Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CPR PROMPT (K954692)County Line , Ltd.1996-03-27
MODULAR ACETABULAR SHELL II (K955739)Intermedics Orthopedics1996-03-27
WESTMED CIRCULARIE PEP DEVICES (K955047)Westmed Intl.1996-03-27
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM (K955365)Sofamor Danek USA,Inc.1996-03-27
STERILE KIRSCHNER WIRES AND STEINMANN PINS (K960385)Depuy, Inc.1996-03-27
KIS MT4 (K960111)The Implant Center of the Palm Beaches1996-03-27
REFLECTION DUAL DIMENSION SHELL (K960094)Smith & Nephew Richards, Inc.1996-03-27
MANAN MALECOT BASKET DRAINAGE CATHETER (K954147)Manan Medical Products, Inc.1996-03-26
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET (K953945)Dlp, Inc.1996-03-26
FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER (K955818)Quest Medical, Inc.1996-03-26
STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (K960007)Storz1996-03-26
RMI INTERNAL MAMMARY ARTERY CANNULA (K960098)Research Medical, Inc.1996-03-26
MANAN MANTA CATHETER FIXATION DISK (K954132)Manan Medical Products, Inc.1996-03-26
MANAN GENERAL UTILITY DRAINAGE CATHETER (K953713)Manan Medical Products, Inc.1996-03-26
MANAN UNIVERSAL SUMP DRAINAGE CATHETER (K953601)Manan Medical Products, Inc.1996-03-26
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR (K960251)Aristo Medical Products, Inc.1996-03-26
MANAN BILIARY DRAINAGE CATHETER (K954043)Manan Medical Products, Inc.1996-03-26
MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (K955839)Baxter Edwards1996-03-25
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS (K960291)Ocu-Ease Optical Products, Inc.1996-03-25
PERCEPTOR COMPENSATOR MORSE MANIFOLD (K951722)Namic1996-03-25
STRYKER ADEL BASSINET (K960012)Stryker Corp.1996-03-25
PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES (K951876)Xintec Corporation1996-03-25
CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT (K960148)Cabot Medical Corp.1996-03-25
K2 BONE SCREW SYSTEM (K960537)Kinetikos Medical, Inc.1996-03-25
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (K960224)Rg Ent., Inc.1996-03-25
PROTEC ROLL GAUZE (K960093)Derivadas Degasa S.A. DE C.V.1996-03-25
PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES (K951935)Xintec Corporation1996-03-25
CORDIS VENTRICULAR ANTECHAMBER (VA) (K955832)Cordis Corp.1996-03-25
NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR (K955900)Novavision, Inc.1996-03-25
BRAUN HEMOSTASIS INTRODUCERS (K955820)B.Braun Medical, Inc.1996-03-25
K3 BONE SCREW SYSTEM (K960533)Kinetikos Medical, Inc.1996-03-25
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) (K950314)Dantec Medical, Inc.1996-03-25
MUELLER HINTON AGAR WITH 2% NACI (K960313)Remel, L.P.1996-03-25
CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER (K955817)Cordis Webster, Inc.1996-03-25
A-DEC PERFORMER CONTROL UNIT (K960506)A-Dec, Inc.1996-03-25
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE (K955869)Scimed Life Systems, Inc.1996-03-22
900UDX URINE PATHOLOGY SYSTEM (K960054)Intl. Remote Imaging Systems1996-03-22
MULTI III, IV (K955860)Excel Tech. , Ltd.1996-03-22
NORTHO BONE SCREW (K925872)Northo Orthopedics1996-03-22
AMALGAMIBOND PLUS (K960879)Parkell, Inc.1996-03-22
SCHUHLI IMPLANT SYSTEM (K954963)Synthes (Usa)1996-03-22
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT (K955871)Howmedica Corp.1996-03-22
HYTEC AUTOIMMUNE KITS (RNP) (K954897)Hycor Biomedical, Inc.1996-03-22
ALTA CFX IM ROD SYSTEM (K960524)Howmedica Corp.1996-03-22
BEST PREGNANCY TEST (K953606)Ameritek, Inc.1996-03-22
LONG LIFE RX-12 (K960295)Rexton, Inc.1996-03-22
ANTI-KERATIN-HMW PRIMARY ANTI-BODY (K941173)Ventana Medical Systems, Inc.1996-03-22
HYTEC AUTOIMMUNE KITS (SM) (K954896)Hycor Biomedical, Inc.1996-03-22
LEKSELL NEURO GENERATOR AND ACCESSORIES (K941823)Elekta Instruments, Inc.1996-03-22
ALTACARE (K955874)Asf Industries, Inc.1996-03-22
DOCUMENT TDM ULTRA ASSAYED CONTROL (K960244)Casco Standards1996-03-22
RETINOL BINDING RID KIT (K955881)The Binding Site, Ltd.1996-03-22
BINAX STREP A TEST (K960712)Binax, Inc.1996-03-22
ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE (K960565)Dent Zar, Inc.1996-03-22
HEMATIL 18 (H-18) (K953643)Texas Intl. Laboratories, Inc.1996-03-22
CPR GENERAL SURGERY TRAY (K960241)Custom Pack Reliability1996-03-22
ISOTRON III, ISOTRON IV (K955387)Excel Tech. , Ltd.1996-03-22
KERATIN PRIMARY ANTIBODY (K935161)Ventana Medical Systems, Inc.1996-03-22
A2 DETACHED DUAL PORT SYSTEM (K955819)Arrow Intl., Inc.1996-03-21
ES-3800, VIDEO SIGMOIDOSCOPE (K951577)Pentax Precision Instrument Corp.1996-03-21
ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) (K955838)Atrix Laboratories, Inc.1996-03-21
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS (K946168)Ivac Corporation1996-03-21
INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER (K954338)Innovasive Devices, Inc.1996-03-21
DISCOGRAPHY KIT (K960082)Spinal Specialties, Inc.1996-03-21
ENDOSCOPIC ACCESS DEVICE (K960232)Applied Medical Technologies1996-03-21
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433 (K951832)Vasamedics, LLC1996-03-21
CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION) (K960428)Carrington Laboratories, Inc.1996-03-21
PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (K955790)Trylon Corp.1996-03-21
DUAL SPRAY MINISPACER (K955805)Thayer Medical Corp.1996-03-21
EC-3800L, VIDEO COLONOSCOPE (K951574)Pentax Precision Instrument Corp.1996-03-21
MAXCESS NEEDLE FREE CONNECTOR (8200) (K960661)Solopak Medical Products, Inc.1996-03-21
VASCULAR ACCESS PORT KIT (K955587)Boston Scientific Corp1996-03-21
DELTA 16 (K955411)Instrumentarium Imaging, Inc.1996-03-21
CONMED SELECT ONE LAPAROSCOPY ELECTRODE (K960808)Conmedcorp1996-03-21
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM (K955789)Alcon Laboratories1996-03-21
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER (K960426)Medical Components, Inc.1996-03-21
SSA-340A (MODIFICATION) (K960602)Toshiba America Medical Systems, In.C1996-03-21
LACERATION TRAY (K960520)Medco Instruments, Inc.1996-03-21
EC-3800TL, VIDEO COLONOSCOPE (K951579)Pentax Precision Instrument Corp.1996-03-21
EPIX XL TENS UNIT (K951903)Empi1996-03-20
PERMAMESH HYDROXYLAPATITE MATRIX (K960362)Ceramed Corp.1996-03-20
KIS MT3 (K960110)The Implant Center of the Palm Beaches1996-03-20
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM (K960182)Mardx Diagnostics, Inc.1996-03-20
S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM) (K955164)Habley Medical Technology Corp.1996-03-20
HYTEC AUTOIMMUNE KITS (SCL-70) (K954894)Hycor Biomedical, Inc.1996-03-20
TRI-COUNT 20 (K960471)Hematronix, Inc.1996-03-20
CELL RECOVERY SYSTEM (K960004)Medical Device Technologies, Inc.1996-03-20
ORTHOFIX MODULSYSTEM (K955848)Orthofix, Inc.1996-03-20
ORGENTEC ENASCREEN ELISA ASSAY (K955134)Orgentec1996-03-20
LXN FRUCTOSAMINE TEST (K955629)Lxn Corp.1996-03-20
ORGENTEC ENASCREEN PIN IMMUNO ASSAY (K955133)Orgentec1996-03-20
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (K960091)Helix Diagnostics, Inc.1996-03-20
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951799)Light Diagnostics1996-03-20
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS (K953896)Imed Corp.1996-03-20
HYTEC AUTOIMMUNE KIT (JO-1) (K954895)Hycor Biomedical, Inc.1996-03-20
HYTEC AUTOMIMMUNE KIT (DS-DNA) (K954893)Hycor Biomedical, Inc.1996-03-20
INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 (K960883)Taut, Inc.1996-03-20
CPR MICROMASK WITH OXYGEN INLET (K953414)Plasco, Inc.1996-03-20
SPACELINE FEEL 21 (K953865)J. Morita USA, Inc.1996-03-20
HALL MODULAR ACETABULAR REAMER SYSTEM (K960852)Linvatec Corp.1996-03-20
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Track 1996 automatically

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