Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AAP BONE PLATE (K915315)Aap International, Ltd.1992-02-20
FOIL BABY BUNTING (K915303)Gam Industries, Inc.1992-02-20
SKYTRON INFINITY SERIES SURGICAL LIGHTS (K915285)Skytron, Div. the Kmw Group, Inc.1992-02-20
ABBOTT SMART CAP (K915304)Abbott Laboratories1992-02-19
TRAC-WRIGHT TRAC 10 CATHETER (K915238)Dow Corning Wright1992-02-19
WATERS 717 AUTOSAMPLER (K920136)Millipore Corp.1992-02-19
URODYNAMIC CATHETER (K915443)Cook Urological, Inc.1992-02-19
ETEX DENTAL IMPLANT SYSTEM (K913417)Etex Co.1992-02-19
RIONET HEARING AID HB-23M (K920522)Authorized Hearing Systems, Inc.1992-02-19
IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (K914953)Stellar Bio Systems, Inc.1992-02-19
OPTICAL FRAMES & SUNGLASSES (K914310)Societe Nouvelle Idc1992-02-19
URESIL FIXATION DEVICE (K914699)Uresil Corp.1992-02-19
CORDIS RIGHT-ANGLE CATHETER GUIDE (K913842)Cordis Corp.1992-02-19
RIONET HEARING AID HB-23T (K920521)Authorized Hearing Systems, Inc.1992-02-19
PROFLEX 5 (K915168)Peripheral Systems Group1992-02-19
KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL (K915309)Kinamed, Inc.1992-02-19
KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL (K915310)Kinamed, Inc.1992-02-19
AM 300 AGC-O (K914948)Electone, Inc.1992-02-19
IMX ESTRADIOL (K920047)Abbott Laboratories1992-02-18
SMALL JOINT SYSTEM (K914559)Smith & Nephew Dyonics, Inc.1992-02-18
PREMIER CLASS D-ASP (K914798)Electone, Inc.1992-02-18
MODEL 795 FLUOROMETER/DENSITOMETER (K915332)Ciba Corning Diagnostics Corp.1992-02-18
UNIVERSAL FEMORAL NAIL (K914371)Synthes (Usa)1992-02-18
PREMIER K-AMP (K914799)Electone, Inc.1992-02-18
MINI VIBRATOR (K920487)Alimed, Inc.1992-02-18
ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. (K920184)Mbo Laboratories, Inc.1992-02-18
LIPASE REAGENT SET (K915706)Tech Intl. Co.1992-02-18
EMIT D.A.U BENZODIAZEPINE ASSAY (K915501)Syva Co.1992-02-18
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 (K914135)Amersham Corp.1992-02-18
AFFINITY PRG (K920230)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-18
CONTINUUM KNEE SYSTEM (CKS) (K914072)Techmedica, Inc.1992-02-18
MICROPROTEIN-PR (K915380)Sigma Diagnostics, Inc.1992-02-18
3D PROCESSING OPTIONS FOR GYREX (K915579)Elscint, Inc.1992-02-18
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL (K914453)Synthes (Usa)1992-02-18
HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE (K912778)Sensititre Microbiology A Div. of Radiometer1992-02-18
A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES (K915300)Alto Development Corp.1992-02-18
ANGEION ENDOSCOPIC VALVE SEAL (K915719)Angeion Corp.1992-02-18
IL TEST(TM) AMLYLASE (K913744)Instrumentation Laboratory CO1992-02-18
PREMIER ASP/CD RECHARGEABLE (K914796)Electone, Inc.1992-02-18
SCANLAN/TAHERI VALVULOTOME (K911184)Scanlan Intl., Inc.1992-02-18
CYTOLOGY BRUSH (K914504)Surgitek Medical Engineering Corp.1992-02-18
XLP NETWORK PRINTING (K914191)Vortech Data, Inc.1992-02-18
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM (K912444)Radiometer America, Inc.1992-02-18
MODEL 6984M LEAD EXTENDER KIT (K915724)Medtronic Vascular1992-02-18
GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE (K913696)Vertex Technical Group, Inc.1992-02-18
AM 300 XP (K914947)Electone, Inc.1992-02-18
MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE (K914874)Manan Medical Products, Inc.1992-02-18
ELECTONE/PA RECHARGEABLE (K914795)Electone, Inc.1992-02-18
PREMIER CD RECHARGEABLE (K914797)Electone, Inc.1992-02-18
AFFINITY B12 (K920078)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-14
SURGICAL APPAREL (K914832)W. L. Gore & Associates, Inc.1992-02-14
CMV IGG ELISA TEST (K915892)Gull Laboratories, Inc.1992-02-14
7000 SERIES MODULAR TIBIAL COMPONENTS (K915192)Osteonics Corp.1992-02-14
RIONET HEARING AID HB-53P (K920486)Authorized Hearing Systems, Inc.1992-02-14
ELECTRODE (K912643)Skylark Device Co., Ltd.1992-02-14
3100 INFUSION PUMP (K912192)Graseby Medical , Ltd.1992-02-14
MOSS - ANCHOR SET (K913701)Moss Medical Products1992-02-14
GYREX 2T-DLX (K915601)Elscint, Inc.1992-02-14
ANESTHESIA BREATHING CIRCUIT (K915452)Concord/Portex1992-02-14
AAP BONE SCREW (K915316)Aap International, Ltd.1992-02-14
MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG (K915760)Corazonic Corp.1992-02-14
DANEK SPINALSCOPE (K901692)Danek Medical, Inc.1992-02-14
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (K912666)Dako Corp.1992-02-14
DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP (K915207)Bay Technical Products, Inc.1992-02-14
LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION (K912189)Physio-Control Corp.1992-02-14
CLINITRON C-10 (K914351)Ssi Medical Services, Inc.1992-02-14
CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER (K915374)Cordis Corp.1992-02-14
3000 INFUSION PUMP (K912193)Graseby Medical , Ltd.1992-02-14
SOF-FLEX LAPAROSCOPIC BASKET (K913299)Cook Ob/Gyn1992-02-14
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT (K920253)Medix Biotech, Inc.1992-02-14
ELLAGIC ACID APTT REAGENT (K915418)Helena Laboratories1992-02-14
7000 SERIES TOTAL KNEE PATELLAR COMPONENTS (K915186)Osteonics Corp.1992-02-14
PTI ANNULOPLASTY RING(STERILE) (K905175)Pioneering Technologies, Inc.1992-02-14
RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM (K911835)Gs Microsystems1992-02-14
ACACIAS PHARM/PUMP (K912771)Acacia, Inc.1992-02-14
EBV-VCA IGM ELISA (K915348)Pharmacia Diagnostics, Inc.1992-02-14
GUIDER DASHER (K915115)Target Therapeutics1992-02-14
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE (K915623)Shimadzu Medical Systems1992-02-14
ENZYMUN-TEST TSH (K915195)Boehringer Mannheim Corp.1992-02-14
BONE SCREW 3.5 MM (K915613)Acu Med, Inc.1992-02-13
SINGLE USE LEE ELECTRODE (K913213)Aspen Laboratories, Inc.1992-02-13
GI BLEEDER/OD SET (K913476)Icu Medical, Inc.1992-02-12
HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K915282)Hemagen Diagnostics, Inc.1992-02-12
REGENCY, COMPARE, SUN OPTICS SUNGLASSES (K913419)Cliff Weil, Inc.1992-02-12
POWER TRAINER WITH NEUROMUSCULAR STIMULATION (K904509)Sinties Scientific, Inc.1992-02-12
STABILET INFANT RADIANT WARMER MODEL 2000C (K913945)Hill-Rom, Inc.1992-02-12
KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE (K920031)Eastman Kodak Company1992-02-12
SUREBREATH DOME, E-Z BREATHER (K915158)Ipax, Inc.1992-02-12
SIMPLASTIN L (K915746)Organon Teknika Corp.1992-02-12
I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR (K914118)I.C Medical, Inc.1992-02-12
PHACO 3000 LINEAR (K915456)Innovative Medical Systems, Inc.1992-02-12
SUNGLASSES (NON-PRESCRIPTION) (K920165)Blair Corporation1992-02-11
SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 (K915768)Surgical Laser Products, Inc.1992-02-11
SAUNETTE, PORTABLE STEAM CABIN (K914234)Sauna Magic, Inc.1992-02-11
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM (K915132)Biomet, Inc.1992-02-11
PRE-ANGLED ABUTMENTS (K912059)Core-Vent Corp.1992-02-11
TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM (K915297)Lifeguard Medical Products, Inc.1992-02-11
ULTRA R-11 CRUISER (K915609)Brookefield Hunter, Inc.1992-02-11
LATEX MED.EXAM.GLOVES POWDERED AMBIDEXTROUS (K915126)Hedd Roz Canada, Inc.1992-02-11
I.V.IRRIGATION POLE (K915065)American Medical Mfg., Inc.1992-02-11
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Every clearance here is in the API, with alerts when new ones post.