTRATE SOLUTION (K792513)Mid Atlantic Nephrology Center1980-04-08
SUR-FIT UROSTOMY POUCH & URINARY BAG (K800495)E. R. Squibb & Sons, Inc.1980-04-08
SCHILLER MSG-1 (K800659)Renesco International, Inc.1980-04-08
DOUBLE-EDGE CURETTE (K800733)Stainless Mfg., Inc.1980-04-08
RUDD-CLINIC HEMORRHOIDAL FORCEPS (K800441)J. Sklar Mfg. Co., Inc.1980-04-08
MARK III (K800663)Applied Science Laboratories1980-04-08
LOW PLASTICIZER ADMINISTRATION SETS (K791496)Travenol Laboratories, S.A.1980-04-08
CAMBRIDGE VS-550 ELECTROCARDIOGRAPH (K800566)Cambridge Instruments, Inc.1980-04-08
MENISCOTOME (K800732)Stainless Mfg., Inc.1980-04-08
URETHRAL CATHETER (K800505)Medi-Craft , Ltd.1980-04-08
ANGIOPLASTY INJECTOR (K800613)Medrad, Inc.1980-04-08
MENISCAL SAW (K800731)Stainless Mfg., Inc.1980-04-08
MODIFIED CATHETER PACKAGE (K800703)Hancock Laboratories, Inc.1980-04-08
MODEL S/D-600 AUTO INFLATE CONTROL MODUL (K800661)Applied Science Laboratories1980-04-08
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION (K800425)Gambro, Inc.1980-04-08
ANTIMICROBIAL REMOVAL DEVICE (ARD) (K800052)Marion Laboratories, Inc.1980-04-04
HEMATO-CHEX (K800361)Streck Laboratories, Inc.1980-04-04
COMPUR M-1000 MINI-PHOTOMETER (K800059)Miles Laboratories, Inc.1980-04-04
PARTNER SEVEN DISP. BUBBLE OXYGENATOR (K800555)Cardiovascular Research, Inc.1980-04-04
NSI CARBON DIOXIDE REAGENT KIT (K800586)Nobel Scientific Industries, Inc.1980-04-04
CAMPYLOBACTER AGAR W/5-ANTIMICROBICS (K800541)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-04
BACTOGEN-H. INFLUENZAE TYPE B (K800493)Armkel, LLC1980-04-04
NSI CALIBRATOR SET (K800588)Nobel Scientific Industries, Inc.1980-04-04
TLS TM SURGICAL DRAINAGE SYSTEM (K800581)Glasrock Products, Inc.1980-04-04
VENTRE/SEP CORTISOL RIA (K800594)Ventrex Laboratories, Inc.1980-04-04
KRYMED LIQUID NITROGEN CRYOJET (K800335)Cryomedics, Inc.1980-04-04
ADD OF RETICULOCYTE COUNT/CAPABILITIES (K800533)Abbott Laboratories1980-04-04
3M DISPOSABLE SKIN STAPLER (K800535)3M Company1980-04-04
GLUCOSE OXIDASE REAGENT (K800589)Nobel Scientific Industries, Inc.1980-04-04
BUN KIT (K800590)Nobel Scientific Industries, Inc.1980-04-04
TRANSPHOR TM LD LACTATE DEHYDROGENASE (K800568)Corning Medical & Scientific1980-04-04
SCHLEIN TRI-SURFACE ANKLE (K800530)Orthopedic Equipment Co., Inc.1980-04-02
CONTOUROGRAPH M-500 (K800591)Bio-Tek Instruments, Inc.1980-04-02
SERALYZER REFLECTANCE PHOTOMETER/CALIB. (K800524)Miles Laboratories, Inc.1980-04-02
FIBERGLASS CYLINDER BASES, #'S 65040- (K800665)B & F Medical Products, Inc.1980-04-02
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM (K800650)Hospal Medical Corp.1980-04-02
REUSABLE HAND-TROL (K800597)Aspen Laboratories, Inc.1980-04-02
ADDITIONAL COMPONENTS KRONNER COMPRES (K800502)Richard F. Kronner, M.D.1980-04-02
KDA MICRO CHEMICAL ANALYZER (K800572)American Monitor Corp.1980-04-02
ANA LATEX SLIDE TEST (K800605)Biologics Intl., Inc.1980-04-02
SHUTRAK (K800132)Moore Business Forms, Inc.1980-04-02
TYPE 4000 TRANSCUTANEOUS ELEC. STIM. (K800630)Frye Electronics, Inc.1980-04-02
LIPASE DETERMINATION (K800550)The Dow Chemical Co.1980-04-02
OXYMETER (K800631)Dragerwerk AG1980-04-02
100 ML SNYDER HEMOVAC (K800542)Snyder Laboratories, Inc.1980-04-02
NSI CHLORIDE REAGENT KIT (K800585)Nobel Scientific Industries, Inc.1980-04-02
NSI CREATININE KIT (K800583)Nobel Scientific Industries, Inc.1980-04-02
SIRECUST 311S (K800593)Siemens Corp.1980-04-02
NSI SODIUM/POTASSIUM KIT (K800584)Nobel Scientific Industries, Inc.1980-04-02
MT-10, ET-20 (K800251)Associated Mills, Inc.1980-04-02
NEUROMETRICS MONITOR (K800452)Neurometrics1980-04-02
OHIO DISPOSABLE TRACHEAL TUBE (K800634)Ohio Medical Products1980-04-02
SURE FLOW TUBING (K800664)B & F Medical Products, Inc.1980-04-02
PERCUTANEOUS CATHETER INTRODUCER (K800580)Alva Medical, Inc.1980-04-02
CINOXACIN 100 MCG SENSI DISC (K800540)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-02
MEDTEK #411 PORTABLE B-P INSTR. (K800614)Med-Tek Corp.1980-04-02
OXIDE ANAEROBIC SYSTEM (K800430)Oxoid U.S.A., Inc.1980-04-02
FERRIS MODIFIED DISP. IL STERNAL-ILIAC (K800413)A.D.T. Lab Industries1980-03-25
ADT NERVE BLOCK TRAY(DISP.) (K800423)A.D.T. Lab Industries1980-03-25
ADT MENGHINI TYPE SOFT TISSUE BIOPSY (K800415)A.D.T. Lab Industries1980-03-25
OXYGEN CATHETER (K800506)Medi-Craft , Ltd.1980-03-25
DVT PREVENTION SYS. MBE 22 PRESSURE U. (K800337)Med-Bio Engineering, Inc.1980-03-25
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