Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CYLINDER IMPLANTS HA, TP, GRADE 3 (K953236)The Implant Center of the Palm Beaches1995-09-13
KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER (K951807)Kodak Health Imaging Systems, Inc.1995-09-13
LOW PROFILE TITANIUM MODEL CATALOG #1003 (K953110)Therex Corp.1995-09-13
DYNATRON 650 (K950348)Dynatronics Corp.1995-09-13
PRIME CEMENTED SMALL FEMORAL STEM (K953033)Orthopaedic Innovations, Inc.1995-09-13
KODAK XLS 8600 (PS) (K951948)Kodak Health Imaging Systems, Inc.1995-09-13
SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 (K953235)The Implant Center of the Palm Beaches1995-09-13
PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500) (K952610)Plexus Medical1995-09-13
DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM (K950479)Nikomed U.S.A., Inc.1995-09-13
CONVEEN LEG BAG STRAP (K953783)Coloplast Corp.1995-09-13
DYNATRON 950 (K950349)Dynatronics Corp.1995-09-13
KIS-- FOUR HOLE CYLINDER (K953139)Implant Center of the Palm Beaches1995-09-13
DILATATION CATHETER, BALLOON (K953004)Boston Scientific Corp1995-09-13
INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS (K945498)Instent, Inc.1995-09-12
YEOU NAN SUNGLASSES FRAME MFG, CO., LTD. (K954075)Yo Nan Sunglasses Co., Ltd.1995-09-12
HEARING AID (ALL-IN-THE-EAR) (K951712)Omega Hearing Aid Center1995-09-12
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE (K954155)Promex, Inc.1995-09-12
MEROCEL VAGINAL PACK (K953072)Merocel Corp.1995-09-12
CADWELL EASY AMBULATORY EEG (K946094)Cadwell Laboratories, Inc.1995-09-12
OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES (K945265)Optus, Inc.1995-09-12
MASTER-NEB NEBULIZER COMPRESSOR SYSTEM (K943717)Howard K. Mann & Assoc.1995-09-12
MEDELA'S FOOT PUMP (K952034)Medela, Inc.1995-09-12
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN (K953528)Roche Diagnostic Systems, Inc.1995-09-12
SUNGLASSES (K953947)Wenzhou Yian Optical International, Co., Ltd.1995-09-12
POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (K940026)Light Diagnostics1995-09-12
REVERT SUNGLASSES & POLAR SUNGLASSES (K953920)Bella Occhiali, Inc.1995-09-12
BAIR HUGGER MODEL 655 BLANKET (K952864)Augustine Medical, Inc.1995-09-12
EVOLUTION MICROCATHETER (K953114)Boston Scientific Corp1995-09-12
ARTICULATING RETRACTOR TISSUE RETRACTORS (K953348)Gm Engineering, Inc.1995-09-12
SOLARIX FV (K953832)GE Medical Systems1995-09-12
ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (K940027)Chemicon Intl., Inc.1995-09-12
HEARING AID (ALL-IN-THE-EAR) (K953960)Audina Hearing Instrument1995-09-12
SUNGLASSES (K953989)Morris & Sons Co.1995-09-12
NIL (K953782)Dehang Industries, Ltd.1995-09-12
SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) (K952438)Taiwan Eva Industrial Co., Inc.1995-09-12
LIGHT-CURE PC (K952856)Midwest Orthodontic Mfg.1995-09-12
DATACELL 18MS (K945678)Danam Electronics1995-09-12
SUNGLASSES & SPORT SUNGLASSES (K952963)Wenzhou Winsor Optical International Co., Ltd.1995-09-12
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K953918)Hitachi Medical Systems America, Inc.1995-09-12
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW (K952597)Point of View Optical Outlet, Inc.1995-09-12
ENTEROVIRUS 71 MONOCLONAL ANTIBODY (K940473)Chemicon Intl., Inc.1995-09-12
POLIOVIRUS 2 MONOCLONAL ANTIBODY (K940034)Light Diagnostics1995-09-12
ACCESS POINT (K953376)Access Surgical Intl., Inc.1995-09-12
K AMP FULL SHELL AND IN THE EAR (K953729)Midwest City Hearing Aid Center1995-09-12
RX12 LINEAR FULL SHELL AND IN THE CANAL (K953728)Midwest City Hearing Aid Center1995-09-12
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM (K952697)Smith & Nephew Richards, Inc.1995-09-12
POLIOVIRUS 3 MONOCLONAL ANTIBODY (K940017)Light Diagnostics1995-09-12
TYMPASNOSTOMY TUBE (K953993)Hampton Precision Products, Inc.1995-09-12
THE TULIP MONO-POLAR CAUTERY SPATULA (K952973)The Tulip Mfg. Co.1995-09-11
DEUCE (K943244)Apt Technology, Inc.1995-09-11
FASCIA CLOSURE DEVICE (K954011)KARL STORZ Endoscopy-America, Inc.1995-09-11
PTT 6200 ELEVATION THERAPY TABLE (K953622)U.S. Table, Inc.1995-09-11
STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW (K953369)Advanced Spine Fixation Systems, Inc.1995-09-08
N 800 HF (K953831)Nucletron-Oldelft Corp.1995-09-08
TMR48 (K953342)Pride Health Care, Inc.1995-09-08
PRESSURE SENSING SCOPE SHEATH SYSTEM (K944553)Linvatec Corp.1995-09-08
ANALGRAPH (K941801)Sandhill Scientific, Inc.1995-09-08
EXUSORB STERILE ABSORBENT (K953131)O.R. Resources, Inc.1995-09-08
COMBINATION KIT (K953331)Steri-Oss, Inc.1995-09-08
UROVISION JANUS (K953353)Life-Tech Intl., Inc.1995-09-08
INNOVASIVE DEVICES ROTATOR CUFF FASTENER (K951565)Innovasive Devices, Inc.1995-09-08
QUIK-STITCH (K953123)Coral Medical, Inc.1995-09-08
GAMBRO LUNDIA 94-500 DIALYZER (K945746)Cobe Renal Care, Inc.1995-09-08
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (K936254)Light Diagnostics1995-09-08
REDDY ILLUMINATOR (K950960)Luxtec Corp.1995-09-08
OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (K953498)Immunotech, Inc.1995-09-08
DOSI-FLOW, MODELS 20 & 30 (K952810)Leventon, S.A.1995-09-08
COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY (K936251)Light Diagnostics1995-09-08
UNI-SITE (K953018)Ttl Medical1995-09-08
ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS (K936073)Chemicon Intl., Inc.1995-09-08
LOW PROFILE TITANIUM MODEL CATALOG #1003 (K953017)Therex Corp.1995-09-08
ADP REAGENT, MODIFIED (K952252)Helena Laboratories1995-09-08
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES (K951595)Roche Diagnostic Systems, Inc.1995-09-08
IMMULITE HCG HIGH LEVEL CONTROL MODULE (K952251)Diagnostic Products Corp.1995-09-08
GENESIS CONSTRAINED SYSTEM (GCS) (K952271)Smith & Nephew Richards, Inc.1995-09-08
WAKO AUTOKIT APO A1 (K952615)Wako Chemicals USA, Inc.1995-09-08
COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES (K940471)Chemicon Intl., Inc.1995-09-08
DISPOSABLE BIOPSY FORCEP (K952630)Neuro Navigational Corp.1995-09-08
NG SECURE (K953375)M.C. Johnson Co., Inc.1995-09-08
NEXFLEX TOTAL HIP SYSTEM (K952629)Nexmed, Inc.1995-09-08
SLT 28MM XXL FEMORAL HEAD (K953025)Wrightmedicaltechnologyinc1995-09-08
LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE (K951990)Schoelly Technologies, Inc.1995-09-08
PC-LOCK (K952855)Midwest Orthodontic Mfg.1995-09-08
OSTEONICS SPINAL SYSTEM (K951725)Osteonics Corp.1995-09-08
ULTRACID F DISINFECTING SOLUTION (K953168)Ultradent Products, Inc.1995-09-08
WOUNDFOAM 4 X 4 (K953070)Trinity Laboratories, Inc.1995-09-08
DENTRAY II PLUS TRAY ADHESIVE (K952930)Confi-Dental Products Co.1995-09-08
DISPOSABLE TOOTHED GRASPING FORCEP (K952639)Neuro Navigational Corp.1995-09-08
ZETAPLUS (PUTTY) (K935890)Zhermack Dental Production1995-09-08
ULTRACID DISINFECTING SOLOUTION (K953167)Ultradent Products, Inc.1995-09-08
URESIL INTRODUCING NEEDLE (K953923)Uresil Corp.1995-09-08
COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY (K936089)Chemicon Intl., Inc.1995-09-08
COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY (K936252)Light Diagnostics1995-09-08
GAMBRO LUNDIA 94-600 DIALYZER (K945747)Cobe Renal Care, Inc.1995-09-08
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) (K951256)Target Therapeutics1995-09-08
HOFFMANN II EXTERNAL FIXATION SYSTEM (K952730)Howmedica Corp.1995-09-08
INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS (K924387)Instent, Inc.1995-09-08
BIOPSY NEEDLE (K953880)Biopsys Medical, Inc.1995-09-08
POLIOVIRUS 1 MONOCLONAL ANTIBODY (K940018)Light Diagnostics1995-09-08
ENTEROVIRUS 70 MONCLONAL ANTIBODY (K940363)Light Diagnostics1995-09-08
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Track 1995 automatically

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