Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ARTERIAL EMBOLECTOMY (K935405)J-Lloyd Medical, Inc.1994-07-25
TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE (K941944)Tahoe Surgical Instruments P.R., Inc.1994-07-25
OPTICOM M600 (K932258)Clement Clarke, Inc.1994-07-25
LIFE PULSE RESUSCITATION TIMER (K932867)Green Field Medical Sourcing, Inc.1994-07-25
PHACO KIT (K942515)Surgin Surgical Instrumentation, Inc.1994-07-25
INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. (K922872)Interpore Intl.1994-07-25
SUNGLASSES (K941874)The Fair Optical Ent.Co. , Ltd.1994-07-25
POS-T-VAC-AVP-1000 (K941087)Pos-T-Vac, Inc.1994-07-25
SUNGLASSES, SPECTACLE FRAMES (K940372)Giorgio Nannini Srl1994-07-25
SPECTACLE FRAMES (K942750)Aspex Eyewear, Inc.1994-07-25
NIL (K942755)Ever Great International , Ltd.1994-07-25
AUTO SUTURE PITUITARY SPINAL RONGEUR (K943115)United States Surgical, A Division of Tyco Healthc1994-07-25
NON-PRESCRIPTION SUNGLASSES (K942673)Angel Eyewear1994-07-25
ORVIS WORLD FINEST POLARIZED CLIP ONS (K942952)The Orvis Co., Inc.1994-07-25
SUNGLASSES (K942037)Golden Year Supply Co.1994-07-25
ECLIPSE 3200 (K943311)Cardiogenes1994-07-22
MITEK GIII ANCHOR (K931782)Mitek Surgical Products, Inc.1994-07-22
ARGESOL #585 (K942981)Argen Precious Metals, Inc.1994-07-22
ARGESOL 750W (K943087)Argen Precious Metals, Inc.1994-07-22
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (K923335)Advanced Medical Systems, Inc.1994-07-22
ORTHOCENT: LIQUID AND POWDER (K942665)Dentauraum, Inc.1994-07-22
REUSABLE PROBES (K943070)Surgin Surgical Instrumentation, Inc.1994-07-22
VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A (K930835)Ivoclar North America, Inc.1994-07-22
ARGESOL LO (K942929)Argen Precious Metals, Inc.1994-07-22
ARGESOL-ARGICRAFT-1 (K942979)Argen Precious Metals, Inc.1994-07-22
UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED (K934729)Implantology Corp.1994-07-22
INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS (K940718)Innervision, Inc.1994-07-22
EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET (K941731)Incutech, Inc.1994-07-22
ARGEDENT 41 (K943037)Argen Precious Metals, Inc.1994-07-22
SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM (K941554)Lifecore Biomedical, Inc.1994-07-22
TEMPOARY POLYCARBONATE CROWNS (K932759)South American Dental Exporting Corp.1994-07-22
ETEX HA HIP REPLACEMENT SYSTEM (K935696)Etex Corp.1994-07-22
O-TRAY IMPRESSION TRAYS (K942668)Dentauraum, Inc.1994-07-22
FOUNDATION METAL-BACKED PATELLA (K932246)Encore Orthopedics, Inc.1994-07-22
ODYSSEY TAN 2000 (K936314)Fitness TO Go, Inc.1994-07-22
ARGESOL-NOVASOL (K942943)Argen Precious Metals, Inc.1994-07-22
FOUNDATION MODULAR TIBIAL BASEPLATE (K932425)Encore Orthopedics, Inc.1994-07-22
AURIUM Y+ (K943032)Argen Precious Metals, Inc.1994-07-22
ARGESOL #615 (K942980)Argen Precious Metals, Inc.1994-07-22
ARGESOL #650 (K942978)Argen Precious Metals, Inc.1994-07-22
ARGESOL 830W (K943089)Argen Precious Metals, Inc.1994-07-22
BRAINLAB LINAC HARDWARE (K934657)Brainlab Med. Computersysteme GmbH1994-07-22
ARGESOL R (K943088)Argen Precious Metals, Inc.1994-07-22
ANGLED DISSECTORS MODELS 8383.581/582/571 (K940948)Richard Wolf Medical Instruments Corp.1994-07-21
SYRINGE (K942615)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-07-21
MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES (K936249)Medicon Instruments, Inc.1994-07-21
MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (K942747)Engineered Orthopedic Technologies, Inc.1994-07-21
IOI COCR UNIPOLAR PROSTHESIS (K934159)Intermedics Orthopedics1994-07-21
ARGESOL 500 (K942928)Argen Precious Metals, Inc.1994-07-21
AESCULAP FLEXIBLE TROCAR INSTRUMENT SET (K935243)Aesculap, Inc.1994-07-21
ARGESOL-YPF (K942859)Argen Precious Metals, Inc.1994-07-21
GEENEN/ZEBRA GUIDELINES (K942677)Boston Scientific Corp1994-07-21
AMERICAN CATHETER POLY-SNARE (K940335)Intl. Medical, Inc.1994-07-21
ACUFEX ENDOBUTTON SYSTEM (K933948)Acufex Microsurgical, Inc.1994-07-21
MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES (K936246)Medicon Instruments, Inc.1994-07-21
STIMULATING SURGICAL INSTRUMENTS (K934733)Smith & Nephew Richards, Inc.1994-07-20
UNICATH FAMILY (K942503)Angiographic Devices Corp.1994-07-20
PHANTOM (K941363)Dynarad Corp.1994-07-20
HAE 1 (K942829)Hearing Aid Express1994-07-20
AUTO SUTURE SPINAL DISSECTOR (K942971)United States Surgical, A Division of Tyco Healthc1994-07-20
VIDEO ENDOSCOPE-RIGID MODIFICATION (K921294)Medical Dynamics, Inc.1994-07-20
OPUS PROCAINAMIDE TEST SYSTEM (K934762)Pb Diagnostic Systems, Inc.1994-07-20
KIT PAK DRESSING CHANGE TRAY (K941499)Kit Pak, Inc.1994-07-20
CONMED ANDOVER MED ECG ELECTRODES (K942925)Conmed Andover Medical, Inc.1994-07-20
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (K942774)The Kendal Co.1994-07-20
HYDROTORQUE GUIDE WIRE (K935232)Kingston Technologies, Inc.1994-07-20
HAE 3 (K942830)Hearing Aid Express1994-07-20
AURIS CIC (K943144)General Hearing Instruments, Inc.1994-07-20
AUTO SUTURE SPINAL CURETTE (K942967)United States Surgical, A Division of Tyco Healthc1994-07-20
DNA TRIGLYCERIDE PROCEDURE (K941063)Data Medical Associates, Inc.1994-07-20
AUTO SUTURE SPINAL ELEVATOR (K942970)United States Surgical, A Division of Tyco Healthc1994-07-20
ACS CARDIO-TROL CONTROL (K941115)Analytical Control Systems, Inc.1994-07-20
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) (K942264)Eigen Video1994-07-20
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (K935984)Sigma Diagnostics, Inc.1994-07-20
COSMET (K933465)Great Bay Medical Products, Inc.1994-07-20
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 (K940433)Medical Analysis Systems, Inc.1994-07-20
AUTO SUTURE SPINAL OSTEOTOME (K942968)United States Surgical, A Division of Tyco Healthc1994-07-20
TECNADYNE T-CUFF (K942303)Technadyne Scientific, Inc.1994-07-20
THERMOSCAN INSTANT THERMOMETER IR-5000 (K930680)Thermoscan, Inc.1994-07-20
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 (K941921)Medtronic Bio-Medicus, Inc.1994-07-20
CEDIA DAU AMPHETAMINES ASSAY (K941372)Microgenics Corp.1994-07-20
CORDIS GRAVITY COMPENSATING ACCESSORY (K932429)Cordis Corp.1994-07-20
HAE 2 (K942831)Hearing Aid Express1994-07-20
CRONEX REGULAR CASSETTE (K941475)Dupont Medical Products1994-07-20
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (K941662)Gm Engineering, Inc.1994-07-20
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED (K941981)W. L. Gore & Associates, Inc.1994-07-20
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE (K941221)Dupont Medical Products1994-07-20
CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT (K936313)Prevention Sciences1994-07-20
STANBIO ALT/GPT (LUQUI-UV) TEST SET (K941314)Stanbio Laboratory1994-07-20
WALLACH LEEP PROCEDURE KIT (K935634)Wallach Surgical Devices, Inc.1994-07-20
AUTO SUTURE SPINAL NERVE HOOK (K942969)United States Surgical, A Division of Tyco Healthc1994-07-20
SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP (K941984)Sabratek Corp.1994-07-19
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K936016)R&D Systems, Inc.1994-07-19
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS (K940971)Heraeus Kulzer, Inc.1994-07-19
CLAMPS AND CLIPS (K942896)Surgin Surgical Instrumentation, Inc.1994-07-19
STB YANKAUER SUCKER/NOZZLE (K933762)Save-T-Breath Distributors C.C.1994-07-19
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH (K942879)Deroyal Industries, Inc.1994-07-19
VITALMAX 530 (K932203)Pace Tech Medical Monitors, Inc.1994-07-19
VITALMAX 4000 (K933624)Pace Tech, Inc.1994-07-19
SIMPULSE SOLO SUCTION IRRIGATOR (K942886)Davol Inc., Sub. C. R. Bard, Inc.1994-07-19
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Every clearance here is in the API, with alerts when new ones post.