Atlas FDA

1996

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

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RecordFirmDate
OMICRON MONITOR, DELTA MONITOR (K960861)Core-M, Inc.1996-08-19
PHILIPS MULTIDIAGNOST 4 (K961374)Philips Medical Systems, Inc.1996-08-19
MPO ELISA TEST SYSTEM (K961765)Immunoprobe, Inc.1996-08-19
ZWEYMUELLER SL FEMORAL HIP STEM (K962101)Intermedics Orthopedics1996-08-19
ILIZAROV EXTERNAL FIXATION SYSTEM (K962808)Smith & Nephew Richards, Inc.1996-08-19
QUALITROL CRP CONTROL SET (K961829)Consolidated Technologies, Inc.1996-08-19
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K962186)Genzyme Corp.1996-08-19
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES (K962069)Medline Industries, Inc.1996-08-19
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) (K962353)Princeton BioMeditech Corp.1996-08-19
IMPLANTECH WM NASAL-LABIAL IMPLANT (K962261)Implantech Associates, Inc.1996-08-19
PRO-FECT STERILE GAUZE SPONGES (K962227)Network Trading Corp. Dba Grand Intl.1996-08-19
PR-3 ELISA TEST SYSTEM (K961764)Immunoprobe, Inc.1996-08-19
AXSYM TOXO IGG ANTIBODY ASSAY (K954575)Abbott Laboratories1996-08-16
SAFESTRIP (K955107)Firehouse Medical, Inc.1996-08-16
PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE (K961357)Intelligent Product Limited Co.1996-08-16
THE BIOPLATE FIXATION SYSTEM (K961976)Biomedics1996-08-16
SEIRIN ACUPUNCTURE NEEDLES (K962809)Seirin-America, Inc.1996-08-16
PROSPORE II (K960790)Raven Biological Laboratories, Inc.1996-08-16
MICROLAB 4000, MICROLAB 4200 (K961896)Hamilton Co.1996-08-16
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K962150)Dade Intl., Inc.1996-08-16
PATIENT MONITOR MODEL 405P (K955546)Ivy Biomedical Systems, Inc.1996-08-16
ACTIVE ANDROSTENEDIONE EIA (K963002)Diagnostic Systems Laboratories, Inc.1996-08-16
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 (K961281)Diagnostic Chemicals , Ltd.1996-08-16
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR (K962280)Roche Diagnostic Systems, Inc.1996-08-16
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY (K961837)Rusch Intl.1996-08-16
RADIAS PHENYLALANINE TEST (K960437)Bio-Rad1996-08-16
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (K962762)Biotraces, Inc.1996-08-16
BIOSCREW ABSORBABLE INTERFERENCE SCREW (K960940)Linvatec Corp.1996-08-15
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE (K961915)Respironics, Inc.1996-08-15
ARGON CURING LASER (K961682)Premier Laser Systems, Inc.1996-08-15
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER (K962215)U.S. Medical Products, Inc.1996-08-15
ACCESS (POWERCLAVE) (K954736)Mdt Biologic Co.1996-08-15
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET (K961912)Consolidated Technologies, Inc.1996-08-15
OPUS MYOGLOBIN CONTROLS (K962841)Behring Diagnostics, Inc.1996-08-15
ACA PLUS FREE THYROXINE(FT4) METHOD (K962602)Dade Intl., Inc.1996-08-15
HICHEM CK/NAC REAGENT KIT (K962247)Elan Pharma, Inc.1996-08-15
DINAMAP SELECT MULTI-PARAMETER SYSTEM (K955113)Johnson & Johnson Medical, Inc.1996-08-15
ACA PLUS FT4 CALIBRATOR (K962594)Dade Intl., Inc.1996-08-15
MOORE TRACHEOSTOMY TUBE (K962240)Boston Medical Products, Inc.1996-08-15
GRAYCO POCKET PUMP (K955507)Grayco, Inc.1996-08-15
PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE) (K962650)Sti Medical Sdn Bhd1996-08-15
NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY (K960584)Novavision, Inc.1996-08-15
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 (K962997)Nova Biomedical Corp.1996-08-15
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY (K962673)Princeton BioMeditech Corp.1996-08-15
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962344)Bayer Corp.1996-08-15
PLASTIC PROTECTION HEALING CAPS (K962023)The Straumann Co.1996-08-15
ELECSYS T3 (K962508)Boehringer Mannheim Corp.1996-08-15
BAXTER NEBULIZER CAP MODEL 2D0868 (K962161)Baxter Healthcare Corp1996-08-15
DHD ACE WITH MASK KIT (K961973)Dhd Diemolding Healthcare Div.1996-08-15
QUIX RAPID CHOLERA STRIP TEST (K954995)Guardian Scientific, Corp.1996-08-15
POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM (K960841)Boston Medical Corp.1996-08-15
ENDOCARE ELECTORNIC THERMOMETER SYSTEM (K961365)Endocare, Inc.1996-08-15
MODEL 2188 CORONARY SINUS LEAD. (K961936)Medtronic Vascular1996-08-15
ANDELA DYNAMIC COOLING DEVICE (K951033)Candela Laser Corp.1996-08-15
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY (K962669)Princeton BioMeditech Corp.1996-08-15
BERENSTEIN COIL (K961923)Target Therapeutics1996-08-15
SICKLE-2000 (K955719)Medicus Technologies, Inc.1996-08-14
GORE BURR HOLE COVER (K960656)W. L. Gore & Associates, Inc.1996-08-14
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM (K962152)Osteonics Corp.1996-08-14
BIPOLAR PENCIL COAGULATOR (K962678)Kirwan Surgical Products, Inc.1996-08-14
EAGLE EYES SUNGLASSES (K962287)Positive Response Television1996-08-14
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES (K962461)Shen Wei (Usa), Inc.1996-08-14
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS (K960474)Cobe Renal Care, Inc.1996-08-14
MDI TUTOR (K961894)Mdi Tutor, Inc.1996-08-14
BACTERIA/VIRAL FILTER (K961914)Hudson Respiratory Care, Inc.1996-08-14
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) (K962048)Hitachi Medical Systems America, Inc.1996-08-14
PROCAINAMIDE ENZYME IMMUNOASSAY (K962463)Diagnostic Reagents, Inc.1996-08-14
SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (K960871)Medical Diagnostic Technologies, Inc.1996-08-14
NHMC IRRIGATION TRAY (K962670)National Healthcare Mfg. Corp.1996-08-14
DURAFLOR (K961893)Pharmascience, Inc.1996-08-14
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) (K955931)Advanced Medical Systems, Inc.1996-08-14
DALL-MILES TROCHANTER CABLE SUPERGRIP (K962162)Howmedica Corp.1996-08-14
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (K962789)Smith & Nephew Endoscopy, Inc.1996-08-14
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR (K962476)Tambrands, Inc.1996-08-13
RMI HEMOCONCENTRACTOR TUBING SET (K961927)Research Medical, Inc.1996-08-13
S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) (K961939)Johnson & Johnson Professionals, Inc.1996-08-13
PEEP VALVE (K961867)Medical Marketing Concepts1996-08-13
THE AMPLATZ THROMBECTOMY DEVICE (K954205)Microvena Corp.1996-08-13
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT (K962082)Osteonics Corp.1996-08-13
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL (K952614)Dentsply Intl.1996-08-13
TRS 2000 TELERADIOLOGY SYSTEM (K961983)Sectra-Imtec AB1996-08-13
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (K961814)Cardiovascular Diagnostics, Inc.1996-08-13
MICROSELECTRON-HDR VERSION 2 (K953946)Nucletron-Oldelft Corp.1996-08-13
GLOVE, EXAMINATION, VINYL (K952050)Oak Carolina, Inc.1996-08-12
STOP-N-GROW (K960843)European Touch Co., Inc.1996-08-12
3M DENT SYSTEM (K962785)3M Company1996-08-12
D. DEVICE II (K955742)Yousef Daneshvar1996-08-12
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 (K961869)Sorin Biomedical, Inc.1996-08-12
DAVID BACK CLINIC SYSTEM (K952163)Kinetic Resources, Inc.1996-08-12
HYCOAT (K960686)The Hymed Group Corp.1996-08-12
EXTRAHAND BALLOON RETRACTOR (K962005)Origin Medsystems, Inc.1996-08-12
BRAINLAB HEADPINS (K954789)Brainlab AG1996-08-12
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT (K960749)International Technidyne Corp.1996-08-12
INPUT TUOHY-BORST LOCKING DEVICE (K960445)C.R. Bard, Inc.1996-08-12
HEAD RETAINING DEVICE (K961467)S. and H. Engineering, Inc.1996-08-09
OLYPUS FG SERIES GRASPING FORCEPS (K962533)Olympus America, Inc.1996-08-09
MT10P, MT60-PP, MT60-AGC0, AND MT60 (K962847)Micro-Tech Hearing Instruments1996-08-09
DEPUY DISPOSABLE FILTER/HOOD (K961791)Depuy, Inc.1996-08-09
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) (K962380)Olympus America, Inc.1996-08-09
SINGLE USE INSTRUMENT TRAY (K962328)Medcare Medical Group, Inc.1996-08-09
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Every clearance here is in the API, with alerts when new ones post.