Atlas FDA

1983

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

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RecordFirmDate
EPSILON IGE TEST KIT (K831987)Beckman Instruments, Inc.1983-10-14
CEFTIZOLIME 30 MCG SENSI-DISC (K832956)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-10-14
HEXOKINASE, GLUCOSE (K832872)Pointe Scientific, Inc.,1983-10-14
SERAYZER ALT/SGPT REAGENT STRIPS (K832791)Miles Laboratories, Inc.1983-10-14
DONALDSON-TYPE VENT TUBE (K832362)Concept, Inc.1983-10-14
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY (K832894)Gambro, Inc.1983-10-14
CEFUROXIME 30MCG. SENSITIVITY DISCS (K832909)Difco Laboratories, Inc.1983-10-14
CARDIAC OUTPUT COMPUTER (K831407)Ziehm International, Inc.1983-10-14
GROSHONG CATHETER, LONG TERM TYPE (K831386)Catheter Technology Corp.1983-10-14
SHABAN #9868 TUBING KIT-9870 STYLET (K832937)Shaban Mfg. Co.1983-10-14
URO-TEX MALE EXTERNAL CATHETER (K832450)Sierra Laboratories, Inc.1983-10-14
GRAVITY ENTERAL FEEDING SET (K832927)Medical Connections1983-10-14
BIOPLAR CORD -DISPOSABLE 30-1538 (K833015)Codman & Shurtleff, Inc.1983-10-14
PARAMAX PHOSPHORUS REAGENT (K833002)American Dade1983-10-14
CAMPYLOBACTER SELECTIVE SUPPLE-BLASER (K833019)Gibco Laboratories Life Technologies, Inc.1983-10-14
MONITORING KIT AMK-1 (K830778)Alternative Design Systems, Inc.1983-10-14
MICROSTAR VCI (K831766)Medionics International , Ltd.1983-10-14
MULTIPLE MANUAL SURGICAL INSTRUMENTS (K832686)Hirata Sangyo Co. USA, Inc.1983-10-14
PERCUTANEOUS TRACHEOSTOMY DEVICE (K832498)Frederic J. Toye, M.D.1983-10-14
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS (K832708)American Dade1983-10-14
RIA SOFTWARE (K832760)Kemble Instruments, Inc.1983-10-14
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (K832799)Syva Co.1983-10-14
SHABAN #9858 ASPIRATOR ASSEMBLE #9862- (K832932)Shaban Mfg. Co.1983-10-14
CLOSED SYS. DRAINAGE BAGS & TRAYS (K832822)Medline Industries, Inc.1983-10-14
AS 191 ECG TELEMETRY MODULE (K831429)Narco Scientific1983-10-14
CONCEPT T-TUBE (K832361)Concept, Inc.1983-10-14
MOUTH-TO-MOUTH SHIELD APPLICATOR (K832590)Mem, Inc.1983-10-14
NEPHROSS PRESTO (K832666)Organon Teknika Corp.1983-10-14
WINGED INFUSION SET (K832622)Top Surgical Manufacturers Co.1983-10-14
TOTAL IRON-BINDING CAPACITY ACCESORY (K832759)Seragen Diagnostics, Inc.1983-10-14
DALE ENDOTRACHEAL TUBE HOLDER (K832946)Dale Medical Products, Inc.1983-10-14
PARAMAX & GLUTAMYTRANSFERASE REAGENT (K833001)American Dade1983-10-14
CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW (K833018)Gibco Laboratories Life Technologies, Inc.1983-10-14
ALBUMIN REAGENT SET (K832747)Biorent Diagnostic, Inc.1983-10-14
SENSORY ROLLER MASSAGER (K833090)Maddak, Inc.1983-10-14
PARAMAX TOTAL BILIRUBIN REAGENT (K833004)American Dade1983-10-14
TOP DISPOSABLE PLASTIC SYRINGES (K832621)Top Surgical Manufacturers Co.1983-10-14
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD (K832896)Biodan Medical Systems, Ltd.1983-10-14
E-Z FIT (K831287)Triad Medical Division1983-10-14
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN (K832915)Surgitek1983-10-14
ENZYMUNE-TEST TSH (K832823)Icl Scientific1983-10-14
SHERIDAN/LEVI-A-SUMP (K832196)Sheridan Catheter Corp.1983-10-14
ZIMMER OSSIMETER (K832899)Zimmer, Inc.1983-10-14
MARK V HIGH VOLTAGE GALVANIC STIMULATORR (K832546)Orthion Corp.1983-10-14
CEFUROXIME 30MCG. SUSCEP DISK (K832653)General Diagnostics1983-10-14
LIQUID CHROMATOGRAPH 1090 SERIES (K832375)Hewlett-Packard Co.1983-10-14
CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER (K833020)Gibco Laboratories Life Technologies, Inc.1983-10-14
ABBOTT IGE EIA (K832360)Abbott Laboratories1983-10-14
CUSTOM KWIK SET AND/OR PAK (K832517)Norton Texas Medical Products1983-10-14
REFEREE BLOOD GAS ANALYZER-ELECTRODES (K832779)Analytical Products, Inc.1983-10-14
LIPASE HYDROLYSIS/GLYCEROL KINASE (K832871)Pointe Scientific, Inc.,1983-10-14
FRAZIER SUCTION INSTRUMENT-DISPOS (K832636)Pilling Co.1983-10-14
SERALYZER AST/SGOT REAGENT STRIPS (K832790)Miles Laboratories, Inc.1983-10-14
MASTERHINGE (K833084)Mark One Healthcare Products1983-10-14
BLOOD GAS QUALITY CONTROL SOFT-86000F (K831574)Computermate, Inc.1983-10-14
EASYTOUCH BUN REAGENT SET (K832749)Worthington Diagnostic Systems1983-10-14
AS 1740 INTERFACE MODULE (K831428)Narco Scientific1983-10-14
HEMOCHRON THROMBOCHRONOMETER (K832189)International Technidyne Corp.1983-10-14
PATIENT SELECTOR FUNCTION BLOCK (K832212)Honeywell, Inc.1983-10-14
SHABAN #9852 CHIMNEY-#9854 SCREEN & (K832931)Shaban Mfg. Co.1983-10-14
TOP DISPOS. INFUSION SET/HEMODIALY (K832623)Top Surgical Manufacturers Co.1983-10-14
EASYTOUCH TROMBOPLASTIN REAGENT (K832427)Worthington Diagnostic Systems1983-10-14
SHABAN #9850 PUMP WINDINGS-9860 FILTER (K832936)Shaban Mfg. Co.1983-10-14
MICRO-EDGE DISPOSABLE BLADES (K832680)Micromedics, Inc.1983-10-14
COMPUR* EASY TOUCH URIC ACID REAGENT (K832785)Worthington Diagnostic Systems1983-10-14
DUAL FLOW NEEDLE (K832136)Travenol Laboratories, S.A.1983-10-14
COMPUR* EASYTOUCH TOTAL BILIRUBIN (K832748)Worthington Diagnostic Systems1983-10-14
GOAL TENDER (K832878)Dna Medical, Inc.1983-10-14
DIALYZER PREPARATION SYS DPS-4 (K832230)Seratronics, Inc.1983-10-14
TECHNICON PARACUT (K833071)Technicon Instruments Corp.1983-10-14
AIR UTERINE DISPLACER-AUD 120 (K833022)Scientific Sales Intl., Inc.1983-10-14
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (K831424)Extracorporeal Medical Specialities, Inc.1983-10-14
TOP STERILE DISPOS. HYPODERMIC NEEDLES (K832626)Top Surgical Manufacturers Co.1983-10-14
TISSUE TRANSPORT MEDIUM (K833016)Northern Scientific, Inc.1983-10-14
KEMTEK 400 RIA GAMMA COUNTER (K832734)Kemble Instruments, Inc.1983-10-14
MAXITHINS UNSCENTED PANTY SHIELDS (K832974)Tampax, Inc.1983-10-14
MODIFICA-OF EMIT AED PRIMIDONE ASSAY (K832798)Syva Co.1983-10-14
FIAX IGG TEST (K832821)Intl. Diagnostic Technology1983-10-14
MICROSTAR VC1 VOLUMETRIC CYCLER (K832141)Medionics International , Ltd.1983-10-14
CEFUROXIME 30 MCG SENSI-DISC (K832515)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-10-14
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR (K831633)Intermedics, Inc.1983-10-12
EGS MODEL 300 (K832371)Electro-Med Health Industries, Inc.1983-10-06
STRAIGHT STEM FEMORAL HEAD PROSTHESIS (K831851)Proteck, Inc.1983-10-06
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC (K831962)Abbott Laboratories1983-10-05
VITAMIN B12 FOLATE CA-1515-125 (K832711)Clinical Assays, Inc.1983-10-04
ARTHROSCOPY FLUID MGMT. SYSTEM (K832315)3M Health Care, Sarns1983-10-04
BRILLIANT GREEN AGAR PLATE (K832536)Otisville Biotech, Inc.1983-10-04
HOT PROBE MODEL 6001 (K832179)Analytic Technology1983-10-04
RIME COLI KIT (K832587)Austin Biological Laboratories1983-10-04
IRRIGATION/ASPIRATION PACK (K832525)Intermedics Intraocular, Inc.1983-10-04
FETAL MONITOR #FM-2 (K832849)Advantage Medical Systems, Inc.1983-10-04
SERALYZER TRIGLYCERIDES REAGENT STRIPS (K832684)Miles Laboratories, Inc.1983-10-04
NEO-FLOAT NEONATAL FLOTATION SYS & RHYT (K832829)Clinical Data Instruments, Inc.1983-10-04
I-GLIDE IOL IMPLANTATION AID (K832939)I For M, Inc.1983-10-04
HANDY IIM (K833039)Shofu Dental Corp.1983-10-04
SUMMA DISK (K833038)Shofu Dental Corp.1983-10-04
SIAS IRRIGATION/ASPIRATION SYSTEM (K832413)Clark Pool & Assoc.1983-10-04
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN (K832949)Coopercare, Inc.1983-10-04
EMIT AED CARBAMAZEPINE ASSAY (K832720)Syva Co.1983-10-04
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI (K832893)Cook Pacemaker Corp.1983-10-04
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Every clearance here is in the API, with alerts when new ones post.