Atlas FDA

1984

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

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RecordFirmDate
KODAK T-MAT H FILM SO-118 (K843148)Eastman Kodak Company1984-08-27
BAIM CORONARY SINUS FLOW CALCULATOR (K842831)Electro-Catheter Corp.1984-08-27
TOTAL PROTEIN ASSAY KIT (K843028)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
SYSTEMATE ALBUMIN (K843108)Em Diagnostic Systems, Inc.1984-08-27
MAGNESIUM ASSAY KIT (K843031)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
KODAK T-MAT C FILM SO-119 (K843149)Eastman Kodak Company1984-08-27
ARGYLE CUSTOM TUBING PACK (K842889)Sherwood Medical Co.1984-08-27
HIGH DENSITY LIPOPROTEIN PRECIPITATIN (K843029)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
FOGARTY OCCLUDER PAD (K831809)Thomas J. Fogarty, M.D.1984-08-27
HOOK (K841625)Plastafil, Inc.1984-08-27
DRILL BIT (K841629)Plastafil, Inc.1984-08-27
SYSTEMATE TOTAL PROTEIN 67218 (K843107)Em Diagnostic Systems, Inc.1984-08-27
SERVOCARD SCP-840 (K842312)Litton Datamedix1984-08-27
SYSTEMATE CREATININE 67223 (K843105)Em Diagnostic Systems, Inc.1984-08-27
PUNCH (K841626)Plastafil, Inc.1984-08-27
SYSTEMATE GLUCOSE 67215 (K843151)Em Diagnostic Systems, Inc.1984-08-27
THE DENVER PLEURAL-PERITONEAL SHUNT (K842139)Denver Biomedicals, Inc.1984-08-27
CARDIAC SUPPLY TRAY (K842645)Deroyal Industries, Inc.1984-08-27
SYSTEMATE TRIGLYCERIDE 67219 (K843106)Em Diagnostic Systems, Inc.1984-08-27
INORGANIC PHOSPHORUS ASSAY KIT (K843030)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
PRESSURE MONITOR (K842194)Norton Texas Medical Products1984-08-27
CARDIOTOMY RESERVOIR W/FILTER BCR-3500 (K842620)American Bentley1984-08-27
ANGIOGRAPHIC PROCEDURE TRAY (K840391)Triad Medical Division1984-08-27
MICRO FLUID APPLICATOR (K841357)Treace Medical, Inc.1984-08-24
ESOPHAGEAL STETHOSCOPES (K843070)Primrose Medical, Inc.1984-08-24
BIAS TOTAL HIP (K842906)Zimmer, Inc.1984-08-24
QUALINE WHEELCHAIR PRODUCTS (K843213)Contemporary Health Sys1984-08-24
PICKER ARTIS ULTRASOUND IMAGING SYS (K842055)Philips Medical Systems (Cleveland), Inc.1984-08-24
KERR COMMAND ULTRAFINE POLISHING PASTE (K843022)Kerr Corporation (Danbury)1984-08-24
SURE & NATURAL DEODORANT MAXI-SHIELD (K843155)Johnson & Johnson Professionals, Inc.1984-08-24
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR (K841041)Miles Laboratories, Inc.1984-08-24
ELECTRONIC DIGITAL BP METER HC 3001 (K842486)North American Philips Corp.1984-08-24
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP (K843073)Greene International Corp.1984-08-24
MEGASON MODEL 150 (K843221)Birtcher Corp.1984-08-24
540 CAPNOGRAPH (K842978)Spacelabs, Inc.1984-08-24
CUSTOM STERILE PROCEDURE TRAYS-MULTI (K841850)Sterilco, Inc.1984-08-24
BP-1000 (K843009)Pollenex Associated Mills, Inc.1984-08-24
BP800, 850 1000 (K841095)Associated Mills, Inc.1984-08-24
CPR LOCATOR (K833737)Lifepoint,Inc1984-08-24
DUOCLON COLOR-CEPT (K842314)Organon, Inc.1984-08-24
ACU-DERM TRANSPARENT WOUND DRESSING (K842186)Acme United Corp.1984-08-24
TAMBRANDS INC. ILL.P. 2 (K843061)Tambrands, Inc.1984-08-24
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR (K843071)Primrose Medical, Inc.1984-08-24
INTERMITTENT URETHRAL CATHETER TRAY (K841769)Seamless Hospital Products Co.1984-08-24
RIONET HEARING AID HB-35 (K842875)Rion Acoustic Instruments, Inc.1984-08-24
ACCESSORY FOR ADULT VOL. VENTILATOR (K842580)Infrasonics Corp.1984-08-24
SUPER MAXITHINS BODY-SHAPED MAXI PADS (K842950)Tambrands, Inc.1984-08-23
SERIMM SURE ASO-CHEK CONTROL SERUM (K842839)Analytical Products, Inc.1984-08-23
BETA SCAN DRYSTIX (K841369)Orange Medical Instruments, Inc.1984-08-23
EARETTE HEARING AID OTICON E31V (K842073)Oticon Corp.1984-08-23
EARETTE HEARING AID OTICON E30V (K842074)Oticon Corp.1984-08-23
TX-2 THERMAL DILUTION CARDIAC OUTPUT (K834408)Waters Instruments, Inc.1984-08-23
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO (K843262)Hewlett-Packard Co.1984-08-23
DOPPLER IMAGING OPTION (K840140)Hewlett-Packard Co.1984-08-23
TANDEM FAST VISUAL HCG ASSAY KIT - (K842633)Hybritech, Inc.1984-08-23
BEHING THE EAR HEARING AID T-98 (K842434)Bernafon, Inc.1984-08-23
AUGMENTIN 30 MCG SENSI DISC (K842253)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-23
MAXITHINS BODY-SHAPED PANTY SHIELDS (K842951)Tambrands, Inc.1984-08-23
REGULAR MAXITHINS BODY-SHAPED MAXI (K842952)Tambrands, Inc.1984-08-22
DYNASCOPE SERIES (K840055)Fukuda Denshi USA, Inc.1984-08-22
BETA-HCG HEMAGGLUTINATION TEST (K842181)Sero-Immuno Diagnostics, Inc.1984-08-22
QCA TRIGLYCERIDES (K842891)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-22
ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT (K842752)The Perkin-Elmer Corp.1984-08-22
COMPANION 492 OXYGEN CONCENTRATOR (K843243)Puritan Bennett Corp.1984-08-22
ULTRA SHAPE CONDOMS (K833365)Barnetts, Inc.1984-08-22
NOVA 12 CARDIAC OUTPUT COMPUTER (K840009)Nova Medical Specialties1984-08-22
PRO-SOFT DEHYDRANT (K842863)Anatech, Ltd.1984-08-21
PUCK U & UD CUTFILM CHANGERS (K842911)Elema-Schonander, Inc.1984-08-21
REFRAX MOUNTING MEDIUM (K842986)Anatech, Ltd.1984-08-21
INTERFERENZ 4 (K842803)Robert Bosch Corp.1984-08-21
ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL (K842953)All-Hands Medical Supply, Inc.1984-08-21
ADP NDNA IFA TEST (K842707)Apple Diagnostic Products1984-08-21
SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (K842903)Elema-Schonander, Inc.1984-08-21
PRO-PAR CLEARANT (K842861)Anatech, Ltd.1984-08-21
MICRO DELTA & CELTAPRO (K841964)Computer Design & Applications, Inc.1984-08-21
DIADYN 4 (K842804)Robert Bosch Corp.1984-08-21
NERVE STIMULATOR Q10 (K843175)Acm Systems1984-08-20
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG (K843065)Otisville Biotech, Inc.1984-08-20
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS (K841287)Convatec, A Division of E.R. Squibb & Sons1984-08-20
MINIMUM ESSENTIAL MED W/L-GLUTAMINE (K842776)Sigma Chemical Co.1984-08-20
ASSURE-BREATHABLE PANTY LINERS/SCENT (K841312)Personal Products Co.1984-08-20
BIOTIS CIN AGAR PLATES (K843066)Otisville Biotech, Inc.1984-08-20
ASSURE-BREATHABLE PANTY LINERS/UNSCENT (K841311)Personal Products Co.1984-08-20
AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY (K842542)American Pharmaseal Div. Ahsc1984-08-20
CUSHION-FLEX TM (K843169)Life Design Systems, Inc.1984-08-20
MICROSURGICAL CO2 LASER SYS - 4100 (K840406)Bio Quantum Technologies, Inc.1984-08-20
MEDICAL EMERG. STABILIZER OBJECT/BODY (K842254)Walter Ansted Co.1984-08-20
AMERICAN EDWARDS LABS FLEXISCOPE (K841607)American Edwards Laboratories1984-08-18
RADOVAN TISSUE EXPANDER (K842883)Mentor Corp.1984-08-17
SANDARE ACID PHOSPHATASE PROCEDURE (K842516)Sandare Chemical Co., Inc.1984-08-17
BROWNIE BOOTH BB1 (K842975)Weingart, Inc.1984-08-17
ACTH STANDARD MATRIX (K842099)Diagnostic Systems Laboratories, Inc.1984-08-17
COAT-A-COUNT DHEA-SO4 RIA KIT (K842552)Diagnostic Products Corp.1984-08-17
AIMED DISPOS. INJECTION NEEDLE (K842230)Tech-Cons Ltd., Intl.1984-08-17
HYCEL ROTOR-MIXER AND/OR MULTI (K842746)R&D Systems, Inc.1984-08-17
BLOM-SINGER LOW PRESSURE VOICE PROSTHES (K842896)American V. Mueller1984-08-17
SAFRANIN STAIN (K842734)E K Ind., Inc.1984-08-17
AVA-NEB NEBULIZER (K843102)Avatron, Inc.1984-08-17
MICROPOROUS MED. ADHESIVE TAPE (K840447)Lectec Corp.1984-08-17
HOWMEDICA KINEMATIC II TIBIAL WEDGE (K842367)Howmedica Corp.1984-08-17
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Track 1984 automatically

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