Atlas FDA

1981

3,287 FDA 510(k) clearances · Clearance year

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RecordFirmDate
P51 ANGIOPLASTY PRESSURE TRANSDUCER (K813331)Konigsberg Instruments, Inc.1981-12-29
VITALOG PMS-8 MONITOR (K812739)Vitalog Corp.1981-12-29
MICRO-PREPROCESSOR UNIT (K812914)General Electric Co.1981-12-29
CARDIOINTEGRAM (K812971)Ocg Technology, Inc.1981-12-29
TISSUE PROCESSING CASSETTES & ACCESS (K813430)American Optical Corp.1981-12-29
DIGITAL FLUROGRAPHIC IMAGING SYSTEM (K813217)Diasonics, Inc.1981-12-29
METRONIDAZOLE 80MCG. SENSI-DISC (K813387)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-12-29
CONVERTORS STERILE DISP. LAP SPONGE II (K813296)American Convertors Div., American Pharmaseal1981-12-29
VENOUS CANNULA TRAY (K813284)Cunningham Woodland, Inc.1981-12-29
TEMPERATURE PROBES (K813271)Webster Laboratories, Inc.1981-12-29
AMMONIA TEST (K813366)Wako Pure Chemical Industries, Ltd.1981-12-22
GRAM STAIN REAGENTS AND KIT (K813369)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-12-22
PROGESTERONE KIT BY RIA (K813484)Immuchem Corp.1981-12-22
RADIOIMMUNOASSAY FOR HUMAN THYROID (K813392)Leeco Diagnostics, Inc.1981-12-22
SHARIA-LH RIA KIT FOR QUANTITATION HORMO (K813213)Intl. Immunoassay Laboratories, Inc.1981-12-22
ELECTROLYTE GEL (K813370)Hi Chem, Inc.1981-12-22
MULTIWASH (K813426)Flow Laboratories, Inc.1981-12-22
VYGON ENDOTRACHEAL TUBES (K813373)Exco, Inc.1981-12-22
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL (K813349)Stanbio Laboratory1981-12-22
COAT-A-COUNT TESTOSTERONE RIA KIT (K813401)Diagnostic Products Corp.1981-12-22
AGGLUTEX METHAQUALONE TEST KIT (K812987)Hoffmann-La Roche, Inc.1981-12-22
TRIGLYCERIDE CALIBRATORS (K813478)Gilford Diagnostics1981-12-22
CPK(CK) IN VITRO DIAG. REAGENT SET (K813406)Pointe Scientific, Inc.,1981-12-22
TROCKI BODY VENTRILATOR (K813326)L.T.D. 3 Co.1981-12-22
AST(SGOT) IN VITRO DIAG. REAGENT SET (K813405)Pointe Scientific, Inc.,1981-12-22
INORGANIC PHOSPHORUS REAGENT SET (K813400)Anco Medical Reagents & Assoc.1981-12-22
TOBRAMYCIN REAGENT TEST KIT (K813391)Beckman Instruments, Inc.1981-12-18
THERMOMETER SHEATHS (K813423)Abco Dealers, Inc.1981-12-18
OXYGEN CONNECTING TUBE (K813197)Northern Medical Industries1981-12-18
PHILLY BOLT (K813440)Philadelphia Medical Specialties1981-12-18
NON-ADHER PADS (K813421)Abco Dealers, Inc.1981-12-18
FLAT DRAIN (K813063)Sil-Med Corp.1981-12-18
DOCUMENT LINEARITY TEST STANDARDS (K813411)North American Standards1981-12-18
CONTURA DISPOS. SURG. FACE MASK (K813078)American Convertors Div., American Pharmaseal1981-12-18
LAZARUS-NELSON PERITONEAL LAVAGE TRAY (K813336)American Pharmaseal Div. Ahsc1981-12-18
BOUNDARY DRAPE TAPE (K813277)The Buckeye Cellulose Corp.1981-12-18
WOUND-EVAC (K813341)Heritage Medical Products1981-12-18
BAXA ADLI SEAL (K813435)Baxa Corp., Sub. of Cook Group, Inc.1981-12-18
MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER (K813409)Yellow Springs Instrument Co., Inc.1981-12-18
THERMOMETERS (K813424)Abco Dealers, Inc.1981-12-18
VPI URETERAL DILATATION BALLON CATHETER (K813278)Vance Products, Inc.1981-12-18
DIRECT FA CONJUGATE FOR LEGIONELLA SP (K813339)Springwood Microbiologicals1981-12-18
MINI-SHAKER (K813318)Dynatech Corp.1981-12-17
NEIA TRANSFERRIN ENZYMEIMMUNOASSAY (K813288)New England Immunology Assoc.1981-12-17
RIAGEN PAP RIA (K813261)Biogenex Laboratories1981-12-17
ANDRIA-FSH RIA TEST KIT (K813086)Intl. Immunoassay Laboratories, Inc.1981-12-17
QAC CONTROL (K812950)The Quality Assurance Service Corp.1981-12-17
A-1 IN-HOME PREGNANCY TEST (K813272)C.F. Medical, Inc.1981-12-17
A-1 TEST (K812788)C.F. Medical, Inc.1981-12-17
ORTHO CO2 DILUENT LEVEL I (K813293)Ortho Diagnostic Systems, Inc.1981-12-17
MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK (K812994)General Diagnostics1981-12-17
ASTRA REAGENT CONCENTRATE SYSTEM (K812866)Nobel Scientific Industries, Inc.1981-12-17
ACU-SLIDE TEST (K812789)C.F. Medical, Inc.1981-12-17
ORTHO* UNASSAYED CONTROL SERUM LEVEL I (K813321)Ortho Diagnostic Systems, Inc.1981-12-17
MS-2 BACTERIAL IDENTIFICATION SYS (K813031)Abbott Laboratories1981-12-17
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN (K812298)Syn-Kit, Inc.1981-12-17
ORTHO CO2 DILUENT LEVEL II (K813294)Ortho Diagnostic Systems, Inc.1981-12-17
SECURE FDI TEST KIT (K813216)Beckman Instruments, Inc.1981-12-17
RA-80 POSITIVE CONTROL (K813309)Sun-Kit1981-12-17
ORTHO CO2 DILUENT LEVEL III (K813295)Ortho Diagnostic Systems, Inc.1981-12-17
NO-HOIL COMBOSTAT II KIT (K813310)Ria Products, Inc.1981-12-17
CARAFLEX ELASTIC POLYMER PLASTER BANDA (K813219)Carapace, Inc.1981-12-17
ABURIA-CK RIA TEST KIT (K813087)Intl. Immunoassay Laboratories, Inc.1981-12-17
PCS-5 ACCESSORIES (K812766)Timeter Instrument Corp.1981-12-17
ORTHO* UNASSAYED CONTROL SERUM LEVEL III (K813322)Ortho Diagnostic Systems, Inc.1981-12-17
VRT TABLE W/INTEGRATING TUBE STAND/ELEV (K813173)General Electric Co.1981-12-14
BLOOD PRESSURE MONITOR (K812936)Amertek1981-12-14
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36 (K813021)Brentwood Instruments, Inc.1981-12-14
ULTRA-WIDE SAFETY SPECTACLE FRAME (K813156)Zee Medical Products Co., Inc.1981-12-14
CC-201 ECG MONITORING SYSTEMS (K813287)Anthro-Metrics Corp.1981-12-14
FECAL INCONTINENCE COLLATOR (K813270)Hollister, Inc.1981-12-14
RADIATION STERILIZATION FOR NEEDLE CNTR (K812444)Devon Industries, Inc.1981-12-14
ASPIRATOR VENTURI SYSTEM MODEL 55-JV (K813319)J. H. Emerson Co.1981-12-14
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2 (K813009)Teca, Inc.1981-12-14
DISPOSABLE DIAPHRAGM DOMES (K813267)Dio-Med Corp.1981-12-14
TOURNIQUET (K813231)Aspen Laboratories, Inc.1981-12-14
BOMED-NCCOM (K813020)Bomed Medical Mfr., Ltd.1981-12-14
VALVED SURGICAL ASPIRATORS (K813029)Imedix1981-12-14
BRISTOL BALLON INTRODUCER, MANDRIL SET (K813332)Inmed Corp.1981-12-14
DESERET NEOLON SURGICAL GLOVES (K813088)Warner-Lambert Co.1981-12-14
INTERAD WHOLE BODY CT SCANNER (K813162)Interad Systems, Inc.1981-12-14
VASCULAR PAWS (K813062)Sil-Med Corp.1981-12-14
UNSCENTED MENSTRUAL PADS-MINI PADS (K813252)I.C.D. Industries, Inc.1981-12-14
PRESSURE INFUSION PUMP (K813105)Calbio, Inc.1981-12-14
SYNEVAC VACUUM CURETTAGE SYSTEMS (K813282)Synemed, Inc.1981-12-14
UNSCENTED MENSTRUAL PADS-MAXI PADS (K813251)I.C.D. Industries, Inc.1981-12-14
TERUMO HOLLOW OXYGENATOR CIRCUIT (K812659)Terumo Medical Corp.1981-12-14
MICRO TRANSDUCER CATHETERS (K813125)Honeywell, Inc.1981-12-14
KODAK INTENSIFYING SCREEN 80-175 (K813147)Eastman Kodak Company1981-12-14
TERUMO HOLLOW FIBER OXYGENATOR (K812660)Terumo Medical Corp.1981-12-14
HYGIENTIST; CYCLOSON I & II; RETROFIT (K812909)Fibra Sonics, Inc.1981-12-14
FLOWGUARD CATHETERS & CANNALAE (K813037)Advocacy International, Ltd.1981-12-14
ELECTROCARDIOGRAPH CM3000 (K813279)Philips Medical Systems (Cleveland), Inc.1981-12-14
IONESCU-SHILEY VALVE HOLDER & HANDLE (K813276)Shiley, Inc.1981-12-10
EPCOM EMS-180 ANTEPARTUM FETAL MONITOR (K813007)Epcom Medical Systems, Inc.1981-12-10
BIPOLAR OPTIMA MP #255 (K813079)Telectronics, Inc.1981-12-10
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP (K813134)Telectronics, Inc.1981-12-10
CONPHAR, TUNING FORKS (K813304)Conphar, Inc.1981-12-10
SIEMENS-ELEMA PULSE GENERATOR 668 B (K812610)Siemens Corp.1981-12-10
ETHICON* TEMP. CARDIAC PACING WIRE (K813138)ETHICON, Inc.1981-12-10
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Every clearance here is in the API, with alerts when new ones post.