Atlas FDA

1996

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

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RecordFirmDate
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS (K963963)Becton Dickinson Immunocytometry Systems1996-12-12
SHUNT TAP (K963802)Integra Neurocare, LLC1996-12-12
SUNGLASSES OR MULTIPLE (K964429)Trade Resources , Ltd.1996-12-12
LOVING SMARTER - SAFER SEX (K963679)Loving Smarter, Inc.1996-12-12
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM (K963669)Astro-Med, Inc.1996-12-12
BRENNEN MEDICAL GLUCAN II WOUND DRESSING (K964241)Brennen Medical, Inc.1996-12-12
EQUINOX DIGITAL EEG SYSTEM (K962447)Physiometrix, Inc.1996-12-12
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (K963839)Cordis Corp.1996-12-12
OLYMPUS MOBILE CHAIR/COUCH (K962528)Keymed (Medical & Industrial Equipment), Ltd.1996-12-12
INTRAVASCULAR INFUSION DEVICE (K963988)Boston Scientific Corp1996-12-12
BILIBED PHOTOTHERAPY LAMP (K962612)Medela, Inc.1996-12-12
RECOVER ADULT VEIN WARMER (K963689)Florida Medical Industries, Inc.1996-12-12
ULTRADENT UNIVERSAL DENTIN SEALANT (K963979)Ultradent Products, Inc.1996-12-12
REUSABLE TROCAR WITH SLEEVE (COMMON) (K964123)Pilling Weck Group1996-12-12
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID (K963746)Whitehill Oral Technologies, Inc.1996-12-12
COURIER BALLOON DILATATION CATHETER (K963691)Boston Scientific Corp1996-12-12
ULE-2, MULE-2, HAND ACCESSORY KIT (K962855)Penny and Giles Biometrics , Ltd.1996-12-11
OES UROLOGY (K950719)Olympus America, Inc.1996-12-11
700-F SERIES STIMULATION ELECTRODES (K964469)Cardiotronics Systems, Inc.1996-12-11
CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES (K963159)Cmc Sense-It, Inc.1996-12-11
LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 (K963924)Pari Holding Co.1996-12-10
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 (K961908)Helena Laboratories1996-12-10
KSEA THERMOCOAGULATOR (MODEL 265100 20) (K963852)KARL STORZ Endoscopy-America, Inc.1996-12-10
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS (K961223)Criticare Systems, Inc.1996-12-10
ACTIS (VENOUS FLOW CONTROLLER) (K962915)Vivus, Inc.1996-12-10
MAXISTIM (K955031)Life-Tech Intl., Inc.1996-12-10
EZ STIM (K954505)Life-Tech Intl., Inc.1996-12-10
ESORT II + 400 SERIES MONITOR (K961138)Medical Data Electronics1996-12-10
VERDICT PCP (K963692)Editek, Inc.1996-12-10
ARDENT FUTURA NON GAMMA-2 (K964775)Ardent Production Development1996-12-10
VITAJET (K962625)Vitajet Corp.1996-12-10
HAEMOCELL SYSTEM 350 OR S350 (K960734)Haemocell Plc1996-12-10
CEDIA DAU BENZODIAZEPINE ASSAY (K962734)Boehringer Mannheim Corp.1996-12-10
SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM (K960771)Rymed Technologies, Inc.1996-12-10
PORPHOBILINOGEN (PBG) (K961984)Trace America, Inc.1996-12-10
DIGOXIN ENZYME IMMUNOASSAY (K963835)Diagnostic Reagents, Inc.1996-12-10
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT (K962598)Nichols Institute Diagnostics1996-12-10
THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 (K954523)Thermoscan, Inc.1996-12-10
PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT (K963956)Southern Research, Inc.1996-12-09
TRANSFLOW TEST (K953990)P.K. Morgan , Ltd.1996-12-09
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (K962880)Sherwood Medical Co.1996-12-09
MEDICOTEST ECG ELECTRODES (K961643)Medicotest, Inc.1996-12-09
EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) (K964334)Shippert Medical Technologies Corp.1996-12-09
DMS-1000C DERMOABRADER (K965256)Mattioli Engineering, Srl1996-12-09
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS (K963796)Howmedica Corp.1996-12-09
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM (K961937)Delphi Consulting Group1996-12-09
ULTIMA FX FEMORAL HIP STEMS (K963885)Johnson & Johnson Professionals, Inc.1996-12-09
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM (K962314)Osteonics Corp.1996-12-09
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR (K962608)Synthes (Usa)1996-12-09
ACUMED TENSION BAND PIN (K964500)Acu Med, Inc.1996-12-09
DMS-1000C DERMOABRADER (K963204)Aesthetic Lasers, Inc.1996-12-09
ELLIS EXTERNAL MINI-FIXATOR SYSTEM (K964458)Link America, Inc.1996-12-09
ML MICROKERATOME BLADE (K962661)Med-Logics, Inc.1996-12-09
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER (K964216)Starkey Laboratories, Inc.1996-12-06
OZARK 46 (K964568)Gateway Alloys, Inc.1996-12-06
EL DORADO 75 (K964567)Gateway Alloys, Inc.1996-12-06
CLINICAL BLOOD GAS MIXTURES (K964475)Oxarc, Inc.1996-12-06
COUPLING DEVICE FOR DENTAL PROSTHESIS (K950259)Dr. Joseph E. Grasso, D.D.S.1996-12-06
PALLADIA 76 (K964572)Gateway Alloys, Inc.1996-12-06
VIRAPUMP II (MODELS AND MODEL M) (K961607)Viatro, Corp.1996-12-06
ALPHA-DENT ROOT CANAL SEALER & FILLER (K963922)Wallace A. Erickson & Co.1996-12-06
MANAN PROSTATE UNI-LOCK (K963743)Manan Medical Products, Inc.1996-12-06
AHS OMEGA HF (K963878)Authorized Hearing Systems, Inc.1996-12-06
AHS OMEGA CONCEPT (K963877)Authorized Hearing Systems, Inc.1996-12-06
PIEDMONT 70 (CH-35) (K964573)Gateway Alloys, Inc.1996-12-06
TRUBYTE SOFT RELINE SYSTEM (K964040)Dentsply Intl.1996-12-06
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK (K964421)Remel, L.P.1996-12-06
OZARK 20 (K964566)Gateway Alloys, Inc.1996-12-06
KSEA THERMOFLATOR (MODEL 26 4320 20) (K955073)KARL STORZ Endoscopy-America, Inc.1996-12-06
EL DORADO 58 (K964569)Gateway Alloys, Inc.1996-12-06
GALILEO HYSTEROSCOPES AND LAPAROSCOPES (K962256)Galileo Electro-Optics Corp.1996-12-06
PHILIPS SLI SERIES LINEAR ACCELERATOR (K963624)Philips Medical Systems, Inc.1996-12-06
MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA (K962969)Medical Device Technologies, Inc.1996-12-06
ARTICULAR HEARING AIDS (K964603)Decibel Instruments, Inc.1996-12-06
THE SAFETY 1ST DIGITAL PACIFIER (K963276)Safety 1st, Inc.1996-12-06
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS (K963770)Biocircuits Corp.1996-12-05
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (K935778)Via Medical Corp.1996-12-05
HEMAGEN ENA DSDNA KIT (EIA METHOD) (K962276)Hemagen Diagnostics, Inc.1996-12-05
HYPERBARIC CHAMBER (K960389)Tampa Hyperbaric Ent.1996-12-05
WHISPER SWIVEL II EXHALATION PORT (K962203)Respironics, Inc.1996-12-05
TENET TIBIAL FRACTURE SUPPORT (K964102)Tenet Medical Engineering1996-12-05
NOVAGEL SILICONE GEL SHEETING (K963128)Brennen Medical, Inc.1996-12-05
CD HORIZON SPINAL SYSTEM (K961633)Sofamor Danek USA,Inc.1996-12-05
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT (K962557)Smith & Nephew Richards, Inc.1996-12-05
GISH RELIANCE OXYGENATOR (MODEL HFO) (K961530)Gish Biomedical, Inc.1996-12-05
VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES (K964175)Valleylab, Inc.1996-12-05
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT (K963958)Beltone Electronics Corp.1996-12-05
HUMERUS WIRES (K964243)Compagnie Financiere & Medicale (Cf&M)1996-12-05
AMS AMBICOR PENILE PROSTHESIS (K963328)American Medical Systems, Inc.1996-12-04
FOOT WEIGHT ALARM (K962591)Cleveland Medical Devices, Inc.1996-12-04
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR (K963558)Contemporary Products, Inc.1996-12-04
SOFT DENTURE REBASING RESIN (K963736)Sybron Dental Specialties, Inc.1996-12-04
STETHOS (K963621)Theratechnologies, Inc.1996-12-04
XH-1 NEUROMUSCULAR STIMULATOR (K950550)California Medical Research Institute1996-12-04
SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE (K952315)Emg Scientific1996-12-04
DE ORO 77 (K964476)Gateway Alloys, Inc.1996-12-04
POLAR CARE 300 (K963596)Breg, Inc.1996-12-04
EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST (K963231)Excel Scientific, Inc.1996-12-04
CEMENT-ON FEMORAL STEM (K963709)Biomet, Inc.1996-12-04
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (K963811)Card Guard Scientific Survival , Ltd.1996-12-04
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Every clearance here is in the API, with alerts when new ones post.