Atlas FDA

1980

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

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RecordFirmDate
VASCULAR CATHETER WIREGUIDES (K802260)Stanco Medical, Inc.1980-10-10
CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT (K802163)Panmed, Inc.1980-10-10
REAGENTS SERUM CREATINE USING TECHICON (K802156)Panmed, Inc.1980-10-10
WIDEX HEARING AID #'S A12+T & A12+H (K802307)Hearing Aid Co.1980-10-10
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP) (K801841)American Hospital Supply Corp.1980-10-10
NU-BORN BABY BATH KIT (K802366)American Hospital Supply Corp.1980-10-10
TORQUE CONTROL BALLOON CATHETER (K802338)Cordis Corp.1980-10-10
ARTERIAL BLOOD SAMPLING KIT (K802185)Current Technologies, Inc.1980-10-10
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS (K802159)Panmed, Inc.1980-10-10
MINOCYCLINE 30 MCG. SENSITIVITY DISCS (K802178)Difco Laboratories, Inc.1980-10-10
AMERICAN MONITOR MAGNESIUM #'S 1036&4021 (K802091)American Monitor Corp.1980-10-10
DELTA TEST TRIGLYCERIDES (K802136)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-10
CO2 MICROSURGICAL LASER SYSTEM #370 (K802034)Metricon, Ltd.1980-10-10
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN (K802233)Helena Laboratories1980-10-10
TESTOSTERONE RADIOIMMUNOASSY KIT (K802135)Radioimmunoassay, Inc.1980-10-10
AO FLEXIBLE LARYNGOSCOPE, #LS-7 (K802331)American Optical Corp.1980-10-10
POSTASSIUM BUFFER SOL. & WASH SOLUTION (K802158)Panmed, Inc.1980-10-10
OREIA-Q-DIG (K802358)Organon, Inc.1980-10-10
AQUASONIC 100 ULTRASOUND TRANS. GEL, (K802146)Parker Laboratories, Inc.1980-10-10
ANTI-DS/N-DNA TEST KIT (K801960)Immuno-Diagnostic Products, Inc.1980-10-10
BEDSIDE TINNITUS MASKER #1500 (K802234)Marpac, Inc.1980-10-10
MLC-4200 CARDIAC OUTPUT COMPUTER (K802305)Nihon Kohden America, Inc.1980-10-10
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL (K802141)American Dade1980-10-10
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON (K802282)Consolidated Medical Equipment, Inc.1980-10-10
SPECIMEN SET (K802340)American Pharmaseal Div. Ahsc1980-10-10
7 TRICYCLIC ANTIDE PRESSANTS (K802245)Technicon Instruments Corp.1980-10-10
PRESSURE MONITORING LINES (K802326)Stanco Medical, Inc.1980-10-10
S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX (K801860)Pennwalt Corp.1980-10-10
REAGENTS SERUM SODIUM USING THE TECH. (K802155)Panmed, Inc.1980-10-10
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO (K802068)Beckman Instruments, Inc.1980-10-10
PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO (K802343)Intl. Diagnostic, Inc.1980-10-10
AMPCO SKIN SCRUB TRAY (K802375)Associated Medical Products Co.1980-10-10
VIALON SURGEON'S GLOVES (K802027)Rivefain Corp.1980-10-10
ANTERIOR KYPHOSIS DISTRACTION DEVICE (K802222)Zimmer, Inc.1980-10-10
HEMOTEMP TM (K802319)Marion Laboratories, Inc.1980-10-10
DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (K802328)Stanco Medical, Inc.1980-10-10
ORTHO SPECTRUM (K802094)Ortho Instruments1980-10-10
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI (K801964)American Pharmaseal Div. Ahsc1980-10-10
WHIRLPOOL BATHING UNIT-#2001 (K802335)Aqua Care Corp.1980-10-10
STERILE TONSIL SPONGES (K802060)Medspec Corp.1980-10-10
RF-II TEST KIT (K801961)Immuno-Diagnostic Products, Inc.1980-10-10
AIR VIVA II (K802231)General Medical Co.1980-10-10
BED ROCKING DEVICE (K801517)Wesler1980-10-10
KEMTROL SERUM CONTROL ABNORMAL (K802109)Helena Laboratories1980-10-10
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL (K802142)American Dade1980-10-10
SERO STREP KIT (K801775)Sacks Farms Biological Products1980-10-10
CUSTOM UNIVERSAL CUTDOWN PREP TRAY (K801965)American Pharmaseal Div. Ahsc1980-10-10
BAKER DIAG. ULTRARATE CHLORIDE KIT (K802080)J.T. Baker Chemical Co.1980-10-10
BUN COLOR REAGENT & BUN ACID USED (K802160)Panmed, Inc.1980-10-10
URIC ACID DIAGNOSTIC REAGENT (K801898)Connecticut Diagnostics, Ltd.1980-10-10
CO2 COLOR REAGENT & CO2 SAMPLE DILUENT (K802162)Panmed, Inc.1980-10-10
BCG REAGENT SERUM ALBUMIN W/TECHNICON (K802157)Panmed, Inc.1980-10-10
DRESSING CHANGE SET CAT.#910-930 (K802017)Pollak (Intl.), Ltd.1980-10-10
E1 SERIES HEARING AID (K802324)Western Advanced Technology, Inc.1980-10-10
GORE-TEX VASCULAR GRAFT (K802095)W. L. Gore & Associates, Inc.1980-10-10
WHITE KNIGHT BOVIE CORD/SUCTION TUBE (K802213)G.D. Searle and Co.1980-10-10
SELF-RECORDING ADMITTANCE METER 709 (K802097)Amplaid USA, Inc.1980-10-10
IN-HOME EARLY PREGNANCY TEST KIT (K802334)Health Diagnostics Corp.1980-10-10
KOTEX LIGHTDAYS DEODORANT PANTILINERS (K802277)Kimberly-Clark Corp.1980-10-10
BIURET REAGENT & TOTAL PROTEIN BLANK SOL (K802161)Panmed, Inc.1980-10-10
QUICK PRIME LINES, #'S BPL-12, BPL-48 & (K802378)Bentley Laboratories, Inc.1980-10-10
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET (K802143)American Dade1980-10-10
ALGINATE IMPRESSION MATERIAL (K802362)Dentsply Intl.1980-10-10
AUTOLET (K801815)Ulster Scientific, Inc.1980-10-10
HYCEL TRIGYCERIDE II TEST (K802422)Hycel, Inc.1980-10-06
MINGOGRAF EEG10 (K802296)Siemens Corp.1980-10-03
BEAR 2 ADULT VOL. VENTILATOR (K802118)Bourns Medical Systems, Inc.1980-10-03
CT-1600 DIGITAL PULSE RATE MONITOR (K802204)Industrial & Biomedical Sensors Corp.1980-10-03
PROTECTIVE BAR FOR THE MA-1VENTILATOR (K802270)Eastern Anesthesia, Inc.1980-10-03
PRESSURE GAUGE ACCESSORY KIT/DILATATION (K802261)Stanco Medical, Inc.1980-10-03
EGS #300 BATTERY OPER. PORTA. MUSCLE STI (K802107)Electro-Med Health Industries, Inc.1980-10-03
CM-700A AUTO-INFLATE CONTROL MODULE (K802203)Industrial & Biomedical Sensors Corp.1980-10-03
BABYBIRD 2 VENTILATOR (K802087)Bird Products Corp.1980-10-03
SYSTEM 80 COMPUTERIZED SPIROMETER (K801920)Pulmonary Testing Systems1980-10-03
INFANT VENTILATORY MEASUREMENT SYSTEM (K801497)Medical Graphics Corp.1980-10-03
SYSTEM 88 COMPUTERIZED DIFFUSION ANALY (K801919)Pulmonary Testing Systems1980-10-03
DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID (K800954)The Healthcare Group Laboratories, Inc.1980-10-03
SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO (K801918)Pulmonary Testing Systems1980-10-03
BETA-CAP II (K801679)Quinton, Inc.1980-10-03
SONIA-SO NOGRAPH-NUMERICAL ANALYSIS (K801844)Cgr Medical Corp.1980-10-03
TELEMETRY TRANSMITTER, #TLT-3 (K802273)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-03
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (K800956)The Healthcare Group Laboratories, Inc.1980-10-03
BCM-302 COLLIMATING CONE & COMPENSATIN (K801949)B C Medical , Ltd.1980-10-03
HOT CYCLE, A CHEMICAL TYPE HOT PACK (K802252)Signal West1980-10-03
CABANNA TAN SUNLAMP (K801925)The Marketing Exchange, Inc.1980-10-03
BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO (K801950)B C Medical , Ltd.1980-10-03
U.I. OCTOSON (K802030)Ausonics Pty , Ltd.1980-10-03
ANESTHESIA GAS MACHINE (K802116)Puritan Bennett Corp.1980-10-03
PEDIATRIC OXYGEN OR AEROSOL MASKS, (K802323)Airlife, Inc.1980-10-03
POLYETHYLENE FILLED BONE PLATE (K801603)Zimmer, Inc.1980-10-03
CORROSION PROOF DUAL PURPOSE ECG WIRES (K802237)Custom Cardio Components1980-10-03
MINGOGRAF EEG21 (K802292)Siemens Corp.1980-10-03
NEWBOURNS INFANT VENTILATOR (K802051)Bourns Medical Systems, Inc.1980-10-03
ECG/RESPIRATION STIMULATOR (K802205)Healthdyne, Inc.1980-10-03
OXFORD HUMAN MILK PASTEURISER (K801246)Vickers America Medical Corp.1980-10-03
DISPOSABLE CONSTRAST DELIVERY SPIKE KIT (K802329)Stanco Medical, Inc.1980-10-03
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC (K802281)Sherwood Medical Co.1980-10-03
VESSEL RETRACTOR, #600732 (K802244)Bentley Laboratories, Inc.1980-10-03
SPEMBLY 9000 & 9300 (K802063)Spembly Medical , Ltd.1980-10-03
HESSBURG-BFRRON TREPHINE (K801585)Precision Instruments, Inc.1980-10-03
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Track 1980 automatically

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