Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (K851220)Northern Electric Co. Div. of Sunbeam Corp.1985-09-17
BARD-PARKER OCCLUSION BALLOON CATHETER (K852294)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-17
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 (K853223)Telectronics, Inc.1985-09-17
PROXIMAL POROCOAT MODIFIED MEDICAL ASPECT AML HIP (K853205)Depuy, Inc.1985-09-16
PRECEPT CEFOPERAZONE (K853596)Austin Biological Laboratories1985-09-16
SAF-D-FIB (K852469)Medtronic Andover Medical, Inc.1985-09-16
HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE (K852797)Mansfield Scientific, Inc.1985-09-16
CARBOCONE (K851732)Imtech Corp.1985-09-16
ENZYGNOST + ANTI-CMV IGG TEST (K852478)Behring Diagnostics, Inc.1985-09-16
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 (K852972)Telectronics, Inc.1985-09-16
MODERN MEDICAL PRODUCTS TOWEL CLAMP (K853583)Modern Medical Products1985-09-16
CMV-IHA (K852494)Hillcrest Biologicals1985-09-16
GILFORD IMMUNOGLOBULIN G REAGENT (K853465)Gilford1985-09-16
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD (K852513)C.R. Bard, Inc.1985-09-16
GILFORD IMMUNOGLOBULIN A REAGENT (K853467)Gilford1985-09-16
SURGICAL ASPIRATOR (K850946)Medicalex1985-09-16
TDX REA BUN (K853677)Abbott Laboratories1985-09-16
ALCOHOL CALIBRATORS (K853532)Diagnostic Systems1985-09-16
PRECEPT CEFTRIAXONE (K853273)Austin Biological Laboratories1985-09-16
GILFORD IMMUNOGLOBULIN M REAGENT (K853469)Gilford1985-09-16
APL SIMMONS CITRATE AGAR (K853617)Apl Medical Supplies1985-09-16
APL SIM MEDIUM (K853618)Apl Medical Supplies1985-09-16
HEMATOCRIT-SATURATION MONITOR HSM-100 (K852124)American Bentley1985-09-16
2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR) (K852799)Cardiac Recorders, Ltd.1985-09-16
PRECEPT TM CARBENICILLIN (K853685)Austin Biological Laboratories1985-09-16
FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM (K851450)Flow Cytometry Standards Corp.1985-09-16
GILFORD C3 COMPLEMENT REAGENT (K853466)Gilford1985-09-16
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) (K853127)Micromedic Systems1985-09-16
APL MOTILITY INDOLE ORNITHINE AGAR (K853610)Apl Medical Supplies1985-09-16
MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP (K853601)Bowen & Company, Inc.1985-09-16
STERILIZATION CONTAINER (K852335)Bemis Mfg. Co.1985-09-16
CORNING CELL WELLS-MULTIPLE WELL PLATES (K853634)Corning Medical & Scientific1985-09-16
APL TRIPLE SUGAR IRON AGAR (K853619)Apl Medical Supplies1985-09-16
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 (K852455)Gambro, Inc.1985-09-16
PRECEPT METHICILLIN (K853772)Austin Biological Laboratories1985-09-16
CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) (K852808)Cardiac Recorders, Ltd.1985-09-16
ACCU-FLO PRESSURE VALVE (K853215)Codman & Shurtleff, Inc.1985-09-16
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA (K851913)Cordis Corp.1985-09-16
REFLOTRON SYSTEM (K852133)Boehringer Mannheim Corp.1985-09-16
MAGNESIUM (K853592)Pointe Scientific, Inc.,1985-09-16
ABSORBANCE TEST SOLUTION (K853533)Diagnostic Systems1985-09-16
DIASCAN CONTROL (K853553)Home Diagnostics, Inc.1985-09-16
QCA ENZYMATIC GLUCOSE (K853656)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-16
GILFORD C4 COMPLEMENT REAGENT (K853468)Gilford1985-09-16
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I (K853547)American Dade1985-09-16
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST (K852779)Syva Co.1985-09-16
TEMPORARY PACEMAKER GROUND WIRE (K852119)Scholten Surgical Instruments, Inc.1985-09-15
CHALLENGER SUNRISE (K853248)Challenge Products, Inc.1985-09-13
PRECEPT TM MOXALACTAM (K853689)Austin Biological Laboratories1985-09-13
NEOS - M ABP (K853058)Biotronik Sales, Inc.1985-09-13
PRECEPT TM MEZLOCILLIN (K850833)Austin Biological Laboratories1985-09-13
OPHTHASCAN B (K844686)Biophysic Medical, Inc.1985-09-13
PRECEPT TM AMIKACIN (K853686)Austin Biological Laboratories1985-09-13
PRECEPT KANAMYCIN (K853684)Austin Biological Laboratories1985-09-13
PRECEPT NETILMICIN 32-13 (K853687)Austin Biological Laboratories1985-09-13
600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L (K853394)Interlab(Electromechanical)1985-09-13
PRECEPT TM TOBRAMYCIN (K853688)Austin Biological Laboratories1985-09-13
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (K853486)Olympus Corp.1985-09-12
APL TRYPTIC SOY BROTH (K853609)Apl Medical Supplies1985-09-12
SKYTRON ELITE 6000 & 6001 SURGICAL TABLES (K853480)Skytron, Div. the Kmw Group, Inc.1985-09-12
EXTERNAL PACEMAKER TELECTRONICS TE200 (K852746)Seamed Corp.1985-09-12
MINIFILTER HEMOFILTER (K853510)Amicon, Inc.1985-09-12
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW (K853206)Telectronics, Inc.1985-09-12
TRIOS - M (K853057)Biotronik Sales, Inc.1985-09-12
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE (K853207)American Pharmaseal Div. Ahsc1985-09-12
NORELCO ELECTRONIC DIGITAL BP METER HC3501 (K852128)Philips Park1985-09-12
ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (K853312)Argon Medical Corp.1985-09-12
MODEL 78560A CENTRAL STATION PATIENT INFO SYS (K852514)Hewlett-Packard Co.1985-09-12
CANNULA CLAMP (K853538)Cp Medical1985-09-12
APL XYLOSE LYSINE DEOXYCHOLATE AGAR (K853611)Apl Medical Supplies1985-09-12
ORTHO DNA PROBE HSV CONFIRMATION TEST (K852360)Ortho Diagnostic Systems, Inc.1985-09-12
VELCRO TOURNIQUET (K853537)Cp Medical1985-09-12
SPR 2 AUTODILUTER (K853380)Scientific Sales Intl., Inc.1985-09-12
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO (K851242)Cook, Inc.1985-09-11
H-H FIXATION & JOINING CONNECTORS (K853369)Holter-Hausner Intl.1985-09-11
ACUFEX COMPARATIVE SURGICAL KERATOMETER (K852424)Acufex Microsurgical, Inc.1985-09-11
SIMPLEX ENHANCEMENT MIXER (K853310)Howmedica Corp.1985-09-11
STERILE BIOPSY NEEDLES (K853559)Plasmedics, Inc.1985-09-11
VSM-5 (K852322)Physio-Control Corp.1985-09-11
H-H BURR HOLE CATHETER SUPPORT (K853367)Holter-Hausner Intl.1985-09-11
TRAUMA TABLE (K853535)Xre Corp.1985-09-11
DIALYZER, CAPILLARY, HOLLOW FIBER (K853591)Organon Teknika Corp.1985-09-11
VISITEC IRRIGATION CONTROL SYSTEM (K853243)Visitec Co.1985-09-11
H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT (K853366)Holter-Hausner Intl.1985-09-11
BEAR NICU-1 (K853346)Bear Medical Systems, Inc.1985-09-11
RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT (K852749)Mesa Medical, Inc.1985-09-10
MEDIPART LUNG AEROSOL KIT MP-1012A (K851198)Medipart Jerry Alexander1985-09-10
MEDIPART LUNG AEROSOL KIT MP-1012A-M (K851199)Medipart Jerry Alexander1985-09-10
MEDIPART LUNG AEROSOL KIT MP-1024A (K851200)Medipart Jerry Alexander1985-09-10
MARLIN SOFT LENS HANDLER (K850984)Marlin Industries1985-09-10
LIFE LINC PATIENT CABLE (K853452)Tronomed, Inc.1985-09-10
MARLIN SOFT LENS TWEEZER (K850983)Marlin Industries1985-09-10
MEDIPART LUND AEROSOL KIT MP-1024A-M (K851201)Medipart Jerry Alexander1985-09-10
BENTLEY-TRANTEC DISPOS. DOMES D-260- (K841811)American Bentley1985-09-09
REMOTE CONTROL MODULE (K851643)Circadian, Inc.1985-09-09
COPAL DIGITAL SPHYGMOMANOMETER UA-560 (K851223)Takeda Medical, Inc.1985-09-09
#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD (K852953)Design Med. Corp.1985-09-06
APL BILE ESCULIN/AZIDE AGAR (K853615)Apl Medical Supplies1985-09-06
APL GN BROTH (K853613)Apl Medical Supplies1985-09-06
REUSABLE DEXTRA SYNOVIAL RESECTORS IN 3.5/4.5/5.5M (K853491)Chattanooga Group, Inc.1985-09-06
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Track 1985 automatically

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