Atlas FDA

1991

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

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RecordFirmDate
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES (K910083)Osteonics Corp.1991-04-01
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS (K910864)Vascutek, Ltd.1991-04-01
ENTREE SHEATH INTRODUCER SYSTEM (K904475)Cordis Corp.1991-04-01
E-Z-EM PULSED INFUSION SYSTEM (K905447)E-Z-Em, Inc.1991-04-01
CLEARVIEW HCG (K910946)Unipath , Ltd.1991-04-01
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS (K910865)Vascutek, Ltd.1991-04-01
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS (K910863)Vascutek, Ltd.1991-04-01
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS (K910866)Vascutek, Ltd.1991-04-01
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH. (K910425)Baxter Healthcare Corp1991-04-01
GAUZE SPONGES ABSORBENT GAUZE ROLLS (K910623)Liaoning-Usa Corp.1991-04-01
TEKDYNE MICRO RETRACTOR (K910975)Tekdyne1991-04-01
AMSET PLD SYSTEM (K905014)Advanced Med/Surg, Inc.1991-04-01
MICRO-VENT NEBULIZER SYSTEM (K904717)Tri/Bor Medical, Inc.1991-04-01
TEMPERATURE PROBE (K905148)Tec II Medical, Inc.1991-04-01
AERO-GEN NUBULIZER SYSTEM (K904718)Tri/Bor Medical, Inc.1991-04-01
SINGLE USE MANUAL RESUSCITATORS (K905002)Custom Medical, Inc.1991-03-29
C544 TRANSDUCER (K904459)Acuson Corp.1991-03-29
ORIGINEEDLE(TM) (K904849)Origin Medsystems, Inc.1991-03-29
ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH (K905831)Arzco Medical Electronics, Inc.1991-03-29
ALL BOND LINER-F (K910628)Bisco, Inc.1991-03-29
TENTATIVE OPERATING NAME-JAZZ BAND (K904805)Franklin M. Din D.M.D., P.A.1991-03-29
O BUTMENT (K903211)O Co., Inc.1991-03-29
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (K910282)Graphic Controls Corp.1991-03-29
VISI-STAPH (K905617)Connecticut Diagnostics, Ltd.1991-03-29
BIO SCAN-BG(TM (K910692)Bio Scan Instrument, Inc.1991-03-29
AMPRO SURGEON'S GLOVES (K910711)American Pro Latex, Inc.1991-03-29
DW 236 (K905204)Ivoclar North America, Inc.1991-03-29
PALPATION PROBE (K911159)Northgate Technologies, Inc.1991-03-29
BC 1219 HEALING HEAD (K904710)Minimatic Implant Technology1991-03-29
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM (K911158)Northgate Technologies, Inc.1991-03-29
VISIO-GEM ART-SYSTEM (K905604)Espe GmbH (Us)1991-03-29
LIGHT-TOUCH AND SURGI LIGHT FIBERS (K910726)Lifestream Int'L, Inc.1991-03-29
NONSTAINING ALASTIKS (K910288)Unitek Corp.1991-03-29
GESCO PER-Q-CATH REPAIR KIT (K910622)Gesco Intl., Inc.1991-03-29
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. (K902305)Armkel, LLC1991-03-29
CHOLESTEROL CALIBRATOR SET (K910962)Casco Standards1991-03-29
STEADFAST DENTURE ADHESIVE POWDER (K910216)Stiefel Research Institute, Inc.1991-03-29
CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS (K911180)Northgate Technologies, Inc.1991-03-29
TP AND DESIGN, CONDOM (K902324)China National Medicines & Health Prod. I/E Corp.1991-03-29
DATASCOPE MULTINEX ID MONITOR (K910106)Datascope Corp.1991-03-29
YOURS TRULY ASYMMETRICAL BREAST FORM (K911247)Jobst Institute, Inc.1991-03-29
ULTRASOUND TRANSMISSION GEL (K905545)Arbo Medical, Inc.1991-03-29
UST-974-5 CONVEX TRANSDUCER (K910153)Ge Medical Systems Information Technologies1991-03-29
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR (K905481)Northgate Technologies, Inc.1991-03-29
DU PONT IDENTIFICATION CAMERA (K910354)Dupont Medical Products1991-03-29
STREPTEX ACID EXTRACTION KIT (K910797)Wellcome Diagnostics1991-03-29
COMBO FETAL SCALP ELECTRODE/LEGPLATE (K905830)Utah Medical Products, Inc.1991-03-29
LAPAROFLATOR ELECTRONIC 3509 (K910883)F.M. Wiest USA, Inc.1991-03-29
FLOWIRE AND FLOMAP (K905411)Cardio Metrics, Inc.1991-03-29
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION (K910309)Baxter Healthcare Corp1991-03-29
THERMAPREP (K910224)Tulsa Dental Products, Ltd.1991-03-29
BC 1221 BALL OVERDENTURE ATTACHMENT (K904712)Minimatic Implant Technology1991-03-29
GSI 37 AUTO TYMP (K911095)Lucas Grason-Stadler, Inc.1991-03-29
RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL (K903011)Non-Invasive Monitoring Systems, Inc.1991-03-29
SWIRL PROPHYLAXIS PASTE (K903986)Bio-Medica Concepts1991-03-28
SURGICAL TISSUE POUCH (K910914)Cook Urological, Inc.1991-03-28
COMBINED MALAR IMPLANT (K910655)Implantech Associates, Inc.1991-03-28
AVD INTIMAX CHOLANGIOGRAPHY CATHETER (K910493)Applied Vascular Devices, Inc.1991-03-28
MEGA GENERAL PURPOSE INSTRUMENT KIT (K910366)Megadyne Medical Products, Inc.1991-03-28
INCISION AND DRAINAGE KIT (K910369)Megadyne Medical Products, Inc.1991-03-28
TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM (K905708)Trimedyne, Inc.1991-03-28
WOUND CLOSURE KIT (K910365)Megadyne Medical Products, Inc.1991-03-28
SURGICAL CLIPPER (K910524)Baxter Healthcare Corp1991-03-28
MEGA DRESSING CHANGE KIT (K910363)Megadyne Medical Products, Inc.1991-03-28
OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY (K905646)Norfolk Medical1991-03-27
BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS (K910196)C.R. Bard, Inc.1991-03-27
SUTURE REMOVAL KIT (K910361)Megadyne Medical Products, Inc.1991-03-27
THORA-KLEX CHEST DRAINAGE UNIT (K905448)Davol, Inc.1991-03-27
MC II (TM), MODEL 7200S (K903161)Medical Devices, Inc.1991-03-27
ORTHOCONCEPT ARTHROSCOPIC PUMP (K910164)Orthoconcept, Inc.1991-03-27
POST SURGICAL KIT/POST BIOPSY KIT (K910011)Dermatological Research Laboratories, Inc.1991-03-27
SLT MICROPLATE WASHER (K910740)Tecan U.S., Ltd.1991-03-27
G-TUBE DRESSING CHANGE TRAY (K905123)Continental Medical Laboratories, Inc.1991-03-27
CHF-B20 CHOLEDOCHOSCOPE (K904799)Olympus Corp.1991-03-27
MP4, MP4SI, IT4 INCUBATORS (K901157)Mediprema1991-03-27
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 (K910308)Inmark Corp.1991-03-27
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K904189)Ciba Corning Diagnostics Corp.1991-03-27
SIF-SW (K904800)Olympus Corp.1991-03-27
STRUNG TELFA NON-ADHERENT SPONGE (K904514)American Silk Sutures, Inc.1991-03-27
MINI-MICRON CIRCUIT (K903499)Medical Industries America, Inc.1991-03-27
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES (K910988)Osteonics Corp.1991-03-26
PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING (K910755)Intermedics Orthopedics1991-03-26
L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC (K904901)Parexel Intl. Corp.1991-03-26
DEVILBISS MODEL 7352 SERIES (K904766)Devilbiss Health Care, Inc.1991-03-26
NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON (K910019)Novametrix Medical Systems, Inc.1991-03-26
GLOBAL TOTAL SHOULDER (K905786)Depuy, Inc.1991-03-26
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE (K910464)W. L. Gore & Associates, Inc.1991-03-26
JETTA JR. HYDRO MASSAGE (K905599)Jetta Products, Inc.1991-03-26
ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) (K905785)Orthoconcept, Inc.1991-03-26
NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (K903493)North American Instrument Corp.1991-03-26
SMA 26 TRANSDUCER (K904902)Parexel Intl. Corp.1991-03-26
QUAD-LINK RETRACTABLE MOUNT (K911152)Tarsys Engineering, Inc.1991-03-26
OWENS CATHETER (K896520)Boston Scientific Corp1991-03-25
VESSEL DILATOR (K905416)The R Group1991-03-25
MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL (K910220)Toshiba America Mri, Inc.1991-03-25
ES/ULTRA DISPLAY AND PROCESSING STATION (K905412)Toshiba America Medical Systems, In.C1991-03-25
MAGNETOM 42 SP AND 63 SP (K910498)Siemens Medical Solutions USA, Inc.1991-03-25
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) (K904410)Meadox Medicals, Div. Boston Scientific Corp.1991-03-25
DYNAMIC SPECTRAL PHONOCARDIOGRAPH (K902185)Reeves Scientific, Inc.1991-03-25
DIAGNOSTIC INTRASCULAR CATHETER (K903848)Applied Vascular Devices, Inc.1991-03-25
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Every clearance here is in the API, with alerts when new ones post.