Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HEARTECH MODEL CH (K853219)Hearing Tech, Inc.1985-09-23
CONVEX PROBE, PVE-393M (K851526)Toshiba Medical Systems1985-09-23
DAHLBERG EB BEHING-THE-EAR HEARING AID (K853324)Miracle-Ear/Dahlberg, Inc.1985-09-23
RIONET HEARING AID HI-06 (K853636)Rion Acoustic Instruments, Inc.1985-09-23
JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET (K853527)Jufrey Multimed Corp.1985-09-23
METRONIC MODEL F7700 HEART VALVE SIZERS (K852612)Medtronic Vascular1985-09-23
UNIVAR UNIVERSAL DENTIN VARNISH (K852755)Scientific Pharmaceuticals, Inc.1985-09-23
HEARTECH MODEL(HTC) (HERITAGE) (K853218)Hearing Tech, Inc.1985-09-23
HEARTECH MODEL ILLUSION (K853220)Hearing Tech, Inc.1985-09-23
INSTRUMENT MAKAR DISPOSALBE LOOP (K853597)Instrument Makar, Inc.1985-09-23
HERAENIUM CA (K851515)Heraeus Dental Gold Corp.1985-09-23
DURA CONDITIONER (K852741)Reliance Dental Mfg. Co.1985-09-23
RIONET HEARING AID (K853638)Rion Acoustic Instruments, Inc.1985-09-23
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG (K852682)Calcitek, Inc.1985-09-23
PERSONAL AMPLIFIER COMMUNICATOR PREMIUM (K853606)Electone, Inc.1985-09-23
DAHLBERG EC BEHIND-THE-EAR HEARING AID (K853325)Miracle-Ear/Dahlberg, Inc.1985-09-23
RIONET HEARING AID HI-07 (K853637)Rion Acoustic Instruments, Inc.1985-09-23
TARGET CAT#B7850AA & B7850AB & B7850B (K851301)General Electric Co.1985-09-20
SAFE-N-JECT (K852304)Gerstner Intl. Trade1985-09-20
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM (K852543)Kontron Instruments, Inc.1985-09-20
PAO VALUE (K852990)Ackard Laboratories1985-09-20
TOMOMATIC 564 (K850416)M.I.D., Inc.1985-09-20
THE KENDALL URINARY OUTPUT MONITOR (K852083)The Kendal Co.1985-09-20
PHARMA-PLAST NEEDLE (K852442)Pharma-Plast USA, Inc.1985-09-20
VIAL DECANTER (K852893)Advance Medical Designs, Inc.1985-09-20
DAVOL RETRIEVAL BALLOON CATHETER (K853543)C.R. Bard, Inc.1985-09-20
KONTRON FAX FETAL MONITOR (K842422)Kontron Instruments, Inc.1985-09-20
IDECAP DIALYZER (K852764)Trans-National Trade Development Corp.1985-09-20
MIC-CONCEPT SYSTEM (K852613)Microtech Medical Systems, Inc.1985-09-20
SAFTI-BRACELET (K853418)Advanced Biosearch Assn.1985-09-20
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP (K852084)The Kendal Co.1985-09-20
STERILE DISPOSABLE SYRINGE(3 PIECES) (K852819)Fabersanitas, S.A.1985-09-20
N.K. PEDIATRIC CRIBS (K853355)N.K. Medical Products, Inc.1985-09-20
RT2600(115V)(220/240V) #H4008A & H4008AE (K851807)General Electric Co.1985-09-19
SELECTICULT-CHLAMYDIA (K852869)Scott Laboratories, Inc.1985-09-19
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 (K852572)Siemens Medical Solutions USA, Inc.1985-09-19
AUTO SUTURE TITANIUM HEMOSTATIC CLIP (K853650)United States Surgical, A Division of Tyco Healthc1985-09-19
ORALIX PANORAMIC D.C. (K852768)Philips Medical Systems, Inc.1985-09-19
NITTO SURGICAL PLASTIC TAPE ST-356 (K853644)Nitto Denko America, Inc.1985-09-19
ALLERCOAT ALLERGEN DISCS (K852794)Kallestad Laboratories, Inc.1985-09-19
IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C (K851828)Syncor Intl. Corp.1985-09-19
MOUNT TUBE RADIOGRAPHIC (K853682)X-Ray Systems1985-09-19
MIC-CONCEPT VIEWBOX (K853745)Microtech Medical Systems, Inc.1985-09-19
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES (K853456)Pharmacia, Inc.1985-09-19
IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (K853122)Immuno-Products Industries1985-09-19
NON-KOR ACCESS KITS (K852831)Creative Care Systems, Inc.1985-09-19
KM-2 METAL-BACKED ACETABULAR CUP (K844319)Kirschner Medical Corp.1985-09-19
DYNA GARD SYRINGE FILTER (K852996)Microgon, Inc.1985-09-19
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL (K852487)Fukuda Denshi USA, Inc.1985-09-19
TEGADERM PLUS TRANSPARENT DRESSING #952X (K852750)3M Company1985-09-19
FLOW EASE(PLASTIC VENTED NEEDLE) (K853212)Acacia, Inc.1985-09-19
AUTO PRO (K853378)Respiration Technology, Inc.1985-09-19
MSI-HB HEMOGLOBIN CONTROL (K853776)Medical Specialties, Inc.1985-09-19
FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY (K852696)Minnesota Laser Corp.1985-09-19
FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) (K852606)Infarkem Corp.1985-09-19
NEW JERSEY MODULAR FEMORAL HIP (K853655)Depuy, Inc.1985-09-19
NITTO SURGICAL NON-WOVEN TAPE ST-320 (K853646)Nitto Denko America, Inc.1985-09-19
5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517 (K852570)Siemens Medical Solutions USA, Inc.1985-09-19
MINI-HALO(HAND-HELD) CO2 LASER SYSTEM (K853319)Directed Energy, Inc.1985-09-19
THE KEYMED VARI-HEIGHT PATIENT COUCH (K853421)Keymed, Inc.1985-09-19
3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509 (K852571)Siemens Medical Solutions USA, Inc.1985-09-19
INFLATABLE AIR SPLINTS (K853600)Hospitak, Inc.1985-09-19
NITTO SURGICAL CLOTH TAPE ST-330 (K853645)Nitto Denko America, Inc.1985-09-19
BIOCHRON FERTILITY INDICATOR (K852801)Fertil-A-Chron, Inc.1985-09-19
YSI MODEL 790 TELE-THERMOMETER (K853551)Yellow Springs Instrument Co., Inc.1985-09-19
NITTO SURGICAL PAPER TAPE ST-310 (K853647)Nitto Denko America, Inc.1985-09-19
SIEMENS MEVATRON ME (K852907)Siemens Medical Laboratories, Inc.1985-09-19
MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (K850761)Medicor USA , Ltd.1985-09-19
LIFELINC LEADWIRE (K853303)Tronomed, Inc.1985-09-18
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS (K853548)American Dade1985-09-18
OXY-TWO (K852624)Ashai Co. , Ltd.1985-09-18
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS (K853371)Holter-Hausner Intl.1985-09-18
OXY-DIAL (K852618)Ashai Co. , Ltd.1985-09-18
CLS HIP PROSTHESIS (K852517)Advanced Biosearch Assn.1985-09-18
NEWPORT VENTILATOR MODEL E-100 (K852108)Newport Medical Instruments, Inc.1985-09-18
HUMPHREY FIELD ANALYZER MODEL 630 (K852639)Zeiss Humphrey System1985-09-18
NASAL ONE (K852628)Ashai Co. , Ltd.1985-09-18
AERO-MASK TWO (K852629)Ashai Co. , Ltd.1985-09-18
OXY-ONE (K852623)Ashai Co. , Ltd.1985-09-18
MCGHAN TISSUE EXPANDER FILL KIT (K853014)Mcghan Medical Corp.1985-09-18
BAYLOR RAPID AUTOTRANSFUSION SYSTEM (K852736)Cardio Systems, Inc.1985-09-18
TIP TOLEDO INCISOR PROTECTOR (K851640)Edward O. Goodwich1985-09-18
S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP (K851422)Joint Medical Products Corp.1985-09-18
H-H CATHETER PASSERS(TACL DESIGN (K853370)Holter-Hausner Intl.1985-09-18
ALGO I (K852687)Algotek, Inc.1985-09-18
AERO-MASK ONE (K852626)Ashai Co. , Ltd.1985-09-18
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY (K853628)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-18
OXY-TUBE (K852625)Ashai Co. , Ltd.1985-09-18
SONOLAYER-V, SSA-90A (K851036)Toshiba Medical Systems1985-09-17
TERGITOL 7 AGAR (K853691)Micro Media Laboratories1985-09-17
IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A (K852709)Telectronics, Inc.1985-09-17
REVIVE SYSTEM (K844445)Revive Systems Corp.1985-09-17
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT (K852512)Pacific Hemostasis1985-09-17
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 (K853221)Telectronics, Inc.1985-09-17
ABBOTT RSV EIA (K852472)Abbott Laboratories1985-09-17
ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP (K852446)Diag Corp.1985-09-17
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 (K853222)Telectronics, Inc.1985-09-17
TELEFLEX GUIDEWIRE (K850677)Teleflexmedical, Inc.1985-09-17
COLUMBIZ BLOOD AGAR (K853690)Micro Media Laboratories1985-09-17
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY (K852371)Abbott Diagnostics1985-09-17
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Every clearance here is in the API, with alerts when new ones post.