Atlas FDA

1995

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

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RecordFirmDate
ETHICON ARTHROSCOPIC KNOT PUSHER (K952814)ETHICON, Inc.1995-07-11
HOLLISTER HYDROCOLLOID WOUND DRESSINGS (K950933)Hollister, Inc.1995-07-11
SWEDE-VENT IMPLANT (K950577)Core-Vent Corp.1995-07-11
CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS (K934628)Valleylab, Inc.1995-07-11
MICRO-VENT IMPLANT (K950579)Core-Vent Corp.1995-07-11
OGDEN ANCHOR (K950875)American Medical Electronics, Inc.1995-07-11
SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE (K951905)H.S. Intl. Co., Inc.1995-07-11
BIO-VENT IMPLANT (K950575)Core-Vent Corp.1995-07-11
DURACON RECESSED PATELLA (K951655)Howmedica Corp.1995-07-11
SCREW-VENT IMPLANT (K950578)Core-Vent Corp.1995-07-11
RIGHT-ON ADHESIVE BOUDING SYSTEM (K952643)Tp Orthodontics, Inc.1995-07-11
ANSPACH SUTURE ANCHOR (K945525)The Anspach Effort, Inc.1995-07-11
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN (K946274)Helena Laboratories1995-07-11
FOUNDATION POROUS STEM (K935263)Encore Orthopedics, Inc.1995-07-11
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (K951721)Applied Medical Resources1995-07-11
DIPLOMAX (K946054)Optical Micro Systems, Inc.1995-07-11
STERICARE WOUND CARE GEL (K951861)Acacia Laboratories, Inc.1995-07-11
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (K952689)Owens-Brigam Medical Co.1995-07-11
BUFFALO FILTER REPLACEMENT FILTER #BSPF030 (K943226)Buffalo Filter Co., Inc.1995-07-10
AUTO SYRINGE(R) AS50 INFUSION PUMP (K945942)Baxter Healthcare Corp1995-07-10
CAPCARD (K942930)Capcard, Inc.1995-07-10
DEPUY SET SCREW (K950833)Depuy, Inc.1995-07-10
WELCH ALLY OTOSCOPE (K952578)Welch Allyn, Inc.1995-07-10
DEVONS POINT LOK NEEDLE PROTECTION DEVICE (K946289)Devon Industries, Inc.1995-07-10
SHARPS AWAY (K943765)Biomedical Waste Systems, Inc.1995-07-10
URESIL(R) GUIDEWIRE (K945934)Uresil Corp.1995-07-10
COLD LIGHT SOURCE LOS 150 (K951829)Laser-Optik-Systeme GmbH & Co. KG1995-07-10
STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (K952678)Avail-Southwest Division1995-07-10
ECG ELECTRODE (K944260)Msb , Ltd.1995-07-07
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES) (K944451)Passy-Muir, Inc.1995-07-07
INTEGRATED MOVEMENT ANALYZER (K944787)Maryrose1995-07-07
OCR II & OCM II (K942989)Chambermaid Products Co.1995-07-07
MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS (K951812)Lumenis, Inc.1995-07-07
POLYGRAM SOFTWARE (K946322)Synectics Medical, Inc.1995-07-07
BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 (K943227)Buffalo Filter Co., Inc.1995-07-07
MEDI-TRACE(R) 500 ECG ELECTRODE (K945479)Graphic Controls Corp.1995-07-07
PRECISE DENTURE BASE RESIN (K952351)Dentsply Intl.1995-07-07
RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR (K944052)Ohmeda Medical1995-07-07
POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER (K952428)Porous Media Corp.1995-07-07
TICARCILLIN/CLAVULANIC ACID 2 (K951879)Ab Biodisk1995-07-07
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE (K950485)Graphic Controls Corp.1995-07-07
OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) (K951806)Opgal Optronic Industries1995-07-06
THORACENTESIS CATHETER (K951524)Baxter Healthcare Corp1995-07-06
MED-TEC REDI-FOAM (K951808)Medtec, Inc.1995-07-06
PROFIX CONFORMING PLUS TIBIAL INSERT (K946236)Smith & Nephew Richards, Inc.1995-07-06
CLEAR ADVANTAGE II (K945628)Mentor Corp.1995-07-06
PIPER, MODEL NUMBER UDS-PIPERB (K951805)Laborie Medical Technologies, Ltd.1995-07-06
AMS 650 MALLERABLE PENIEL PROSTHESIS (K951716)American Medical Systems, Inc.1995-07-06
GSI 65 COMPUTERIZED AUDIOMETER (K951759)Grason-Stadler, Inc.1995-07-06
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL (K952452)Argosy Electronics1995-07-06
CLASS D LINEAR WITH ACTIVE TONE CONTROL (K952451)Argosy Electronics1995-07-06
ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION (K952408)Pymah Corp.1995-07-06
MED-TRON SPECT IMAGING TABLE (K952701)Med-Tron Products, Inc.1995-07-06
QUICKIE TSR (K952641)Sunrise Medical, Inc.1995-07-06
3M MAXI-DRIVER II ELECTRIC SYSTEM (K951118)3M Company1995-07-06
INTROPORT(TM) CATHETER MODEL #1000(ICT) (K946189)Lifequest Medical, Inc.1995-07-06
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES (K951673)Acu Med, Inc.1995-07-06
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR (K952265)Control-X, Inc.1995-07-06
STAT PROFILE ULTRA BLOOD GAS CONTROLS (K952477)Nova Biomedical Corp.1995-07-06
THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D. (K952537)Therex Corp.1995-07-06
F-230 POROUS FEMORAL HIP STEM (CEMENTLESS) (K941612)Implex Corp.1995-07-06
THE HILL ADJUSTABLE PODIATRY MODEL (K952357)Hill Laboratories Co.1995-07-06
FIXATION PINS/WIRES (K943856)Acu Med, Inc.1995-07-06
STERILE EQUIPMENT COVERS (K931417)Custom Medical Products, Ltd.1995-07-06
T-350 THERAPEUTIC COOLING MACHINE (K950711)Thermotek, Inc.1995-07-06
HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY (K943494)Lyco Enterprises, Inc.1995-07-06
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL (K952450)Argosy Electronics1995-07-06
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) (K946380)American Hydro-Surgical Instruments, Inc.1995-07-06
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE (K952367)Cypress Medical Products, Ltd.1995-07-05
ORTHOPEDIC SCREW FIXATION (K932350)Osteomed Corp.1995-07-05
HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% (K952261)Pilkington Barnes-Hind, Ltd.1995-07-05
OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES (K952182)Immunotech, Inc.1995-07-05
ORTHOPEDIC BONE PLATE (K932352)Osteomed Corp.1995-07-05
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT (K952425)Olympus America, Inc.1995-07-05
BIPOLAR COAGULATION INSTRUMENT (K952161)Johnson & Johnson Professionals, Inc.1995-07-05
UBI MAGIWEL FERRITIN QUANTITATIVE (K951993)United Biotech, Inc.1995-07-05
LINK ENDO MODEL REVISION CUP (K943986)Turnkey Intergration USA, Inc.1995-07-05
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (K951533)Ballard Medical Products1995-07-05
LOCK-UP (K951736)Medline1995-07-05
SYMBIOSIS BIPOLAR FORCEPS (K952432)Symbiosis Corp.1995-07-05
GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE (K950489)Graphic Controls Corp.1995-07-03
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING (K952081)KARL STORZ Endoscopy-America, Inc.1995-07-03
V40 ZIRCONIA FEMORAL HEADS (K952418)Howmedica Corp.1995-07-03
PHILIPS EASYVISION (K952704)Philips Medical Systems, Inc.1995-07-03
PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR (K932922)Cottrell, Ltd.1995-07-03
LMT BONE ANCHOR (K951233)Li Medical Technologies, Inc.1995-07-03
PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (K945985)Burdick, Inc.1995-07-03
LORI-A (K952711)Lori Medical Laboratories, Inc.1995-07-03
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS (K951144)GE Medical Systems1995-07-03
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE (K950488)Graphic Controls Corp.1995-07-03
LMT BONE ANCHOR (K951472)Li Medical Technologies, Inc.1995-07-03
OGDEN ANCHOR (K951493)American Medical Electronics, Inc.1995-07-03
AMERLITE FSH ASSAY (K952285)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-03
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (K952505)Nichols Institute1995-07-03
ACUTEK'S CLEARPASSAGE (K951644)Acutek Adhesive Specialties, Inc.1995-07-03
SUCTION CATHETER KIT, STERILE, SINGLE-USE (K951506)Trinity Laboratories, Inc.1995-07-03
OPUS PROCAINAMIDE (K951434)Behring Diagnostics, Inc.1995-07-03
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K950816)Lifescan, Inc.1995-07-03
HARPOON SUTURE ANCHORS (K943806)Biomet, Inc.1995-07-03
RICHARDS TORP (K952549)Smith & Nephew Richards, Inc.1995-07-03
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Every clearance here is in the API, with alerts when new ones post.