Atlas FDA

1981

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

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RecordFirmDate
MILLER/NADLER GLARE TESTER (K812706)Mosebach Electric & Supply1981-11-16
LANCER COAGENT HUMAN FACTOR 1X PLASMA (K812974)Sherwood Medical Co.1981-11-16
INTRODUCER, PERCUTANEOUS SELDINGER (K812964)Triad Medical Division1981-11-16
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD (K812990)Intermedics, Inc.1981-11-16
ENDODONTIC PAPER POINTS (K812886)United Dental Mfg., Inc.1981-11-16
SKI 5000 (K812646)Smithkline Diagnostics, Inc.1981-11-16
ULTRA COM (K812209)Ultranamics, Inc.1981-11-16
PERCUTANEOUS INTRODUCER COURNAND STYLE (K812973)Dip, Inc.1981-11-16
EAST VENTILARM PRESSURE MONITOR ALARM S. (K812960)Cairco , Ltd.1981-11-16
DATASCRIBE #DS-40 (K812765)Timeter Instrument Corp.1981-11-16
DIGICLOT 2-#820 (K812121)Volu Sol Medical Industries1981-11-16
SURGICAL SUCTION INSTRUMENTS-DISPOS. (K812845)Abco Dealers, Inc.1981-11-16
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD (K812989)Intermedics, Inc.1981-11-16
PERITONEAL DIALYSIS CYCLER SET (K813069)American Medical Products, Inc.1981-11-16
VENOFIX SCALP VEIN SET (K813083)Burron Medical Products, Inc.1981-11-16
RESPIRATORY CARE MONITOR (K812977)Advanced Medical Equipment, Inc.1981-11-16
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. (K812944)Millar Instruments, Inc.1981-11-16
DISPOSABLE SUTURE REMOVAL SCISSORS (K812555)Medcare Products1981-11-16
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD (K812725)Medtronic Vascular1981-11-16
TECHNICON RA 1000 SYSTEM (K813077)Technicon Corp.1981-11-16
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD (K812991)Intermedics, Inc.1981-11-16
VANCE-AMBROSE RESECTOSCOPE FORCEPS (K812785)Vance Products, Inc.1981-11-16
EXTRASENSR ULTRAFILTRATION MONITOR (K811972)Extracorporeal Medical Specialities, Inc.1981-11-16
LEECO TESTO-QUANT DIAG. KIT (K813059)Leeco Diagnostics, Inc.1981-11-16
MODEL 900S INTRAOCULAR PROBE (K812219)Lumenis, Inc.1981-11-16
PHOSPHOTUNGSTATE REDUCTION, URIC ACID (K813076)American Monitor Corp.1981-11-16
ORBIC* SPHERICAL ALLOY (K812827)Johnson & Johnson Professionals, Inc.1981-11-16
FETAL VITABILITY TM MODE (K812743)Technicare Corp.1981-11-16
ARGYLE YANKAUER SUCTION TUBE (K813066)Sherwood Medical Co.1981-11-16
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH (K812111)Bionomy, Inc.1981-11-16
VTS-1000 VISUAL TESTING SYSTEM (K812331)Nicolet Biomedical Instruments1981-11-16
SURGICAL LOOPS (K812389)Berkeley Medevices1981-11-16
SURGICAL PAWS (K812388)Berkeley Medevices1981-11-16
BOUNDARY PROCESS CHANGE (K812738)The Buckeye Cellulose Corp.1981-11-16
PDS* ABSORBABLE LIGATING CLIPS (K812323)ETHICON, Inc.1981-11-16
RIND AIRWAY (K812822)Rind Medical Development1981-11-16
MODEL 535-03 TRACE A PACE (K812755)Intermedics, Inc.1981-11-16
PERCUTANEOUS INTRODUCER: SELDINGER STYLE (K813019)Dip, Inc.1981-11-16
SILICONE IMPLANTS (K812691)Sutter Biomedical, Inc.1981-11-16
PET POLYETHYLENE TORQUE CATHETER (K812999)Universal Medical Instrument Corp.1981-11-16
STERILE WATER 4OZ. (K812312)Superior Plastic Products Corp.1981-11-13
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK (K812993)General Diagnostics1981-11-10
ULTRACHEM CA, ITEM #64975 (K813040)Harleco1981-11-10
MULTI CLOT-#819 (K812122)Volu Sol Medical Industries1981-11-10
ULTRACHEM ALB, ITEM #64970 (K813044)Harleco1981-11-10
NEUTRAL DUFFERED FORMA-SCENT (K812817)Meridian Diagnostics, Inc.1981-11-10
UNIVERSAL SUTURE PASSER (K812566)Ortho Pared Instruments, Inc.1981-11-10
RELIEF (K812567)American Pharmaceutical Co., Inc.1981-11-10
KT-1000 DEVICE (K812806)Medmetric Corp.1981-11-10
ULTRACHEM E-CHOL, ITEM #65025 (K813039)Harleco1981-11-10
LORENZ BLOOD GAS ANALYZER (K812090)Lorenz Instruments1981-11-10
E2508 DISPOSABLE HANDSWITCHING PENCIL (K813071)Valleylab, Inc.1981-11-10
PRE-FILLED SYRINGE & CYSTOFLO URINARY BG (K811924)Travenol Laboratories, S.A.1981-11-10
ULTRACHEM TP, ITEM #64974 (K813038)Harleco1981-11-10
LINUS (K812398)Fischer Imaging Corp.1981-11-10
ULTRACHEM CREA ITEM #64972 (K813043)Harleco1981-11-10
BACTEC RESIN CULTURE MED. 16A (K812315)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-11-10
CHANG MEDIUM (K812820)Hana Biologics, Inc.1981-11-10
ULTRAZYME-GT, ITEM #64959 & 65032 (K813041)Harleco1981-11-10
STANDING FRAME (K813025)Barnett Medical1981-11-10
IMMUNO-CELL IMMUNO-SEP KIT (K812411)Kallestad Laboratories, Inc.1981-11-10
ACUPRESS VIBRATOR (K812902)Eicona Corp.1981-11-10
PROTECT-O-SEAL (K813014)Tri-Med, Inc.1981-11-10
SYRINGE, PISTON (K812888)Frisco Products, Inc.1981-11-10
QUANTUMATIC DUAL-WAVELENGTH SPECTRO (K812865)Abbott Laboratories1981-11-10
DSD (K812983)Pm America, Inc.1981-11-10
ULTRACHEM GLUC-DH SET, ITEM #65048 (K813042)Harleco1981-11-10
E2502 & E2502B LECTROSWITCH (K813072)Valleylab, Inc.1981-11-10
LANCER SPECIMEN CONTAINER (K812933)Sherwood Medical Co.1981-11-06
STERILE ADHERENT DRAPES (K812809)Abco Dealers, Inc.1981-11-06
HEALTH-UP (K812432)Wfx Industries, Inc.1981-11-06
CHEMICAL INDICATORS (K812856)Sterilization Technical Services, Inc.1981-11-06
BEHIND-THE-EAR MODEL 115 (K812937)Danavox, Inc.1981-11-06
ARTERIOGRAM TRAY (K812927)American Pharmaseal Div. Ahsc1981-11-06
FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) (K812981)Venusa , Ltd.1981-11-06
VDRL CARBON ANTIGEN (K812894)Oxoid U.S.A., Inc.1981-11-06
B-D HEPARINIZED LONGDWEL I.V. CATHETER (K812137)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-11-06
MODEL RS 8300 (K812230)Renal Systems, Inc.1981-11-06
ZEE SURGICAL INSTRUMENTS (K812814)Zee Medical Products Co., Inc.1981-11-06
OXYTRON OXYGEN GENERATOR (K813018)Elmore Technology Corp.1981-11-06
VENTRONICS #5595 ECII OXYGEN ANALYZER (K812855)Ventronics, Div of Hudson Oxygen Therapy Sales Co.1981-11-06
ALT-QUANTICHROM (K812926)Abbott Laboratories1981-11-06
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D (K812916)General Diagnostics1981-11-06
TRONZO HIP (K812946)Biomet, Inc.1981-11-06
TRIDENT #2001 (K812769)Trident Surgical Corp.1981-11-06
VENTRONICS #5590 ECII OXYGEN MONITOR (K812854)Ventronics, Div of Hudson Oxygen Therapy Sales Co.1981-11-06
S/P CAPILLARY TUBES, HEPARINIZED (2A) (K812969)American Dade1981-11-06
S/P SURE-CAP (K812921)American Dade1981-11-06
FLUORICON L300 IMAGE INTENSIFIER (K812775)General Electric Co.1981-11-06
URIC ACID SYSTEM PACK TEST (K812978)Boehringer Mannheim Corp.1981-11-06
LIQUILYME BUN REAGENT (K812945)Amresco, Inc.1981-11-06
FETASONDE 5, #30, CENTRAL NURSING STAT (K812863)Kontron Instruments, Inc.1981-11-06
P.P.P. TREATMENT CABINET (K813003)Precision Professional Products1981-11-06
CLOTH SURGICAL GLOVES (K812735)Medical Synergy1981-11-06
MONOJECT PREFILLED SYRINGES (K812934)Sherwood Medical Co.1981-11-06
MA-2 VENTILATOR (K812980)Bio-Medical Repair, Inc.1981-11-06
RION AUDIOMETER AA-67 (K812951)Rion Acoustic Instruments, Inc.1981-11-06
FIBRI-FILTER 20 (K813001)Tri-Med, Inc.1981-11-06
RION AUDIOMETER AA-68 (K812952)Rion Acoustic Instruments, Inc.1981-11-06
STERILE BASIN SETS (K813012)Medspec Corp.1981-11-06
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Every clearance here is in the API, with alerts when new ones post.