Atlas FDA

1989

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

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RecordFirmDate
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 (K894482)Em Diagnostic Systems, Inc.1989-09-07
ACCESS TM (K894290)Diasonics, Inc.1989-09-07
PATIENT EXAMINATION GLOVES (LATEX) (K892622)Latexon Co., Ltd.1989-09-07
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM (K893811)Sakura Finetek U.S.A., Inc.1989-09-07
FABFOAM #302 (K894683)Jewell Industries1989-09-07
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB (K894838)Baxter Healthcare Corp1989-09-07
GLUCOSE-HK TEST (GLU-HK) ITEM #65415 (K894483)Em Diagnostic Systems, Inc.1989-09-07
ESSE QUATTRO/ESSE UNO (K894060)Eurodent, Inc.1989-09-07
ACUDATA INDICATENS MODEL 5M (K890087)Acudata Software1989-09-07
DSL 17A-OH PROGERSTERONE (DSL #6800) (K894265)Diagnostic Systems Laboratories, Inc.1989-09-07
MODIFIED PRISTINE CULTURE CATHETER (K893390)Hml Medical, Inc.1989-09-07
ISOLIGHT (K894059)Eurodent, Inc.1989-09-07
STERLING TENS (K891118)Armstrong Industries, Inc.1989-09-06
CORRECT TOUCH SURGEONS GLOVES (K892176)Ampri Rubberware Industries Sdn Bhd1989-09-06
HAEMOPHILUS TEST MEDIUM (BROTH) (K894848)Regional Media Laboratories1989-09-06
STERILE LATEX SURGICAL GLOVES (K893899)Life Force Laboratories, Inc.1989-09-06
ARVEE APNEA MONITOR, MODEL 2400 (K891676)Arvee Medical, Inc.1989-09-06
STERILE SURGICAL NATURAL LATEX GLOVES (K891622)Ct Intl.1989-09-06
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER (K894431)Daig Corp.1989-09-06
SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT (K890913)Shimadzu Precision Instruments, Inc.1989-09-06
LUMISCOPE MODEL 1000/APCC MODEL 1000 (K894127)Lumiscope Co., Inc.1989-09-06
ARBO H79P DISPOSABLE MONITORING ELECTRODES (K894562)Arbo Medical, Inc.1989-09-05
SENTRY LATEX EXAMINATION GLOVES (K894849)Vijayshree Spinning Mills , Ltd.1989-09-05
PATIENT EXAMINATION GLOVES (LATEX) (K892081)Tacare Products , Ltd.1989-09-05
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER (K893963)V.S.B.B. Technologies, Inc.1989-09-05
APACERAM ARTIFICIAL DENTAL IMPLANT (K885133)Asahi Optical Co. C/O Rosati Associates, P.C.1989-09-05
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL (K894148)Howmedica Corp.1989-09-05
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT (K894173)Catachem, Inc.1989-09-05
PATIENT EXAMINATION GLOVES (K894003)Beekay Hygiene Products1989-09-05
LATEXCO LATEX EXAMINATION GLOVES (K891265)Latex Products Co., Inc.1989-09-05
ABBOTT TESTPACK PLUS HCG URINE (K894408)Abbott Laboratories1989-09-05
LANDSCAPE PATIENT EXAMINATION GLOVES (K893049)Pacific Intl. Economic & Technical, Inc. U.S.A.1989-09-05
MASCOT LAB SPONGE (K894984)Mascot, Inc.1989-09-05
GEMTAB SYSTEM (K894503)Pharmacia Eni Diagnostics, Inc.1989-09-05
ROCHE REAGENT FOR URIC ACID (K894101)Roche Diagnostic Systems, Inc.1989-09-05
PATIENT EXAMINATION GLOVES (LATEX) (K892080)The Orient Connection1989-09-05
#556 DISPOSABLE UMBILICAL CORD CLAMP (2) (K894646)Alpha Unlimited, Inc.1989-09-05
STEALTH DILATION CATHETER SYSTEM (K893411)Target Therapeutics1989-09-05
E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE (K894960)E.Z. Lock, Inc.1989-09-05
CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS (K894359)Hemotec, Inc.1989-09-05
CALCIUM TEST ITEM NUMBER: 65409 (K893778)Em Diagnostic Systems, Inc.1989-09-05
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. (K894317)Hemotec, Inc.1989-09-05
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS (K894146)Baxter Healthcare Corp1989-09-05
MODEL #520/525 ED/RECOVERY STRETCHER (K894987)Medmark, Inc.1989-09-05
ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER (K890687)Optimed, Inc.1989-09-05
STAT-PAD (K894926)Hettel Accessories, Inc.1989-09-05
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL (K894329)Amersham Corp.1989-09-05
THROMBIN TIME REAGENT (K894467)Sigma Chemical Co.1989-09-05
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS (K894466)Hemotec, Inc.1989-09-05
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 (K894718)Intermedics, Inc.1989-09-05
ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO (K894648)Arbo Medical, Inc.1989-09-05
BARD CATH LAB THERMODILUTION CATHETER (K893474)C.R. Bard, Inc.1989-09-05
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM (K893216)Radiation Measurements, Inc.1989-09-05
NON-STERILE VINYL EXAMINATION GLOVES (K892994)Sian-Yu Industrial Co., Ltd.1989-09-05
OXIMETER (K893587)Radiometer America, Inc.1989-09-05
MYOCARDIAL PROBE THERMOMETER CODE 64000 (K893418)Dlp, Inc.1989-09-05
GENERAL IVT NEEDLE GUIDE KIT, STERILE (K892070)Amedic USA1989-09-05
EMIT T-UPTAKE ASSAY (K894145)Syva Co.1989-09-05
MOBILE X-RAY UNIT (K894021)Ziehm International, Inc.1989-09-01
MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL (K883566)Minnetonka, Inc.1989-09-01
FPR TOBRAMYCIN KIT (K894531)Colony Laboratories, Inc.1989-09-01
MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL (K883619)Minnetonka, Inc.1989-09-01
PATIENT EXAMINATION GLOVES (LATEX) (K892020)Asset Ent., Sdn Bhd1989-09-01
PATIENT EXAMINATION GLOVES (LATEX) (K892084)Mirano Sdn. Bhd.1989-09-01
FPR TOBRAMYCIN CALIBRATOR KIT (K894532)Colony Laboratories, Inc.1989-09-01
SURGIMAX PATIENT EXAM GLOVES (LATEX) (K891744)Excel Rubber Products (M) Sdn. Bhd.1989-09-01
AMBI-DEX (LATEX EXAMINATION GLOVES) (K890115)Globe Safety Products, Inc.1989-09-01
PATIENT EXAMINATION GLOVES (K893595)Arcofield , Ltd.1989-09-01
OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60 (K891173)Ceramed Corp.1989-09-01
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) (K885069)Richards Medical Co., Inc.1989-09-01
CASS SYSTEM (K894263)Medical Instrumentation & Diagnostics Corp.(Midco)1989-09-01
PATIENT EXAMINATION GLOVES (LATEX) (K892072)Gaw Rubber Products Sdn. Bhd.1989-09-01
PATIENT EXAM GLOVES (MFG. SHANGHAI LATEX FACTORY) (K892181)Grand Monde Trading Co., Inc.1989-09-01
SHIH KUO LATEX EXAM GLOVE (K892083)Beverly Ent., Inc.1989-09-01
MEDISYS RECORD AND VERIFY SYSTEM (K893978)Medisys, Inc.1989-09-01
LATEX EXAMINATION GLOVES (K893591)Shanghai Medicines & Health Products Import & Expo1989-09-01
CHAMP-PAQ VINYL PATIENT EXAM GLOVES (K892079)Winmed Instruments Mfg. Corp.1989-09-01
PATIENT EXAMINATION GLOVES (LATEX) (K891831)Pai Hoi Ent., Ltd.1989-09-01
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM (K890472)Kinamed, Inc.1989-09-01
PATIENT EXAMINATION GLOVES (LATEX) (K892485)Intl. Pacific Industrial Corp. (Usa), Inc.1989-09-01
BIO-VENT (K883717)Core-Vent Corp.1989-09-01
CT HILIGHT ADVANTAGE (K894269)GE Medical Systems1989-09-01
HYPAFIX DRESSING RETENTION SHEET (K894254)Smith & Nephew United, Inc.1989-08-31
LATEX EXAMINATION GLOVES (K893450)Ken FA Latex Products Corp.1989-08-31
PATIENT EXAMINATION GLOVES (LATEX) (K894022)Baxter Healthcare Corp1989-08-31
PATIENT EXAMINATION GLOVES (LATEX) (K891731)Southern Medical Products, Inc.1989-08-31
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 (K893915)Em Diagnostic Systems, Inc.1989-08-31
PHOSPHORUS TEST ITEM NUMBER 65416 (K894288)Em Diagnostic Systems, Inc.1989-08-31
DISPOSABLE NON STERILE LATEX EXAM GLOVES (K890905)Harvest Intl. of America, Inc.1989-08-31
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 (K891674)Preemicare Corp.1989-08-31
PATIENT EXAMINATION GLOVES (VINYL) (K894023)Baxter Healthcare Corp1989-08-31
LATEX NON-STERILE PATIENT EXAMINATION GLOVES (K892973)Polikon Trading Co.1989-08-31
EVAC-TUBE (K894032)Sharn, Inc.1989-08-31
PATIENT EXAMINATION GLOVES (LATEX) (K891724)United Lion Rubber Industries Sdn. Bhd.1989-08-31
BIOCHEM 8100 ANESTHETIC AGENT MONITOR (K892646)Biochem International, Inc.1989-08-31
SOFCARE PATIENT EXAMINATION GLOVES (LATEX) (K891965)P. T. Tata Rubberindo Industries1989-08-31
DYNATECH MR 5000, CATALOG #011-976-0600 (K894687)Dynatech Laboratories, Inc.1989-08-31
BION EBV-G (VCA) TEST SYSTEM (K891785)Bion Ent., Ltd.1989-08-31
SENSITITRE INDOLE REAGENT (K894776)Radiometer America, Inc.1989-08-31
8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI (K894850)Modern Engineering Co., Inc.1989-08-31
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