Atlas FDA

1993

4,167 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS (K932408)Baxter Healthcare Corp1993-09-28
USCI SUPER 6 6F PTCA GUIDING CATHETER (K933019)C.R. Bard, Inc.1993-09-28
TECHMEDICA STANDARD BIPOLAR SYSTEM (K925420)Techmedica, Inc.1993-09-28
MAYFIELD ADULT DISPOSABLE SKULL PIN (K932860)Ohio Medical Instrument Co., Inc.1993-09-28
CFM-800 COLOR FLOW MAPPING SYSTEM (K924079)Diasonics, Inc.1993-09-28
EVACUATOR, ORAL CAVITY (K932824)Den-Tal-Ez Mfg Co., Inc.1993-09-28
SURFAS (K925081)D.O. Weaver and Co.1993-09-28
INTHERM STASIS VALVE SYSTEM (K931025)Interventional Therapeutics Corp.1993-09-28
PARI FILTER/VALVE SET (K926455)Paul Ritzau Pari-Werk GmbH1993-09-28
EDGE SYRINGES AND NEEDLES (K923321)Trico Intl., Inc.1993-09-28
ULTRA COMPACT VIDEO IMAGER (K930755)International Imaging Electronics1993-09-28
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (K931201)Tri-Med Specialties, Inc.1993-09-28
KODAK XML 300 DARKROOM FILM FEEDER (K933001)Eastman Kodak Company1993-09-28
HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW (K933058)Heartware Intl. Corp.1993-09-28
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT (K932758)Medix Biotech, Inc.1993-09-28
MAYFIELD* A-2000 SKULL CLAMP (K932807)Ohio Medical Instrument Co., Inc.1993-09-28
CARDIOMETRICS FLOWIRE & FLOMAP (K932536)Cardio Metrics, Inc.1993-09-28
MODIFIED LUER (K931833)Medi-Dyne, Inc.1993-09-28
SYNELISA CORTISOL (K931177)Elias U.S.A., Inc.1993-09-27
VITAL-PORT MINI VASCULAR ACCESS SYSTEM (K931586)Med Institute, Inc.1993-09-27
CALCIUM TEST ITEM NUMBER 65409 (K932158)Em Diagnostic Systems, Inc.1993-09-27
VITAPEN (K924447)Vitajet Corp.1993-09-27
LAP CHOLY TRAYS (PACKS) (K932220)Associated Medical Products Co.1993-09-27
SELEC-3 (K925645)Biomedix, Inc.1993-09-27
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (K925248)Kontron Instruments, Inc.1993-09-27
EZ PUMP (K926446)Alphamed, Inc.1993-09-27
URIC ACID TEST ITEM NUMBER 65422 (K932162)Em Diagnostic Systems, Inc.1993-09-27
UREA KIT (K923506)Randox Laboratories, Ltd.1993-09-27
BIOCLOT LA (K932463)Biopool AB1993-09-27
OPTI-PLAST 5F PTA CATHETERS (K933483)Vas-Cath, Inc.1993-09-24
IMMULITE BETA-2-MICROGLOBULIN (K931702)Diagnostic Products Corp.1993-09-24
INSUFFLATOR TUBING KIT (K922197)O.R. Concepts, Inc.1993-09-24
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK (K933648)Dupont Medical Products1993-09-24
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS (K932685)Baxter Diagnostics, Inc.1993-09-24
ENZYMATIC CO2 REAGENT, MODIFICATION (K932267)Intersect Systems, Inc.1993-09-24
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 (K933435)Baxter Diagnostics, Inc.1993-09-24
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN (K932850)Helix Diagnostics, Inc.1993-09-24
ROCHE ABUSCREEN ONLINE FOR METHADONE (K930928)Roche Diagnostic Systems, Inc.1993-09-24
SUCTION GUILLOTINE DEVICE (K932142)Triton Technology, Inc.1993-09-24
SYNELISA CENP-B ANTIBODIES (K931255)Elias U.S.A., Inc.1993-09-24
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES (K933744)Sa Scientific, Inc.1993-09-24
MICROSNARE (K925439)Microvena Corp.1993-09-24
DIAGNOSTIC INTRAVASCULAR CATHETER (K930758)Applied Medical Resources1993-09-24
GC II AGAR WITH ISOVITALEX (K932882)Becton Dickinson Microbiology Systems1993-09-24
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR (K921957)Hewlett-Packard Co.1993-09-24
INSUFFLATOR TUBING/FILTER KIT (K922244)O.R. Concepts, Inc.1993-09-24
TOXI*LAB LTD OPIATE SYSTEM (K932209)Toxi-Lab, Inc.1993-09-24
VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 (K926108)Vingmed Sound, Inc.1993-09-24
HEWLETT PACKARD MODEL M1353A FETAL MONITOR (K921956)Hewlett-Packard Co.1993-09-24
A MANO TONGUE CLEANSER (K932839)A Mano Products, Ltd.1993-09-23
POLYP SNARE NET W/MONOPOLAR CAUTERY (K926103)United States Endoscopy Group, Inc.1993-09-23
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM (K931978)Sharplan Lasers, Inc.1993-09-23
ENDOSI SUCTION IRRIGATOR (K923201)Armm, Inc.1993-09-23
DIOMED 25 25W SURGICAL DIODE LASER (K931212)Dio-Med Corp.1993-09-23
OMNI-MATRIX (K930151)Innovative Technology , Ltd.1993-09-23
ANATOMICAL TYPE KNEE SYSTEM (K922859)Osteo Technology, Inc.1993-09-23
DISPOSABLE INSUFFLATION TUBING (K932045)L.A.S.E.R., Inc.1993-09-23
ELECTROSURGICAL ELECTRODE (K932102)Megadyne Medical Products, Inc.1993-09-23
MODEL 6400 ABC ELECTROSURGERY GENERATOR (K933332)William E. Mckay1993-09-23
HGM SCANMAN PLUS (K933333)Hgm, Inc.1993-09-23
CENATOR TOTAL HIP SYSTEM (K925866)Corin Orthopedic Products1993-09-23
SURGICAL TROCAR AND CANNULA (K932995)Applied Medical Resources1993-09-23
HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300 (K930420)Hunter Fan Co.1993-09-23
QB II BLUNT DISSECTOR (K933604)Joyce M. Shotwell, M.D.1993-09-23
ESB 2400 SEI (K933146)Esb, Inc., Div. of Ray-O-Vac1993-09-23
LATEX EXAMINATION GLOVE (K930557)Ezmt Valve Co., Inc.1993-09-23
MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT (K931197)Meddev International Corp.1993-09-23
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (K926002)Alamar Biosciences Laboratory, Inc.1993-09-23
INSUFFLATION TUBING (K925691)Mectra Labs, Inc.1993-09-23
ALPHA-DENT CORE BUILDUP PASTE (K932827)Alpha-Dent1993-09-23
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L (K931411)Medtronic Vascular1993-09-23
CARDIAC THERAPHY SYSTEM SCP 900 (K921666)Ppg Hellige B.V.1993-09-23
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI (K933188)Baxter Diagnostics, Inc.1993-09-22
NORODYN 2000 ELECTROMYOGRAPH (K922838)Noromed, Inc.1993-09-22
ON-LINE ANALYSIS SYSTEM (K930639)Softheart, Inc.1993-09-22
HEMOSTASIS VALVE AND TUBING SET (K930194)Opticon Medical, Inc.1993-09-22
GERTIE MARX NEEDLE (K931644)Intl. Medical-Dental Products USA, Inc.1993-09-22
ANTI-DISCONNECTION MECHANISM (K933781)Hammer-Plane, Inc.1993-09-22
INTIMA POINT GUARD INTRAVASCULAR CATHETER (K923702)Becton Dickinson Vascular Access, Inc.1993-09-22
NOVUS MULTIWAVELENGTH (K932468)Coherent Medical Group1993-09-22
INTROPEEL (K930801)Menlo Care, Inc.1993-09-22
INTROPEEL V (K931218)Menlo Care, Inc.1993-09-22
BIOSCOPE (K923406)Biotronik, GmbH & Co.1993-09-22
COBAS CORE FSH EIA (K930304)Roche Diagnostic Systems, Inc.1993-09-21
THE NATURAL-KNEE REVISION (K930554)Intermedics Orthopedics1993-09-21
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES (K932178)Tosoh Medics, Inc.1993-09-21
G C II AGAR WITH SENSIVITALEX (K932879)Becton Dickinson Microbiology Systems1993-09-21
BARD URODYNAMIC CATHETER (K924714)C.R. Bard, Inc.1993-09-21
SELBY INSTRUMENTATION (K924474)Advanced Spine Fixation Systems, Inc.1993-09-21
BIOPRO MODULAR TIBIAL TRAY (K922841)Biopro, Inc.1993-09-21
CEDIA VALPORIC ACID ASSAY (K930734)Microgenics Corp.1993-09-21
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 (K932159)Em Diagnostic Systems, Inc.1993-09-21
OLYMPUS CREATININE REAGENT (K931939)Olympus Corp.1993-09-21
THE SAMUELS RETROGRAD VALVULOTOME (K932009)Vascutech, Inc.1993-09-21
FENWAL 40 MICRON TRANSFUSION FILTER (K931441)Baxter Healthcare Corp1993-09-21
ACE CLINICAL CHEMISTRY SYSTEM (K931786)Schiapparelli Biosystems, Inc.1993-09-21
RMHS POROUS DISTAL SLEEVE (K930108)Smith & Nephew Richards, Inc.1993-09-21
SPECTACLE FRAME (K933874)Designer Frames1993-09-20
PULPDENT SEAL-RITE LOW VISCOSITY (K932794)Pulpdent Corp.1993-09-20
STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN (K933424)Zyloware Corp.1993-09-20
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Every clearance here is in the API, with alerts when new ones post.