Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
INTERVENTIONAL PRODUCTS - GUIDE WIRES (K890207)E-Z-Em, Inc.1989-05-31
OMRON TRAVEL MASSAGER, MODEL HM-01 (K893029)Omron Electronics, Inc.1989-05-31
OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1 (K891225)Canon USA, Inc.1989-05-31
PROTEX (PATIENT EXAMINATION GLOVES) (K892102)Hon Shan Development , Ltd.1989-05-31
LEONARD TUBE (K892334)Surgidyne, Inc.1989-05-31
PATIENT EXAM GLOVE (MFG. DALIAN LATEX & JIN ZHOU) (K891863)China Xinxing Corp. , Ltd.1989-05-31
DURAPRO (PATIENT EXAMINATION GLOVES) (K892130)Perfekta Intl., Ltd.1989-05-31
URODEC 500 (K890284)Ferguson Medical1989-05-30
ARGEDENT 52 (DENTAL ALLOY) (K891989)Argen Precious Metals, Inc.1989-05-30
NEEDLEPOINT GUARD (K892405)Urological Assoc. of Grand Island, P.C.1989-05-30
VASCULAR ACCESS PORT CONTINUOUS INFUSION SET (K891226)Infucare Products, Inc.1989-05-30
ESPE CAPMIX (K891064)Espe GmbH (Us)1989-05-30
TECNOL NASO-GASTRIC TUBE HOLDER (K891187)Tecnol New Jersey Wound Care, Inc.1989-05-30
PROXIMATE LINEAR CUTTER THICK TISSUE INST. (K892927)ETHICON, Inc.1989-05-26
MAGNILINK SYSTEM 602 (K892351)Coburn Optical Ind., Inc.1989-05-26
ORTHO-J, INC. BEK-JS-004 (K891917)Ortho-J, Inc.1989-05-26
LEUCOPREP CELL SEPARATION TUBE (K891407)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-05-26
ESPE TULUX-CEM (K891020)Espe GmbH (Us)1989-05-26
ACUDATA INDICATENS MODEL 5X (K890088)Acudata Software1989-05-26
SPINALATOR JS-1100 TRACTION UNIT (K893168)The Spinalator Co.1989-05-26
VITRECTOMY PACK #J120 (K891161)O.R. Specialties, Inc.1989-05-26
COMFORTRAC, CT90 & CT100 BI-PHASICS (K892669)Comfortrac Systems1989-05-26
ANGIOTEC ZX DIGITAL IMAGE PROCESSOR (K892869)Andros Analyzers, Inc.1989-05-26
MAGNILINK SYSTEM 101 (K892347)Coburn Optical Ind., Inc.1989-05-26
MAGNILINK SYSTEM 201 (K892348)Coburn Optical Ind., Inc.1989-05-26
MAGNILINK SYSTEM 402/5 (K892350)Coburn Optical Ind., Inc.1989-05-26
RESUBMITTED CLW ACETABULAR CUP W/SULMESH (K883794)Protek, Inc.1989-05-26
STERILE BURNNET PRE-CUT (VARIOUS SIZES) (K891459)Western Medical, Ltd.1989-05-26
MAGNILINK SYSTEM 209 (K892349)Coburn Optical Ind., Inc.1989-05-26
TEMPTEK 5010 THERMAL COOLING BLANKET (K891092)Temptek, Inc.1989-05-26
GENESIS TM FETAL SYSTEM (K882084)Pediatric Diagnostic Service1989-05-26
JUMPER PACK #203 (K890825)O.R. Specialties, Inc.1989-05-26
LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS (K891909)Lifestream Int'L, Inc.1989-05-26
MINI-DIAMOND KNIFE (K893033)L.A.B. Instruments1989-05-26
ALPHA MALLARD (K893248)Alpha Unlimited, Inc.1989-05-26
MODIFIED ADULT CRICOTHYROIDOTOMY KIT (K885139)Pertrach1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K891949)Phoenix Medical Technology, Inc.1989-05-25
PATIENT EXAM GLOVES (MFG. YU HUA LATEX FACTORY) (K892022)Brilliant Ray Intl., Inc.1989-05-25
INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES (K891105)Acudata Software1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K892304)Saraf Chemicals Pvt. , Ltd.1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K892761)E-Full Industrial , Ltd.1989-05-25
PATIENT EXAM GLOVES (MFG. BEIJING LATEX FACTORY) (K892025)Brilliant Ray Intl., Inc.1989-05-25
INDICATENS INDICATOR ELECTRODE MODEL 2 (K891107)Acudata Software1989-05-25
PERRY* NON-STERILE X-AM* GLOVES (K892353)Smith & Nephew Medical1989-05-25
PATIENT EXAMINATION GLOVES (K892462)Hollymount Trading & Mfg.1989-05-25
PATIENT EXAMINATION GLOVE (LATEX) (K891881)Cymun Development Sdn Bhd1989-05-25
NIL (PATIENT EXAMINATION GLOVES - LATEX) (K891865)Medicare Industries, Inc.1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K892111)Maika Holdings Sdn. Bhd.1989-05-25
STERILE PATIENT EXAMINATION GLOVE (K892554)Shun Thai Rubber Gloves Industry Co., Ltd.1989-05-25
PATIENT EXAM GLOVES (MFG. XIAN WELFARE LATEX ) (K892023)Brilliant Ray Intl., Inc.1989-05-25
PROLAX PATIENT EXAMINATION GLOVES (LATEX) (K892026)Ergo Intl., Ent., Inc.1989-05-25
MAYTEX PATIENT EXAMINATION GLOVES (K892553)American Seal Co.1989-05-25
LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) (K891728)Baldur Systems Corp.1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K892567)Anhui Light Industrial Products I/E Corp.1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K892683)Vollrath Group, Inc.1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K891661)Dmp, Inc.1989-05-25
FLEX-CUP PERCUSSOR (K892862)Life Design Systems, Inc.1989-05-25
MOBILAIRE V OXYGEN CONCENTRATOR (K891488)Invacare Corp.1989-05-25
OXITRON OXYGEN SENSOR (K890144)Oxitron Medical Products1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K891736)Quest Intl., Inc.1989-05-25
YUPOND LATEX EXAMINATION GLOVES (K891959)Yupond Ent. Co., Ltd.1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K891864)Pt Latexindo Lestari1989-05-25
PLASTER CUTTING SCISSORS (K892823)The South India Surgical Co. Pvt. , Ltd.1989-05-25
PATIENT EXAMINATION GLOVES (LATEX) (K892742)Shen Wei (Usa), Inc.1989-05-25
PATIENT EXAM GLOVES (MFG. POLYMINT INDUSTRIAL CO.) (K892686)Intl. Visco Group1989-05-25
PATIENT EXAM GLOVES (MFG. CHAGAN TANG CAPITOL) (K892024)Brilliant Ray Intl., Inc.1989-05-25
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 (K892648)Boston Scientific Corp1989-05-24
OCTYLDENT (K884652)Crx Medical, Inc.1989-05-24
AMRESCO URIC ACID REAGENTS #7628 (K892395)American Research Products Co.1989-05-24
SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED (K892522)Gespac, Inc.1989-05-24
VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS (K891133)Elwyn, Inc.1989-05-24
SDI PREPAX COUNTAPETTE KIT (K892658)Scientific Distributors, Inc.1989-05-24
S-FILE, S-FINDER, S-ENGINE FILE (K892894)Svenska Dental Instruments AB1989-05-24
QUICK-TIP (DENTAL OPERATORY UNIT) (K891006)Bernard S Esrock1989-05-24
HCG IRMA II (K891770)Pacific Biotech, Inc.1989-05-24
LOKSHOT PISTON SYRINGE (K891467)Flp Ent., Inc.1989-05-24
AREOLA/NIPPLE DRESSING (K882558)Cooper Surgical/Aesthete1989-05-24
HEALTHSHIELD (K885345)Jonas, Inc.1989-05-24
PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (K890095)Kells Medical, Inc.1989-05-24
IF-II (TM), MODEL 9800 (K883462)Medical Devices, Inc.1989-05-24
ARGELITE 60+ (K893012)Argen Precious Metals, Inc.1989-05-24
ORIENT, LATEX SURGICAL GLOVES, STERILE (K884882)Rosa Intl.1989-05-24
WEDGE PRESSURE DRESSING (K891189)Durden Enterprises, Inc.1989-05-24
MEDIVERSE PARENTERAL NUTRITION BAG (K891077)Mediflex Intl.1989-05-24
MERIFLUOR(TM) -TRICHOMONAS (K892263)Meridian Diagnostics, Inc.1989-05-24
ARGEDENT 87 (K892662)Argen Precious Metals, Inc.1989-05-24
EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (K890094)Kells Medical, Inc.1989-05-24
TECNOL SECURE-ALL TUBE HOLDER (K891178)Tecnol New Jersey Wound Care, Inc.1989-05-23
ENTERAL BAG/SET (K890151)Ashley Health Care, Inc.1989-05-23
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (K893013)Luxar Medical Laser Instruments1989-05-23
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S (K892006)Healthdyne, Inc.1989-05-23
LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC (K891130)Lifestream Int'L, Inc.1989-05-23
THE CDI(R) SYSTEM 400 (K890113)Cardiovascular Devices, Inc.1989-05-23
PERIPHERAL ATHERECTOMY SYSTEM (K890515)Intensive Technology, Inc.1989-05-23
MCINTYRE SURGICAL GONIOLENS (K890977)Ocular Instruments, Inc.1989-05-23
BEAM TECH WOUND DRESSING* (K890603)Beam Tech , Ltd.1989-05-23
GRAND GUARD SURGICAL GLOVES (K892061)Galaxy Intl., Inc.1989-05-23
EXTERNAL FEEDING SET FOR PUMP USE (K890396)Multi-Med, Inc.1989-05-23
MRL BLOOD PRESSURE MONITOR (K885191)Medical Research Laboratories, Inc.1989-05-23
BIPOLAR HIP SYSTEM (K892398)Orthomet, Inc.1989-05-23
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Every clearance here is in the API, with alerts when new ones post.