Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COMPRINET, COMTESSE AND BELLAVAR STOCKINGS (K905631)Jobst Institute, Inc.1991-03-07
JOSLYN EO STERILIZER/ EO MODERNIZATION KIT (K901146)Joslyn Valve Corp.1991-03-07
COMPANION SPEECH AID, MODEL 432 (K910796)Companion Products Intl.1991-03-07
VYGON LIFEVAC PICC (K903648)Vygon Corp.1991-03-07
LARES 757 WORKHORSE HIGHSPEED HANDPIECE (K905541)Lares Research, Inc.1991-03-07
COMPANION SPEECH AID, MODEL 160 (K910819)Companion Products Intl.1991-03-07
AM GLOVES STERILE VINYL EXAMINATION (K910774)Am Gloves Co., Ltd.1991-03-07
SUNTEX STERILE EXAM GLOVES (K910631)P.T. Latexindo Prautama1991-03-07
VPW 2877E6 X-RAY POWER SUPPLY (K910820)Varian Canada, Inc.1991-03-07
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* (K910586)United States Surgical, A Division of Tyco Healthc1991-03-07
ZIMMER CERAMIC FEMORAL HEADS (K905739)Zimmer, Inc.1991-03-07
BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC (K910660)Boston Medical Corp.1991-03-07
JM GLOVES STERILE VINYL EXAMINATION (K910775)Jm Gloves Co., Ltd.1991-03-07
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (K904878)Hpi, Inc.1991-03-07
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY (K910343)Ciba Corning Diagnostics Corp.1991-03-06
CLINAK(TM) ISE SUBSYSTEM (K910554)Baxter Healthcare Corp1991-03-06
CRI CYNOSAR CATHETER (K904785)Catheter Research C/O Burditt, Bowles & Radzius1991-03-06
X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 (K910276)Inmark Corp.1991-03-06
ORTHOVISION TABLE (K905816)American Sterilizer Co.1991-03-06
GAUZE SPONGES, INTERNAL AND EXTERNAL (K905136)American Healthcare Corp.1991-03-06
DISPOSABLE YANKAUER SUCTION TUBE (K904881)Pilling Medical S.A.1991-03-06
INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (K904265)Inamed Development Co.1991-03-06
CRP LIPID REAGENT TEST PACK (K905648)Cirrus Diagnostics, Inc.1991-03-06
KEY COMFORT GRIPS (K910328)Key Surgical, Inc.1991-03-06
MICRO-X 80HF (K905695)Fischer Imaging Corp.1991-03-06
HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS (K905759)Marlo Surgical Technology1991-03-06
CONVATEC ABSORBENT BANDAGE (K904233)Convatec, A Division of E.R. Squibb & Sons1991-03-06
LAPAROTOMY SPONGES (K905135)American Healthcare Corp.1991-03-06
POLYURETHANE CONDOM (K902936)Apex Medical Technologies, Inc.1991-03-06
VIDEO ENDOSCOPE, RIGID (K903339)Medical Dynamics, Inc.1991-03-06
OMIBAND (K904445)Omikron Scientific, Ltd.1991-03-06
MILENIA BETA-2 MICROGLOBULIN (K910052)Diagnostic Products Corp.1991-03-06
ELLIPSE PUNCH (K904869)Kramer Const1991-03-06
DRAINAGE TUBE RESTRAINT/WOUND COVER (K905766)M. Imonti and Associates Inc.,1991-03-06
DI2000/HS-45-150 X-RAY TUBE INSERT (K910842)Comet Ltd. C/O Radiology Resources, Inc.1991-03-06
E-20 RAPID CUFF INFLATOR (K905367)D. E. Hokanson, Inc.1991-03-06
NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY (K905181)Meadox Surgimed, Inc.1991-03-06
MONTROSE DRESSING APPLICATORS (K905519)Olemunda Pty , Ltd.1991-03-06
HEMAGEN ENA SCREENING KIT (K910232)Hemagen Diagnostics, Inc.1991-03-06
ANTI-FOR SURGICAL FACE MASK (K905865)Anago, Inc.1991-03-06
OPTILASE (TM) MODEL 900 ARGON (K903838)Trimedyne, Inc.1991-03-05
SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM (K904396)Simplex Medical Systems, Inc.1991-03-05
ESI-3000 ULTRASOUND SYSTEM (K904359)Elscint, Inc.1991-03-05
SOLID CORE GUTTA PERCHA CARRIER (K905640)The Hygenic Corp.1991-03-05
FORTRESS EDGE MANUAL RIGID WHEELCHAIR (K910748)Fortress Litestyle1991-03-05
ARTIFLEX(TM) (K910274)Beiersdorf, Inc.1991-03-05
CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND (K905453)Douglas James Donaldson Compliance Services1991-03-05
THE UNIVERSAL CEMENT PLUG(TM) (K910135)Biotron , Ltd.1991-03-05
FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR (K910750)Fortress Litestyle1991-03-05
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8) (K904793)Surgitek1991-03-05
FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR (K910752)Fortress Litestyle1991-03-05
FUJINON EVL-F (TENTATIVE) AND TROCAR (K902197)Fujinon, Inc.1991-03-05
PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (K905461)Angiosystems, Inc.1991-03-05
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA (K910517)Pharmacia, Inc.1991-03-05
MANGAR BOOSTER (K905414)Northfleet Management Group, Inc.1991-03-05
FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR (K910746)Fortress Litestyle1991-03-05
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS (K905264)Nova Biomedical Corp.1991-03-05
CODMAN NEUROLASE LASER SYSTEM/MODIFICATION (K905511)I.L. Med, Inc.1991-03-05
QUICK-CLIP NEEDLE GUIDE (K903561)Acuson Corp.1991-03-05
SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE (K905451)Advanced Osseous Technologies1991-03-05
EF SYNERGY QUAD MODIFIED (K910242)Remel Co.1991-03-05
ALTA(R) PFX IM ROD (K903526)Howmedica Corp.1991-03-05
SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) (K904797)Surgitek1991-03-05
APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM (K905781)Intermedics Orthopedics1991-03-04
OFLOXACIN, 5 MCG SENSI-DISC (K910506)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-03-04
DELUXE SANITARY PAD (K905178)American Healthcare Corp.1991-03-04
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR (K902405)Mallinckrodt Medical1991-03-04
CANDELA DIODE TRABECULOPLASTY LASER DTL (K910612)Candela Laser Corp.1991-03-04
AIR PLUS NEBULIZER (K902520)Diamond Medical Equipment, Inc.1991-03-04
COMPACT LASER IMAGER, MODEL CLI-100 (K902347)Lumisys, Inc.1991-03-04
NEON RUBBER SUNGLASSES (K905183)Ha-Lo Advertising Specialties, Inc.1991-03-04
KTP DISC KIT (K905424)Laserscope1991-03-04
3M BRAND EAR LOOP FACE MASK, 2000F (K910182)3M Company1991-03-04
SURGICAL FACE MASK (K905749)Anago, Inc.1991-03-04
NOBELPHARMA DRILLING EQUIPMENT DEC 500 (K905436)Nobelpharma USA, Inc.1991-03-04
LAPAROSCOPE (K905196)Baxter Healthcare Corp1991-03-04
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED (K910108)Gds Diagnostics1991-03-04
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (K910252)CooperSurgical, Inc.1991-03-04
VARIOUS MALE QUICK CONNECTS. (K905091)Medical Fittings, Inc.1991-03-04
NEXUS ACETABULAR CUP (K905408)Dow Corning Wright1991-03-01
TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (K904749)Transtracheal Systems1991-03-01
TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (K904748)Transtracheal Systems1991-03-01
MICRORATE INTELLIGENT PUMP (K905610)Kendall Mcgaw Laboratories, Inc.1991-03-01
MICRORATE PLUS INTELLIGENT PUMP (K905611)Kendall Mcgaw Laboratories, Inc.1991-03-01
HORIZON 2000 ST ANALYSIS OPTION (K903524)Mennen Medical, Inc.1991-03-01
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM (K905530)Puritan Bennett Corp.1991-03-01
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD (K902672)Intermedics, Inc.1991-03-01
NEEDLE, DIALYSIS (K902564)Gainor Medical Europe, Ltd.1991-03-01
PILLING BRUSH VALVULOTOME (K904507)Pilling Co.1991-03-01
CORDIS REFLEX STEERABLE GUIDEWIRE (K905423)Cordis Corp.1991-03-01
MYOTRACK, MODEL HH 515 (K904025)Myotrack Co.1991-03-01
MODEL 405 (K904606)Ivy Biomedical Systems, Inc.1991-03-01
ACTIVE MODEL AMC MINI CANAL ITE HEARING AID (K910704)Active Electronics, Inc.1991-02-28
ACTIVE MODEL AHX HELIX ITE HEARING AID (K910705)Active Electronics, Inc.1991-02-28
THE EYEGAZE SYSTEM (K905474)Lc Technologies, Inc.1991-02-28
PHILIPS MODEL S46-O BTE HEARING AID (K910744)Philips Hearing Instruments Co.1991-02-28
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS (K905248)Advanced Technology Laboratories, Inc.1991-02-28
3M MODEL 8245 ITE HEARING AID (K910763)3M Company1991-02-28
BLOM-SINGER SHOWER GUARD (K904729)Helix Medical, Inc.1991-02-28
ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID (K910701)Active Electronics, Inc.1991-02-28
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Every clearance here is in the API, with alerts when new ones post.