Atlas FDA

1983

3,564 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CMS 2000 SERIES TPN KITS (K831964)Currie Medical Specialties, Inc.1983-08-11
ANTI-N DNA ANTIBODY TEST KIT (K832031)Breit Laboratories, Inc.1983-08-11
EDSLAB PRESSURE GAUGE (K832323)American Edwards Laboratories1983-08-11
PANASONIC MODEL EW-213 (K831151)Panasonic Co. Div. Matsu Elec. Corp. America1983-08-11
TOTAL CO2 REAGENT SET (K832071)American Research Products Co.1983-08-11
MERITEC-STREP GROUP A BETA-HEMOLYTIC (K831599)Meridian Diagnostics, Inc.1983-08-11
EYE MUSCLE SLEEVES (K831726)S. Jackson, Inc.1983-08-11
DENTAL ELECTRONIC/S.B.R TRADING BU HAND (K831824)Silverman'S1983-08-11
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS (K831924)Electro-Nucleonics Laboratories, Inc.1983-08-11
DISPOSABLE PRESSURE TRANSDUCER#14004195 (K831698)Norton Performance Plastics Corp.1983-08-11
UCG-BETA SLIDE MONOCLONAL (K831775)Armkel, LLC1983-08-11
BILIRUBIN CALIBRATORS & CONTROL (K832094)Gilford Diagnostics1983-08-11
POLYCHACO INDIRECT IMMUNOFLUORESCENCE (K830869)Parasitic Disease Consultants1983-08-11
CARDIOPLEGIA RESERVOIR-#500926 (K831966)American Bentley1983-08-11
EMPTY DIALYSATE CONTAINER (K831689)Delmed, Inc.1983-08-11
FETAL MONITOR #115 (K831852)Ge Medical Systems Information Technologies1983-08-11
PHENOBARTIAL ASSAY USE ON COBAS-BIO (K832097)Syva Co.1983-08-11
AQUEOUS BLOOD GAS CONTROL LEVEL I,II & (K832003)American Dade1983-08-10
FOLEY-TEMP (K831567)Mallinckrodt Critical Care1983-08-10
UNIVERSAL CORONARY CANNULA (K831330)Possis Medical, Inc.1983-08-10
STAT-TRAK LIQUID ELECTROLYTE CONTROL (K831389)United Diagnostics, Inc.1983-08-10
URINE BAG SYSTEM (K831796)I M, Inc.1983-08-08
IMPROVED SILICATH SILICONE ELASTOMER (K832165)Travenol Laboratories, S.A.1983-08-08
DATA-ZYME URIC ACID PROCEDURE (K831983)Data Medical Associates, Inc.1983-08-08
AMS MALLEABLE PENILE PROSTHESIS (K831660)American Medical Systems, Inc.1983-08-08
PNEUMATIC/ELECTRIC/HYDRAULIC BED (K831821)G.W. Healthcare, Inc.1983-08-08
MEDION MI-200 IONTOPHORETIC MEDICATOR (K831000)Etherington Industries1983-08-08
COMPUDIAL/KP-1 (K831132)Computer Dialysis Systems, Inc.1983-08-08
VENOUS CATHETER (K832064)Cardio Search, Inc.1983-08-08
EMIT AMD GENTAMICIN ASSAY (K832056)Syva Co.1983-08-08
TRENDO-SCOPE (K831995)Gabriel Ent.1983-08-08
MULTI-TITER DISPENSER (K832203)Hamilton Co.1983-08-08
QUANTIGEN T & B CELL ASSAY (K831053)Bio-Rad1983-08-08
INJECTION SEALING CAP 13791 (K830541)Quinton, Inc.1983-08-08
AUTO SUTURE POLY SURGICLIP HEMOSTATIC (K831457)United States Surgical, A Division of Tyco Healthc1983-08-08
BIOCHECK POSITIVE URINE CONTROL (K831994)Helena Laboratories1983-08-08
WASHER 6000 MICRO-C LISA SYSTEM (K831640)Organon Teknika Corp.1983-08-08
METAL-BACKED ACE TABULAR CUP (K831986)Kirschner Medical Corp.1983-08-08
MODEL 327T UNIPOLAR CARDIAC PULSE GEN (K832052)Cook Pacemaker Corp.1983-08-08
LEGIONELLA IFA KIT I (K831760)Bionetic Laboratory Products1983-08-08
ALLERGEN IMMUNOSORBENTS IP SPECIFIC E (K831496)Diagnostic Reagent Tech.1983-08-08
ENTERNAL PUMP & ADMIN. SET 430 (K831935)Imed Corp.1983-08-08
EMIT CAD QUINIDINE ASSAY FOR USE W/ (K832096)Syva Co.1983-08-08
SELF-SEAL STERILIZATION POUCHES (K832128)Medical Industries Packaging, Inc.1983-08-08
EPINEED EPIDURAL CATHETER (K832232)Terumo Medical Corp.1983-08-08
IMMULON SUBSTRATE REMOVAWELL STRIPS (K832117)Dynatech Corp.1983-08-08
NML-5010/5020 MULTI-DETECTOR SYSTEM (K832002)Nuclear Medical Laboratories, Inc.1983-08-08
GAMMA STERILIZED CAPILLARY FLOW DIALYZ (K831940)Travenol Laboratories, S.A.1983-08-08
ARGYLE YANKAVER SUCTION TUBE W/CONTROL (K832027)Sherwood Medical Co.1983-08-08
VISIDEX II REAGENT STRIPS (K831989)Miles Laboratories, Inc.1983-08-08
EMIT ASSAY AND TOBRAMYCIN (K832055)Syva Co.1983-08-08
PRESSURE MONITOR & CONTROL UNIT APC-02A (K831402)Parker Hannifin Corp.1983-08-08
CMV RQ BIO-ENZABEAD KIT (K831343)Litton Bionetics1983-08-08
EPINEED EPIDURAL NEEDLE (K832233)Terumo Medical Corp.1983-08-08
PENTAX FD-34A DUODENOFIBERSCOPE (K832006)Pentax Precision Instrument Corp.1983-08-01
PIPETTE 12 CHANNEL (K831644)Organon Teknika Corp.1983-08-01
EMIT AAD THEOPHYLLINE ASSAY (K832034)Syva Co.1983-08-01
BRONCHO-FIBERSCOPE (K832010)KARL STORZ Endoscopy-America, Inc.1983-08-01
PHONIC EAR PE 467R-PE 461T (K832080)Phonic Ear, Inc.1983-08-01
CLINOVATIVE II DIAGNOSTIC KIT (K831837)Pierce Chemical Co.1983-08-01
SPLINT WOOD (K832144)Vermont Wood Industries, Inc.1983-08-01
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (K832074)CooperVision, Inc.1983-08-01
PULSAR #B SINGLE CHANNEL TENS-PULSAR D (K831950)Spembly Medical , Ltd.1983-08-01
AMBULIZER MODEL MC-5 (K832161)Mobilizer Medical Products, Inc.1983-08-01
PHONIC EAR PE 845PPC-D (K832081)Phonic Ear, Inc.1983-08-01
EMIT AED PHENYTOIN ASSAY (K832033)Syva Co.1983-08-01
DICON GLAUCOMA DIAG. CENTER 2000 SERIES (K832142)CooperVision, Inc.1983-08-01
LKB 2164 MACRO-SPIN R CENTRIFUGE (K831942)Lkb Instruments, Inc.1983-07-29
EMBEDDING RING (K831922)Polymer Technology Corp.1983-07-29
LKB 2160 MIDISPIN CENTRIFUGE (K831947)Lkb Instruments, Inc.1983-07-29
DISPOSABLE MICROTOME BLADES (K831921)Polymer Technology Corp.1983-07-29
LKB 2161 MIDISPIN R CENTRIFUGE (K831948)Lkb Instruments, Inc.1983-07-29
PROSTHETIC RINGS #4400 MITRAL & 4500 (K831949)American Edwards Laboratories1983-07-29
VITALINE 2 (K822856)American Heartline, Inc.1983-07-29
DIA STRIPS SYSTEM (K831623)California Immuno Diagnostic, Inc.1983-07-28
MODEL 947 VIDEO BLOOD GAS SYS (K831379)Avl Scientific Corp.1983-07-28
LIFESTAT 200 (K831232)Physio-Control Corp.1983-07-28
REVOLUTION RADIAL IMMUNODIFFUSION PLATE (K831811)Calbiochem-Behring Corp.1983-07-28
UNICUFF-BLOOD PRESSURE CUFF (K831001)Frontier Products1983-07-28
SILCATH CENTRAL CATHETER TRAY W/18 GA (K831453)Argon Medical Corp.1983-07-28
SODIUM HYPOCHLORITE 3% (K831620)Omega Medical Diagnostics1983-07-28
MACLEAN-FOGG, DISP. BASE MOLD (K831900)Polymer Technology Corp.1983-07-28
PRO QUANTUM (K831249)Abbott Laboratories1983-07-28
KENNEDY TIBIAL COMPONENT (K831513)Biomet, Inc.1983-07-28
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC (K831866)Varian Assoc., Inc.1983-07-28
COMPOSI-GLAZE (K831484)Denpac Corp.1983-07-28
COMPACT FOUR (K831896)Nicolet Biomedical Instruments1983-07-28
CO-OXIMETER CONTROL (K831813)United Diagnostics, Inc.1983-07-28
TISSUE-TEK V.I.P. 100/200 (K831313)Miles Laboratories, Inc.1983-07-28
SAVE-A-BAKE PORCELAIN POLISH (K831483)Denpac Corp.1983-07-28
AMBULATORY ECG EVENT RECORDER (K830907)Brentwood Instruments, Inc.1983-07-28
CALIBRATION STANDARD-HEMOGLOBIN (K831814)United Diagnostics, Inc.1983-07-28
INTRA-ORAL ARTIFICIAL LARYNX (K831127)Xomed, Inc.1983-07-28
TRICYCLIC ANTIDEPRESSANTS (K831736)Utak Laboratories, Inc.1983-07-28
SICKLE-HEME A/S CONTROLS & A/A CONTROL (K831871)Anco Medical Reagents & Assoc.1983-07-28
HATCH KIT (K831855)Radioassay Systems Laboratories, Inc.1983-07-28
DNA FLOR (K831408)Medastat Scientific Corp.1983-07-28
SODIUM HYPOCHLORITE 7% (K831619)Omega Medical Diagnostics1983-07-28
LYOPHILIZED MICROORGANISMS (K831653)Austin Biological Laboratories1983-07-28
MODIFIED SOYBEAN CASEIN DIGEST BROTH (K831671)Isle Media and Sterile Products, Inc.1983-07-28
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