Atlas FDA

1995

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

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RecordFirmDate
DYNAPULSE 5000A (DP5000A) (K945111)Pulse Metric, Inc.1995-06-23
ULTRACISION HARMONIC SCAPEL (K952726)Ultracision, Inc.1995-06-23
CITATION DELTA SCOPE (K945390)Citation Medical Corp.1995-06-23
VINYL POWDER-FREE EXAMINATION GLOVES (K946021)Wilson Glove Products Co., Ltd.1995-06-23
PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER (K952414)Acacia Laboratories, Inc.1995-06-23
STERI-OSS SELF TAPING IMPLANT (K952644)Steri-Oss, Inc.1995-06-23
IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (K946247)Nichols Institute1995-06-23
TROJAN POLYURETHANE CONDOM (K942697)Carter Products1995-06-22
FLUORECORD MODEL 762 (K952493)Syracuse Scientific, Inc.1995-06-22
LESINSKI SURGICAL EAR DRESSING (K950906)Microtek Medical, Inc.1995-06-22
FILTRYZER (K942681)Toray Industries (America), Inc.1995-06-22
ISOLA SPINE SYSTEM (K944737)Acromed Corp.1995-06-22
LMD GIARDIA ANTIGEN DETECTION ASSAY (K944871)Lmd Laboratories1995-06-22
WEBB-MORLEY SPINE SYSTEM (K945781)Electro-Biology, Inc.1995-06-22
EVT-5000BX (K952600)U.S. Table, Inc.1995-06-22
THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE (K952358)Hill Laboratories Co.1995-06-22
THE HILL ADJUSTABLE COUNTERSTRAIN TABLE (K952356)Hill Laboratories Co.1995-06-22
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW (K945687)Smith and Nephew Donjoy, Inc.1995-06-22
LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW (K951415)Howmedica Corp.1995-06-22
SPECTRUM (K952431)Freedom Designs, Inc.1995-06-22
MECHANICAL WHEELCHAIR (K952069)Grand Seating King Corp.1995-06-22
SCIMED EXPO ANGIOGRAPHIC CATHETER (K951720)Scimed Life Systems, Inc.1995-06-22
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES (K951307)Baxter Healthcare Corp1995-06-22
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM (K951508)Boston Scientific Corp1995-06-22
THE HILL ADJUSTABLE HA90C (K952359)Hill Laboratories Co.1995-06-22
BRAUN PTA BALLOON CATHETER (K951248)B.Braun Medical, Inc.1995-06-22
TONGUE CLEAN (K952446)1-800-Tongues, Inc.1995-06-22
COMPSEAL (K952500)Jeneric/Pentron, Inc.1995-06-22
J & S WHEELCHAIRS MODELS 500, 500B, 502, 503, 504 AND 500T (K951621)J&S Associates1995-06-22
TITANIUM MANDIBULAR FRACTURE SYSTEM (K952168)Medicon, Inc.1995-06-22
CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 (K952423)Rolence Enterprise Co. , Ltd.1995-06-22
CARDON PHYSICAL THERAPY TABLE MODEL:R40194 (K951955)Cardon Rehabilitation Products, Inc.1995-06-22
OVAMED FALLOPIAN OSTIAL ACCESS CATHETER (K931167)Ovamed Corp.1995-06-22
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION (K950697)Depuy Motech1995-06-22
SUREFLEX FILES (K951607)Dentsply Intl.1995-06-22
SURVIVAL KIT (K950357)Opportunity Resources, Inc.1995-06-22
MODEL #801GE1500 PEDIATRIC ARRAY COIL (K951649)Medic, Inc.1995-06-22
DYNATRON 250 (K944935)Dynatronics Corp.1995-06-22
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM (K943933)Aladan Corp.1995-06-22
ULTEC THIN HYDROCOLLOID DRESSING (K952071)Sherwood Medical Co.1995-06-22
3M RESIN CEMENT (K952121)3M Medical Products Group1995-06-22
VS11 SF (K951271)Metalor Dental USA Corp.1995-06-22
TORQUE LIMITER (K952120)Steri-Oss, Inc.1995-06-22
THE HILL ADJUSTABLE 90MD (K952355)Hill Laboratories Co.1995-06-22
SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE (K950216)Scimed Life Systems, Inc.1995-06-22
GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET (K952543)Neoligaments, Ltd.1995-06-22
MEDI-TRAC EEG ELECTRODE (K950782)Graphic Controls Corp.1995-06-22
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS (K950652)Osteotech, Inc.1995-06-22
BACKCYCLER CPM(TM) (K945690)Ergomedics, Inc.1995-06-22
THE HILL ADJUSTABLE RATH MECHANICAL TABLE (K942109)Hill Laboratories Co.1995-06-22
MITRAFLEX WOUND DRESSING WET-STICK (K952217)Polymedica Industries, Inc.1995-06-22
THE HILL ADJUSTABLE EXTEND-R TABLE (K942256)Hill Laboratories Co.1995-06-22
COWBOY X (K944567)Kinetic Concepts, Inc.1995-06-21
IMPROVED MANHATTAN II (K952455)Argosy Electronics1995-06-21
ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS (K951546)Ethicon Endo-Surgery, Inc.1995-06-21
GRAHAM-FIELD ULTRASOUND SCANNING GEL (K944597)Chester Labs, Inc.1995-06-21
INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL (K952453)Argosy Electronics1995-06-21
EBI SMALL EXTERNAL FIXATOR (S/E/F/) (K951357)Electro-Biology, Inc.1995-06-21
BRAUN MANIFOLD (K942391)B.Braun Medical, Inc.1995-06-21
MSI PROCEDURE KIT (K944226)Msi, Inc.1995-06-21
LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY (K951854)Leonard Medical, Inc.1995-06-21
RYNEL MEDICAL FOAM (K951909)Rynel, Ltd. Inc.1995-06-21
EXPANDER WITH ACTIVE TONE CONTROL (K952454)Argosy Electronics1995-06-21
LISTENAIDER II (K952057)National Hearing Aid Dist., Inc.1995-06-21
FOCUS BALLOON DILATATION CATHETER (K952064)Cardiovascular Dynamics, Inc.1995-06-21
LEMAITRE VALVULOTOME II (K946352)Vascutech, Inc.1995-06-21
S-ROM ZTP UHMWPE ACETABULAR CUP (K951726)Joint Medical Products Corp.1995-06-21
GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) (K951911)Commercial Resources New Mexico, Ltd.1995-06-21
MAXIMA PLUS HOLLOW FIBER OXYGENATOR (K941473)Medtronic Vascular1995-06-21
CYBEX 770 (K950095)Cybex1995-06-21
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (K950419)Imed Corp.1995-06-21
GENT-L-KARE TRACHEOSTOMY TRAYS (K950851)Premium Plastics, Inc.1995-06-21
BIODERM MEDICAL HYDROGEL ISLAND DRESSING (K951166)Bioderm, Inc.1995-06-21
VERSATELL; VERSATELL-S (K941959)Progressive Concepts, Inc.1995-06-21
DUAL PURPOSE CATHETER (K945994)Universal Medical Products, Inc.1995-06-21
MICROFLOW IRRIGATION SYSTEM (K950078)Jedmed Instrument Co.1995-06-21
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) (K941793)Mountain Medical Equipment, Inc.1995-06-21
EVOLUTION(TM) MICROCATHETER (K945666)Boston Scientific Corp1995-06-21
FORTE CB (K951746)Chattanooga Group, Inc.1995-06-21
PISTON SYRINGE (K951871)Baxa Corp.1995-06-21
AUROLITE 80 (K952403)Argen Precious Metals, Inc.1995-06-21
1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES (K945836)Conmed Andover Medical, Inc.1995-06-20
MS EMULSION (K952123)Parkell, Inc.1995-06-20
CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES (K944126)Caltag Laboratories, Inc.1995-06-20
ORGENTEC ANTI-TG ELISA (K952130)American Laboratory Products Co., Ltd.1995-06-20
IMNI-II (K951983)Cottrell, Ltd.1995-06-20
CALTAG CD4 R-PE MONOCLONAL ANTIBODY (K944128)Caltag Laboratories, Inc.1995-06-20
CARBOMEDICS EXENDED MITRAL ROTATOR (K951368)Carbomedics, Inc.1995-06-20
CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY (K944127)Caltag Laboratories, Inc.1995-06-20
CONTRAST & RAPID HCG URINE/SERUM TST (K952319)Medix Biotech, Inc.1995-06-20
AMERLITE FERRITIN II ASSAY (K952286)Johnson & Johnson Clinical Diagnostics, Inc.1995-06-20
CEDIA DAU BENZODIAZEPINE ASSAY (K951710)Microgenics Corp.1995-06-20
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (K951169)Ciba Corning Diagnostics Corp.1995-06-20
SCHOLAR PATIENT MONITOR (K944860)Criticare Systems, Inc.1995-06-20
NEZHAT-DORSEY THERMAL RETENTION SYSTEM (K951300)American Hydro-Surgical Instruments, Inc.1995-06-20
3.3MM ACCESSORIES (K952448)Nobelpharma USA, Inc.1995-06-20
SYNERMED ISE REAGENTS (K952179)Synermed, Inc.1995-06-20
SIMMONS PLATING SYSTEM BOLT AND SCREW (K930353)Smith & Nephew, Inc.1995-06-20
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (K952246)Tri-Tech, Inc.1995-06-20
BOBES TONOMETER (K945446)Bobes S.A.1995-06-20
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Track 1995 automatically

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