Atlas FDA

1989

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

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RecordFirmDate
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II (K894078)Bio-Rad1989-08-11
PATIENT EXAMINATION GLOVES (VINYL) (K892743)Olympia & Pacific Plastics Industry Corp.1989-08-10
EXCEL (TM) CHEMISTRY ANALYZER (K893137)American Monitor Corp.1989-08-10
BIOTROL CALCIUM MONOREACTIF (K891061)Biotrol, USA, Inc.1989-08-10
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (K894002)Baxter Healthcare Corp1989-08-10
EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM (K893956)Living Technology, Inc.1989-08-10
LATEX EXAMINATION GLOVES (K893299)Westmark Sps, Inc.1989-08-10
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 (K893760)Nova-Ventrx1989-08-10
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS (K894211)Sharplan Lasers, Inc.1989-08-10
SURGICARE (R) LATEX EXAMINATION GLOVES (K893651)Inter Continental Health Care1989-08-10
DERMATRON SKIN RESISTANCE METER (K883112)Raymar Electronics1989-08-10
PATIENT EXAMINATION GLOVES (K893161)Shanghai Shenchang Latex Products Factory1989-08-10
VECOM BRAND PATIENT EXAMINATION GLOVES (K892778)Koolsum Ent., Inc.1989-08-10
LATEX EXAMINATION GLOVES (K893592)Excel Glove Co., Ltd.1989-08-10
TECHNICON DPA-1 SYSTEM RF METHOD (K894574)Technicon Instruments Corp.1989-08-10
UROVIEW II (K893475)Oec-Diasonics, Inc.1989-08-10
EXAMINATION GLOVES (K890393)Sumirubber Industries (Kedah) Sdn. Bhd.1989-08-10
LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX) (K893694)Sinochem (Usa), Inc.1989-08-10
GENERAL SURGICAL INSTRUMENTS (K894670)Nopa Instruments1989-08-10
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS (K894210)Sharplan Lasers, Inc.1989-08-10
MODIFIED PATIENT EXAMINATION GLOVES (K894311)Safeskin Corp.1989-08-10
PATIENT EXAMINATION GLOVES (K893162)Guilin Fourth Latex Plant1989-08-10
EXAM GLOVES (MFG. SUZHOU XICHENG LATEX PRODUCTS) (K893156)China National Chemicals Import & Export (Liaoning1989-08-10
PATIENT EXAMINATION GLOVES (LATEX) (K891822)Kindly Assoc., Inc.1989-08-10
SURGICAL INSTRUMENT KIT, DISPOSABLE (K893814)Bioseal1989-08-10
PATIENT EXAMINATION GLOVES (LATEX) (K891635)Lucky Medsup, Inc.1989-08-10
SCANLISA HUMAN CRP ELISA KIT (K894573)Immuntech A/S1989-08-10
PATIENT EXAMINATION GLOVES (K893163)Nantong Ruchang Latex Products Co., Ltd.1989-08-10
PATIENT EXAMINATION GLOVES (LATEX) (K892032)Alizor, Inc. Dba Global Tech1989-08-10
PATIENT EXAMINATION GLOVES (LATEX) (K891701)Sonley Glove Mfg. , Ltd.1989-08-10
PENLON IDP PRESSURE FAILURE ALARM (K894689)Penlon, Inc.1989-08-10
LATEX EXAMINATION GLOVE (K890779)T.K. Glove Products Co., Ltd.1989-08-10
PATIENT EXAMINATION GLOVES (K893699)Marshall Latex Products Private , Ltd.1989-08-10
PATIENT EXAMINATION GLOVES DUBBLE BUTTERFLY (K892685)China National Chemical Construction Corp.-Qingdao1989-08-10
PATIENT EXAMINATION GLOVE (LATEX) (K892033)Weiss Ent., Inc.1989-08-10
PATIENT EXAM GLOVES (MFG. AMMATEX) (K892748)Dispomed, Inc.1989-08-10
OMNI-TRAK (PATIENT MONITOR) (K890817)Invivo Research, Inc.1989-08-10
PATIENT EXAMINATION GLOVE (LATEX) (K892013)Eastern Corp.1989-08-10
WELCON LIGHT HANDLE (K894397)Welcon, Inc.1989-08-10
B.T.C. PATIENT EXAMINATION GLOVES (K892939)B. Tang Chuan Co. , Ltd.1989-08-10
SURGITEK FLAT T-SPAN (K884746)Medical Engineering Corp.1989-08-10
EMAS GLOVE (K893724)Exim Mfg. & Assoc. Services, Sdn Bhd1989-08-10
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (K892060)Syva Co.1989-08-10
STERILE PATIENT EXAMINATION GLOVES (K892946)Yeou-Fwu Rubber Industrial Co., Ltd.1989-08-10
AMMEL STERILE SURGEON'S GLOVES (K894501)Mauricio Menconi1989-08-10
SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX (K894066)Sharplan Lasers, Inc.1989-08-10
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE (K893126)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-10
ZIMMER TENS (K894388)American Imex1989-08-10
VARIAN MULTILEAF COLLIMATOR (K893464)Varian Assoc., Inc.1989-08-10
POWDER FREE VINYL EXAMINATION GLOVES (K893883)Libent Co., Ltd.1989-08-10
LATEX EXAMINATION GLOVES (K891445)Superior Healthcare Group, Inc.1989-08-09
B-D PATIENT EXAMINATION GLOVES (K894280)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-09
CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER (K893832)Heraeus Lasersonics, Inc.1989-08-09
PATIENT EXAMINATION GLOVE (LATEX) (K891114)Ambusco Co., Inc.1989-08-09
PATIENT EXAMINATION GLOVES (VINYL) (K892607)Disposable Products Co.1989-08-09
PATIENT EXAMINATION GLOVE (VINYL) (K892565)Kao Ying Industrial Co., Ltd.1989-08-09
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD (K885179)Baxter Healthcare Corp1989-08-09
MRT-50A MOBILE (K893750)Toshiba Medical Systems1989-08-09
INTERMEDICS APR(TM) II FEMORAL COMPONENT (K890450)Intermedics Orthopedics1989-08-09
SHIELDTEX PATIENT EXAMINATION GLOVE (LATEX) (K891263)Dah Giap Rubber Industries Sdn Bhd1989-08-09
PATIENT EXAMINATION GLOVES (LATEX) (K891499)Promedica Sdn. Bhd.1989-08-09
PATIENT EXAMINATION GLOVES (LATEX) (K892472)Malatex Industries Sdn. Bhd.1989-08-09
PATIENT EXAMINATION GLOVES (LATEX) (K892136)Beijing Light Industrial Products Import & Export1989-08-09
LATEX EXAM GLOVES (MFG. GLOVELINE INDUSTRIES) (K893277)China Representatives , Ltd.1989-08-09
ARC-2F ACETABULAR CUP (K893785)Protek, Inc.1989-08-09
B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) (K894602)Beacon Laboratories, Inc.1989-08-09
ORTHODERM CONVERTIBLE (K894353)Health Products, Inc.1989-08-09
INTRASITE* GEL (3) YEAR SHELF LIFE (K891870)Smith & Nephew United, Inc.1989-08-09
VISULIN TRANSPARENT ADHESIVE DRESSING (K894147)James River Corp.1989-08-09
LATEX EXAMINATION GLOVES (K894306)Ttj Industrial Co. , Ltd.1989-08-09
USCI CORONARY INFUSION CATHETER (K891069)C.R. Bard, Inc.1989-08-09
PATIENT EXAMINATION GLOVES (K893267)Hubei Provincial Medicines & Health Products Impor1989-08-09
FLEXGARD SYRINGE PROTECTOR (K893862)Dr. Gil Del Castillo1989-08-09
PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER (K893644)Perkins Mfg. Co.1989-08-09
PATIENT EXAMINATION GLOVES (LATEX) (K892148)Setia Aircon Sdn. Bhd.1989-08-09
KRR GLOVE, PATIENT EXAMINATION GLOVES (K894452)Kerala Rubber & Reclaims, Ltd.1989-08-09
DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES (K891819)Adler Industries, Inc.1989-08-09
UNICATH A (K892849)Xre Corp.1989-08-09
PATIENT EXAMINATION GLOVE (K891619)Union Rubber Gloves Co., Ltd.1989-08-09
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY (K894430)Daig Corp.1989-08-09
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A (K892354)Hewlett-Packard Co.1989-08-08
FD 400 DENTAL STOOL (K893946)Oriola OY Finndent1989-08-08
GLASS MERCURY FILLED THERMOMETERS (K893602)Smith & Nephew United, Inc.1989-08-08
EXTENDED COVERS, STERILE (K892069)Amedic USA1989-08-08
GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE (K892071)Amedic USA1989-08-08
ASTRO BEHIND-THE-EAR HEARING AID (K892898)Rexton, Inc.1989-08-08
THE PUDENZ IN LINE VALVE (K894072)Baxter Healthcare Corp1989-08-07
OXYGEN THERAPY REGULATOR (K894302)Modern Engineering Co., Inc.1989-08-07
GAS-VAK(R), MODEL 300 (K890438)Gas-Vak1989-08-07
MATRX DENTAL UNIT (K893219)Matrix Medica, Inc.1989-08-07
RESUBMITTED STC SERIES 8600 AUTOCLAVE (K890359)Sterilizer Technologies Corp.1989-08-07
PREEMICARE SERIES 2000 INFANT WARMER (K885350)Preemicare Corp.1989-08-07
LATEX EXAMINATION GLOVES (K894014)Hsin Hung Co. , Ltd.1989-08-07
#157 EXAM LIGHT (K893949)Medmark, Inc.1989-08-07
CARDIAC COMPUTATION SOFTWARE PACKAGE (K890636)Elscint, Inc.1989-08-07
C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR (K890757)Spsmedical Supply Corp.1989-08-07
STRIP, STERILIZATION INDICATOR, E.O. GAS (K890760)Spsmedical Supply Corp.1989-08-07
HOOD PEDIATRIC TRACHEOSTOMY TUBE (K893866)Hood Laboratories1989-08-07
SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER (K894396)Surgilase, Inc.1989-08-07
LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GAS (K890763)Spsmedical Supply Corp.1989-08-07
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Track 1989 automatically

Every clearance here is in the API, with alerts when new ones post.