Atlas FDA

1984

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

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RecordFirmDate
EEG-4300 W/OPTINAL ACCESS. EEG 4314 & (K842714)Nihon Kohden America, Inc.1984-09-25
CRYSTAL MEDICAL MILK COLLECTION KIT (K842766)Crystal Medical Products, Inc.1984-09-25
LORRAINE DSL LABOR & DELIVERY BED (K842962)Pulley-Kellam Co., Inc.1984-09-25
PERRY DERMAGUARD SURGICAL GLOVES (K843125)Perry, Div.1984-09-25
LIFELINE TLE 476-04 (K843393)Intermedics, Inc.1984-09-24
ELECTRODE PACEMAKER, PERM & TEMP (K840668)Vitatron Medical BV1984-09-24
LIFELINE TLE 484-02 (K843394)Intermedics, Inc.1984-09-24
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR (K842364)Cardiac Pacemakers, Inc.1984-09-24
VENI-SHIELD (K842999)U.S. Mfg. & Management, Inc.1984-09-24
PHARMA-PLAST SMOOTH BORE CONNECTORS (K843476)Zimmar Consulting , Ltd.1984-09-24
PHARMA-PLAST PETRI DISH (K843483)Zimmar Consulting , Ltd.1984-09-21
WRINKLE CHAPEAU BLACKY (K842502)Circle Rubber Corp.1984-09-21
PRECISION DISPENSER (K843606)Medical Technomics, Ltd.1984-09-21
ANGIO SYS FLUOROSCOPE DRAPE (K843259)Angiosystems, Inc.1984-09-21
STANBIO QUICK-TELL MONOCLONAL INDIRECT (K842544)Stanbio Laboratory1984-09-21
MINICAPS (K843361)Medical Technomics, Ltd.1984-09-21
LABOPETTOR (K843607)Medical Technomics, Ltd.1984-09-21
ANGIO SYS BRACHIAL ANGIO DRAPE (K843258)Angiosystems, Inc.1984-09-21
ACE/FISHER EXTERNAL FIXATOR (K842768)Buckman Co., Inc.1984-09-21
DRABKIN REAGENT (K842931)E K Ind., Inc.1984-09-21
12SSL-SC (K842308)Marquette Electronics, Inc.1984-09-21
RINGCAPS (K843362)Medical Technomics, Ltd.1984-09-21
ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE (K843260)Angiosystems, Inc.1984-09-21
AXCAN UTERINE SUCCION INJECTOR (K842943)Axcan Scientific Corp.1984-09-21
ANGIO SYS STERILE FIELD COVER (K843257)Angiosystems, Inc.1984-09-21
IVAC C80014 Y SOLUTION ADMIN. SET (K843185)Y1984-09-20
ACID PHOSPHATASE ASSAY KIT (K843380)Diagnostic Chemicals, Ltd. (Usa)1984-09-20
RAICHEM CALCIUM REAGENT (K843353)Reagents Applications, Inc.1984-09-20
FRONT RADIUS CUTTER (K841620)Plastafil, Inc.1984-09-20
BACK RADIUS CUTTER (K841621)Plastafil, Inc.1984-09-20
GENERAL SURGERY TRAY (K842648)Deroyal Industries, Inc.1984-09-20
AMIZYME-ANA TEST KIT (K842532)Amico Lab, Inc.1984-09-20
SENTRA (K843060)Cardiac Pacemakers, Inc.1984-09-20
ECLIPSE HEART SUPPORT FOR CORONARY ARTER (K843216)Biotrac Laboratories1984-09-20
CUSTOM NEURO TRAY (K842625)Deroyal Industries, Inc.1984-09-20
SERVOMED OXCARDIORE SPIROGRAPH 324/111 (K840832)Litton Medical Electronics1984-09-20
SANG-A PETROLATUM GAUZE USP STERILE (K843035)Tech-Cons Ltd., Intl.1984-09-20
SYSTEMATE GOT 67208 (K843333)Em Diagnostic Systems, Inc.1984-09-20
ARROW-JOHANS ECG ADAPTOR (K843263)Arrow Intl., Inc.1984-09-20
SERVOMED MEDIVISION SCOPE SMV-235 (K840209)Litton Medical Electronics1984-09-20
AUSTIN ENDOLYMPH DISPERSMENT SHUNT (K834094)Treace Medical, Inc.1984-09-20
SYSTEMATE D-BILI 67213 (K843329)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE T-BILI 67212 (K843328)Em Diagnostic Systems, Inc.1984-09-20
NU-THOR THORACOSTOMY KIT (K842666)Intl. Medical Devices , Ltd.1984-09-20
SELF-ALIGNING ACETABULAR COMPONENT (K831792)Endomedics, Inc.1984-09-20
AMIZYME-ANDNA TEST KIT (K842533)Amico Lab, Inc.1984-09-20
SYSTEMATE GPT 67209 (K843334)Em Diagnostic Systems, Inc.1984-09-20
EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT (K843458)Syva Co.1984-09-20
WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP (K843188)Wells Johnson Co.1984-09-20
MEDILASER-S MEL-444-S (K840739)Mochida Pharmaceutical Co., Ltd.1984-09-20
UNILET LANCET (K842517)Ulster Scientific, Inc.1984-09-20
LOW PRESSURE ALARM FOR OXYGEN CYLINDER (K843212)Hospitak, Inc.1984-09-19
ELECTROSTIM 380 (K843488)Micron Instruments, Inc.1984-09-19
AUTOMATIC PATIENT CHAIR PM2000 & A (K842359)Planmeca USA, Inc.1984-09-19
TRACHEAL TUBE 16 GAUGE-1.65MM- (K832466)Erie Medical1984-09-19
MEDCOLATOR MODEL GX (K842712)Medco Products, Co., Inc.1984-09-19
OB ULTRASOUND LINEAR SCANNER 630 (K842261)Ge Medical Systems Information Technologies1984-09-19
SONIC AID GREEN ULTRASOUND GEL (K843167)Wpc Brands, Inc.1984-09-19
TOP DISPOSABLE SPINAL NEEDLE (K843313)Top Surgical Manufacturers Co.1984-09-19
ACKRAD HYSTEROSALPINGOGRAPHY SET (K842231)Ackrad Laboratories1984-09-19
DISPOSABLE TISSUE EFFECT BIOSENSOR-T (K843157)Pan Dynamics Medical Corp.1984-09-19
BARD CO2 SURGICAL LASER SYS SLS-50/100 (K834166)C.R. Bard, Inc.1984-09-18
OMNISOUND THERAPY UNIT (K843372)Physio Technology, Inc.1984-09-18
OMNISTIM II COMBIN. THERAPY SYS (K843351)Physio Technology, Inc.1984-09-18
INFUSE-A-PORT HEPARIN LOCK MAINT KIT (K840481)Infusaid Corp.1984-09-18
RICHARDS INTRA-ARTICULAR SHAVER MOTOR (K842475)Richards Medical Co., Inc.1984-09-17
STRATUS CORTISOL FLUOROMETRIC ENZYME (K843183)American Dade1984-09-17
BARD-PARKER FLAT/ROUND SILICONE DRAIN (K843006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-17
ULTRASYSTEM LINSCAN PROBE (K842811)Kelley Development Corp.1984-09-17
AUTOFLUOR IV SYSTEM (K843181)Tech America Diagnostics1984-09-17
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN (K842374)Novametrix Medical Systems, Inc.1984-09-17
FIAX 100 FLUOROMETER (K843356)Intl. Diagnostic Technology1984-09-17
DISPOSABLE LINEAR CUTTER (K843034)ETHICON, Inc.1984-09-17
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT (K843174)Beckman Instruments, Inc.1984-09-14
CORITSOL PREMIX RIA KIT (K842957)Biotecx Laboratories, Inc.1984-09-14
T.I.M.E. DISPENSER (K843272)Dynatech Laboratories, Inc.1984-09-14
CORNING HIGH RESOLUTION PROTEIN ELECTRO (K843397)Corning Medical & Scientific1984-09-14
PROLACTIN IRMA (K842478)Euro-Diagnostics BV1984-09-14
SYSTEMATE CHOLESTEROL 67222 (K843327)Em Diagnostic Systems, Inc.1984-09-14
STREP SELECTIVE II (K843193)Remel Co.1984-09-14
DYNA-LYTE 2000 (K842786)Abbott Diagnostics1984-09-14
ACETIC ACID 1% V/V (K842938)E K Ind., Inc.1984-09-14
ALKALINE PHOSPHATASE REAGENT SET (K843332)Sterling Biochemical, Inc.1984-09-14
SYSTEMATE BUN HEM NO. 67221 (K843326)Em Diagnostic Systems, Inc.1984-09-14
TECHNICON RA-1000 SYS IRON FOR SERUM (K843255)Technicon Instruments Corp.1984-09-14
AMIKACIN CALIBRATOR ACA (K843210)E.I. Dupont DE Nemours & Co., Inc.1984-09-14
ROTALEX LATEX AGGLUTINATION TEST (K841319)Orion Diagnostica, Inc.1984-09-14
MACBETH COLOR EIAD 100/100PC (K842770)Macbeth1984-09-14
ETHYL ALCOHOL ASSAY KIT (K843378)Diagnostic Chemicals, Ltd. (Usa)1984-09-14
INORGANIC PHOSPHORUS TEST (K843177)Sclavo, Inc.1984-09-14
V AGAR SELECTIVE DEEPS (K843194)Remel Co.1984-09-14
EMIT 700 BARBITURATE ASSAY (K843418)Syva Co.1984-09-14
EMIT 700 OPIATE ASSAY (K843162)Syva Co.1984-09-14
ANSWER ONE-DAY (K843238)Armkel, LLC1984-09-14
SYSTEMATE PHOSPHORUS 67217 (K843330)Em Diagnostic Systems, Inc.1984-09-14
MICROBIOLOGICAL TRAY READER-MANUAL (K842947)American Micro Scan1984-09-14
GRAM STAIN SET W/STABILIZED IODINE (K843429)Accra Laboratories, Inc.1984-09-14
NMS 1043 ENZYME IMMUNOASSAY KIT (K842499)Nms Pharmaceuticals, Inc.1984-09-14
LIGHT BEAM COLLIMATOR (K843244)Dealers X-Ray Co., Inc.1984-09-14
ID ZONE NORMAL LD ISOENZYME CONTROL (K843266)Beckman Instruments, Inc.1984-09-13
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Track 1984 automatically

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