Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) (K903613)Harvard Apparatus, Inc.1990-11-07
STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX) (K904320)R.K.F. Laboratories, Inc.1990-11-07
PSC-1 W/OTHER NUMERICAL (K903821)Eigen1990-11-07
BIOCLONES ELEGANCE LH ELISA KIT (K904387)Bioclone Australia Pty , Ltd.1990-11-06
REFLOTRON POTASSIUM TEST TABS (K904033)Boehringer Mannheim Corp.1990-11-06
DUPONT SALICYLATE CALIBRATOR (K904307)E.I. Dupont DE Nemours & Co., Inc.1990-11-06
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS (K903441)Intl. Immunoassay Laboratories, Inc.1990-11-06
QMS TM- PHENYTOIN (K904815)Seradyn, Inc.1990-11-06
SIEMEN'S SIREMOBILE II C-ARM (K902983)Electromek Diagnostic Systems, Inc.1990-11-06
ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. (K903582)Catheter Sciences Co.1990-11-06
RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 (K904623)Atomic Products Corp.1990-11-06
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS (K903560)Marlo Surgical Technology1990-11-06
TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO (K904091)Lancer Orthodontics, Inc.1990-11-05
ARTERIAL BLOOD SAMPLING KIT (K902771)Medex, Inc.1990-11-05
ELEGANCE PROLACTIN ELISA (K904483)Bioclone Australia Pty , Ltd.1990-11-05
NELATON-, FEMALE - OR TIEMANN CATHETER (K896729)Unoplast A/S1990-11-05
WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC (K901015)Wright Medical Corp.1990-11-05
MODULOCK POSTERIOR SPINAL FIXATION (K902397)Zimmer, Inc.1990-11-05
SAFEBRIS STERILE CIRCUMCISION KIT (K902119)Kedumin Kits, Ltd.1990-11-05
MAGNUM (K904817)Everest & Jennings, Inc.1990-11-05
BACTTRAP (K903056)Pharma Systems, Inc.1990-11-05
CHILDRENS SUNGLASSES (K904197)Jasco Products Co., Inc.1990-11-05
MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT (K903878)Mentor O & O, Inc.1990-11-05
CEDIA(TM) PHENOBARBITAL ASSAY (K904413)Microgenics Corp.1990-11-05
MONOHAEM (FECAL OCCULT BLOOD TEST) (K901064)Silenus Laboratories Proprietary , Ltd.1990-11-05
GASTROGRAPH (K903646)Medics Instrument Corp.1990-11-05
CDI (TM) SYSTEM 100 MONITORING SYSTEM (K902654)3M Health Care, Ltd.1990-11-05
KWIKMIX (K904225)Baxa Corp., Sub. of Cook Group, Inc.1990-11-05
HANDI-TRACTION (K904862)Handi-Trak, Inc.1990-11-05
CHANLLENGE 1010 PATIENT KEY PROGRAM STATION (K903149)Maximum Performance Technologies, Mpts, Inc.1990-11-05
ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC. (K903555)Jason Marketing Co.1990-11-05
CAP-EVAC ADAPTER (K904803)Logan, Inc.1990-11-05
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) (K900720)Mortara Instrument, Inc.1990-11-05
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT (K904334)Pharmacia Deltec, Inc.1990-11-05
SOLARSHIELDS ENCORE (K903487)Dioptics1990-11-05
TSRH SACRAL L-CONNECTOR (K901587)Danek Medical, Inc.1990-11-05
ALLERGY CONTROL COVERS (K903382)Allergy Control Products, Inc.1990-11-02
SERACON CR REFERENCE (K904503)Bhp Diagnostix, Inc.1990-11-02
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES (K900371)Mentor Corp.1990-11-02
UNNA-SLEEVE(TM) (K903532)Aci Medical, Inc.1990-11-02
BRADLEY TENACULUM HOLDER (K903649)Marlo Surgical Technology1990-11-02
FRESENIUS AS 104 CELL SEPARATOR (K895435)Fresenius USA, Inc.1990-11-02
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (K904666)Amersham Corp.1990-11-02
QBC SYSTEM MCHC (K904675)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-11-02
QUALICHECK 3 (K904733)Radiometer America, Inc.1990-11-02
COMPUTED TOMOGRAPHY X-RAY SYSTEM (K903763)General Electric Co.1990-11-02
AFGA VIDEO IMAGER, VARIOUS MODELS (K903238)Enhanced Imaging Technologies, Inc.1990-11-02
LATEX EXAMINATION GLOVES (K902956)Pacificlink Export Industries Private , Ltd.1990-11-02
SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 (K904479)Percutaneous Technologies1990-11-02
HOLDER, DENTAL BUR, ALUMINUM (K904278)Maverick Surgical, Inc.1990-11-02
PERMA MESH (K904089)Lancer Orthodontics, Inc.1990-11-02
HEVEASHIELD EXAMINATION GLOVES (K902700)Pacificlink Export1990-11-02
C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE (K904094)Lancer Orthodontics, Inc.1990-11-02
CYTOSMEAR BRUSH (K904160)Brooke Intl.1990-11-02
UNOMETER 500 (K896732)Unoplast A/S1990-11-02
VASCUMED EZ Y-CONNECTOR (K902741)Vascumed Systems1990-11-01
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST (K904497)Biotrax, Inc.1990-11-01
AMICON DIAFILTER 30 HEMOCONCENTRATOR (K902837)Amicon, Inc.1990-11-01
THROMBELASTOGRAPH (K904204)Haemoscope Corp.1990-11-01
PERTAC UNIVERSAL BOND (K904289)Espe GmbH (Us)1990-11-01
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT (K904635)Immunotech Corp.1990-11-01
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III (K904141)Medical Analysis Systems, Inc.1990-11-01
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE (K902958)Board of Directors, Albert Browne , Ltd.1990-11-01
OTICAON BTE MODEL E34P (K904673)Oticon Corp.1990-11-01
ARGENCO 19 (K904437)Argen Precious Metals, Inc.1990-11-01
CLINICAL BLOOD GAS MIXTURES (K904163)Norco, Inc.1990-11-01
OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS (K904757)Medical Fittings, Inc.1990-10-31
ELLA BREAST FORM (K904085)Coloplast A/S1990-10-31
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER (K900094)Boston Scientific Corp1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (K903747)Downs Surgical , Ltd.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (K903750)Downs Surgical , Ltd.1990-10-31
MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS (K904702)Medical Fittings, Inc.1990-10-31
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR (K902478)Physio-Control Corp.1990-10-31
MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN (K904701)Medical Fittings, Inc.1990-10-31
ARGENCO 22 (K904343)Argen Precious Metals, Inc.1990-10-31
CUSTOMED LAP PACK II (K902191)Customed, Inc.1990-10-31
HME-10 (TM) (K903054)Pharma Systems, Inc.1990-10-31
TKO TELESCOPING LITHOTOMY STIRRUP (K904826)D.L. Nelson and Assoc., Inc.1990-10-31
SCOPESCRUBBER(TM) (K902683)Healthtek Microsurgical, Inc.1990-10-31
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. (K904273)Carter Products1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (K903749)Downs Surgical , Ltd.1990-10-31
INVOTEC POLY-MESH MANDIBULAR TRAY (K901923)Invotec International, Inc.1990-10-31
URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (K903816)Respiratory Support Products, Inc.1990-10-31
MODEL 1850 ELECTRODE (K903918)Medtronic Vascular1990-10-31
ARGILITE 3 (K904467)Argen Precious Metals, Inc.1990-10-31
PRIZM HEARING SYSTEM (K902846)Audioscience, Inc.1990-10-31
BIO-MEDICUS CANNULA INTRODUCER (K903410)Bio Medicus, Inc.1990-10-31
BARD MICROBORE ANTI-SIPHON NITRO SET (K900217)C.R. Bard, Inc.1990-10-31
OMRON PULSE STIMULATOR MODEL HV-F05 (K902255)Omron Electronics, Inc.1990-10-31
GERARD MEDICAL, INC. TRIM-PORT (K903364)Gerard Medical Enterprises, Inc.1990-10-31
SUCTION SYSTEM (K904218)Axiom Medical, Inc.1990-10-31
SENSATRACE (K904185)Ludlow Corp., Technical Papers Division1990-10-31
CUSTOMED CYSTO PACK II (K901705)Customed, Inc.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (K903748)Downs Surgical , Ltd.1990-10-31
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID (K904544)Qualitone1990-10-31
SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER (K902778)Surgical Dynamics, Inc.1990-10-30
VISIRASER (K904126)Acorn Group, Inc.1990-10-30
ACCU PATH STERILE LABEL (K904598)Accu-Path1990-10-30
LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER (K902056)Hollister, Inc.1990-10-30
QUALTEX NEEDLE COUNTERS (K903947)Deroyal Industries, Inc.1990-10-30
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Every clearance here is in the API, with alerts when new ones post.