Atlas FDA

2001

3,494 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DIMENSION PSA FLEX REAGENT CARTRIDGE (K003963)Dade Behring, Inc.2001-02-28
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP (K010444)C.R. Bard, Inc.2001-02-28
FLUOROPERM 151-OK, PARAGON HDS 100-OK (K010109)Paragon Vision Sciences2001-02-28
MODEL THERMO TEK QUICKCARE (K010502)Saat , Ltd.2001-02-27
DUO-DENT DENTAL IMPLANT (K010386)Duo-Dent Dental Implant Systems, LLC2001-02-27
ENGPLUS (K010059)Western Systems Research, Inc.2001-02-27
DIAMOND ALOE VERA, STERILE (K002666)Medi-Tech Intl. Corp.2001-02-27
MEDIVISION IGS SYSTEM (K003699)Medivision (U.S.A.), Inc.2001-02-27
SMF RESORBABLE MESHES AND SHEETS (K003786)Synthes (Usa)2001-02-27
OLYMPUS ENDOSCOPIC LIGATION DEVICE (K001744)Olympus America, Inc.2001-02-27
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL (K003946)GE Medical Systems2001-02-27
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS (K003868)Trek Diagnostic Systems, Inc.2001-02-27
PALFIQUE ESTELITE LV CLEAR (K010267)Tokuyama America, Inc.2001-02-27
PARE ENDOSCOPIC SUTURING SYSTEM (K003102)Pare Surgical, Inc.2001-02-27
ORTHOPILOT (K003347)Kinamed, Inc.2001-02-23
TRITON HIP SYSTEM (K003649)Hayes Medical, Inc.2001-02-23
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS (K003834)Trek Diagnostic Systems, Inc.2001-02-23
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN (K003749)Banta Healthcare2001-02-23
MAEDA NEW NEEDLE DISPOSABLE (K000581)Maeda Toyokichi Shoten2001-02-23
FREEDLAND TENSION SYSTEM (K003648)Etzem Technologies, Inc.2001-02-23
FADASSI MEDICAL FM-1 NO BLENDER (K003665)Fadasis Medical, Inc.2001-02-23
PERCUSSIVENEB, MODEL PN-2001 (K003684)Vortran Medical Technology 1, Inc.2001-02-23
MICROTARGETING DRIVE SYSTEM (K003776)FHC, Inc.2001-02-23
ENA SCREEN EIA KIT (K010148)The Binding Site, Ltd.2001-02-23
CD HORIZON SPINAL SYSTEM (K010249)Medtronic Sofamor Danek, Inc.2001-02-23
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S (K010021)Medical Components, Inc.2001-02-23
STERILE POWDERED LATEX SURGEON GLOVES (K010198)Supermax Glove Manufacturing Sdn Bhd2001-02-23
EASE-A-CULT (K002756)Diagnostica, Inc.2001-02-23
TAUT-INSUFFLATION NEEDLE (K003703)Taut, Inc.2001-02-22
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 (K003260)Metron Medical Australia, Pty, Ltd.2001-02-22
MEDLOGICS ML 4000, MODEL 4000 (K002515)Med-Logics, Inc.2001-02-22
CORTEX METAMAX (K001631)Cortex Biophysik GmbH2001-02-22
MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 (K003629)Terray Corp.2001-02-22
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE (K003672)Medge Platforms, Inc.2001-02-22
ELECTRICATOR MODEL 26000 (K010025)Dermatologic Lab & Supply, Inc.2001-02-22
HRH-127 HEAD ARRAY COIL (K010140)Mri Devices Corp.2001-02-22
URETEROSCOPES (K003806)Global Endoscopy, Inc.2001-02-22
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 (K003423)St. Francis Medical Equipment Co., Ltd.2001-02-22
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 (K010214)Survivalink Corp.2001-02-22
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A (K002758)Agilent Technologies Deutschland GmbH2001-02-22
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP (K010007)Taut, Inc.2001-02-22
Z-TOUCH (K003268)Brainlab AG2001-02-22
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES (K003914)Medtronic PS Medical2001-02-22
MINIENDO III (K003640)Sybron Dental Specialties, Inc.2001-02-22
VISULAS YAG II (K003885)Carl Zeiss, Inc.2001-02-22
MULTI-FUNCTION DEFIBRILLATION ELECTRODE (K002079)Medicotest A/S2001-02-22
CYSTOSCOPES (K003807)Global Endoscopy, Inc.2001-02-22
SUTUREGROOVE WEIGHT SIZING SET (K003646)Iop, Inc.2001-02-22
MEDRELIEF (K003507)Healthonics, Inc.2001-02-21
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES (K010228)W. L. Gore & Associates, Inc.2001-02-21
NUCAMMA BI90 (K003882)Is2 Research, Inc.2001-02-21
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT (K004000)Ocu-Ease Optical Products, Inc.2001-02-21
AURORA (K003651)Aurora Imaging Technology, Inc.2001-02-21
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K003252)Allergan, Inc.2001-02-21
PHOSPHORUS REAGENT (K003912)Jas Diagnostics, Inc.2001-02-21
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR (K003996)Ocu-Ease Optical Products, Inc.2001-02-21
ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING (K002896)The Westaim Corp.2001-02-21
EZ-HCG URINE(PREGNANCY TEST) (K003856)Biomerica, Inc.2001-02-21
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (K010374)Sonosite,Inc.2001-02-21
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 (K002912)Sterinc2001-02-21
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 (K010210)Curon Medical, Inc.2001-02-21
STRYKER HEATED INSUFFLATOR TUBE SET (K003792)Stryker Corp.2001-02-21
MEDITHERM MED2000 (K003332)Meditherm, Inc.2001-02-21
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT (K003789)Specialty Ultravision, Inc.2001-02-21
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE (K001852)Itamar Medical (C.M.) 1997 , Ltd.2001-02-21
CHALLENGER DIRECT COMPOSITE (K010219)International Dental Research2001-02-21
TE ME NA EPIDURAL CATHETER (K991259)Te ME NA S.A.R.L.2001-02-21
MICROSPEED EC MOTORSYSTEM GD650/GD653 (K003612)Aesculap, Inc.2001-02-20
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (K003608)Aesculap, Inc.2001-02-20
THROMBOREL S (K003870)Dade Behring, Inc.2001-02-20
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 (K010208)Dade Behring, Inc.2001-02-20
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 (K003470)Tuttnauer Co. , Ltd.2001-02-20
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 (K003659)Bionx Implants, Inc.2001-02-20
SYNTHES HAMSTRING LOOP (K003700)Synthes (Usa)2001-02-20
TOTAL BILIRUBIN REAGENT (K003892)Intersect Systems, Inc.2001-02-20
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 (K002054)Appriva Medical, Inc.2001-02-16
REGUTHERM 952 THERMOGRAPHIC SYSTEM (K003130)Sie-Med, Inc.2001-02-16
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 (K002650)Bentec Medical, Inc.2001-02-16
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (DEN000008)Life Technologies, Inc.2001-02-16
ADVANTAGE WINDOWS CT/PET FUSION (K010336)Ge Medical Systems, Inc.2001-02-16
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (K003933)Polymer Technology2001-02-16
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K002045)Total Water Treatment Systems, Inc.2001-02-16
ACTICOAT COMPOSITE DRESSING (K002466)Westaim Biomedical, Inc.2001-02-16
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4 (K010135)Invacare Corp.2001-02-16
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY (K003932)Polymer Technology2001-02-16
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES (K003755)Medline Industries, Inc.2001-02-16
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX (K001916)Novartis Nutrition Corp.2001-02-16
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) (K010297)Maxxim Medical2001-02-16
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS (K003549)Codman & Shurtleff, Inc.2001-02-15
PERFECTA AND EXTEND (K004032)Wrightmedicaltechnologyinc2001-02-15
COMFOR-CLINER (K010194)Recliner Care, Inc.2001-02-15
ONYX-RAD TELEMEDICINE PACS (K003607)Viztek, Inc.2001-02-15
PARIETEX COMPOSITE (PCO) MESH (K002699)Medical Device Consultants, Inc.2001-02-15
PERMLASTIC 3 (K003650)Sybron Dental Specialties, Inc.2001-02-15
DURABOND NON-PRECIOUS CERAMIC ALLOY (K010069)Matech, Inc.2001-02-15
ENHANCED POLYETHYLENE KNEE PROSTHESES (K001147)Howmedica Osteonics Corp.2001-02-15
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES (K010211)Allegiance Healthcare Corp.2001-02-15
TRI-FIT FEMORAL STEM (K010243)Corin USA2001-02-15
MITEK 2GII MENISCAL REPAIR SYSTEM (K002406)Mitek Products2001-02-15
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 (K002596)Gebauer Co.2001-02-15
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Every clearance here is in the API, with alerts when new ones post.