Atlas FDA

1989

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

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RecordFirmDate
HORIZON CENTRAL STATION (K892066)Mennen Medical, Inc.1989-06-22
HPI NON STERILE EXAM GLOVES (K893018)Tillotson Corp.1989-06-22
BP-8800 BLOOD PRESSURE MONITOR (K890876)Colin Medical Instruments Corp.1989-06-22
FIBEROPTIC HEADLIGHT SYSTEM (K893458)Cuda Products Co.1989-06-22
TRU-TOUCH VINYL EXAM GLOVES (CANADA) (K891952)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-06-22
PATIENT EXAM GLOVES (MFG. NINGBO MEDICAL LATEX) (K892152)Sinochem (Usa), Inc.1989-06-22
CUFF SPECULUM (K893531)Mountain Medical Equipment, Inc.1989-06-22
PURAFLEX PATIENT EXAMINATION GLOVES (K892017)Medsi, Inc.1989-06-22
NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS (K892204)Nidek, Inc.1989-06-22
FORCEPS, SURGICAL, GYNECOLOGICAL (K892820)The South India Surgical Co. Pvt. , Ltd.1989-06-22
HUGH YOUNG II UROLOGICAL TABLE (K891403)Mallinckrodt Group, Inc.1989-06-22
FLUIDIZED AIR BED (K893708)Gsi Development Co.1989-06-22
SINGLE USE VINYL EXAM GLOVES - COLOR CODED (K892976)Phoenix Medical Technology, Inc.1989-06-22
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS (K892937)Dentsply Intl.1989-06-22
PATIENT EXAMINATION GLOVES (K892480)Foodhandler, Inc.1989-06-21
LATEX SURGICAL GLOVES (K893340)Kenmark Industrial Co., Ltd.1989-06-21
BACTON TM, BASIC TM, APO B REAGENT (K893884)Catachem, Inc.1989-06-21
SLT CONTACT LASER SYSTEM (K893701)Surgical Laser Technologies, Inc.1989-06-21
PATIENT EXAMINATION GLOVES (LATEX) (K892309)Min an Chemical Industrial Co., Ltd.1989-06-21
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (K892213)Analytical Control Systems, Inc.1989-06-21
SANITARY NAPKIN PADS (K890125)Landen Corp.1989-06-21
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. (K890864)Rastronics USA, Inc.1989-06-21
CANNULATED BIOPSY FORCEPS (K892687)Zinnanti Surgical Instruments, Inc.1989-06-21
DELTA (TM) ROBOTIC PIPETTOR (K893031)Diagnostic Products Corp.1989-06-21
PHARMA-PLAST INSULIN INFUSION SET (K884978)Pharma-Plast USA, Inc.1989-06-21
SHARPLAN 1075 CO2 LASER (K893206)Sharplan Lasers, Inc.1989-06-21
PATIENT EXAMINATION GLOVES (K890930)Thaima Products Co., Ltd.1989-06-21
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE (K893255)American Orthodontics1989-06-21
BACTON TM, BASIC TM, APO A-I REAGENT (K893885)Catachem, Inc.1989-06-21
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION (K892915)Deknatel, Inc.1989-06-21
PATIENT EXAMINATION GLOVES (LATEX) (K892506)Universal Latex Products Co., Ltd.1989-06-21
MP TEST (K882596)Diatech Diagnostica , Ltd.1989-06-21
HSV-2 ELISA TEST SYSTEM (K891782)Zeus Scientific, Inc.1989-06-20
ARGENCO 30 TYPE IV DENTAL GOLD ALLOY (K893564)Argen Precious Metals, Inc.1989-06-20
VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM (K890047)Vascucare, Inc.1989-06-20
EBNA-CHECK(TM) TEST KIT (K891542)Diagnostic Technology, Inc.1989-06-20
AST REAGENT (PROCEDURE NUMBER 158) (K892844)Sigma Chemical Co.1989-06-20
DR. VOLKNER'S LAMELLAR TURNING BED(TM) (K891457)James Consolidated, Inc.1989-06-20
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) (K892227)Edentec Corp.1989-06-20
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE (K893633)Medtronic Vascular1989-06-20
PACEMAKER LEAD ADAPTER (K890018)Ela Medical, Inc.1989-06-20
SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE (K890926)Meadox Surgimed, Inc.1989-06-20
GUIDE WIRE INTRODUCER (K890807)Datascope Corp.1989-06-20
L30-LB- INFANT LIMB BAND (K893245)Contour Electrodes, Inc.1989-06-20
SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 (K892005)Physio-Control Corp.1989-06-20
ENZYMATIC UREA NITROGEN REAGENT SET (K892331)American Monitor Corp.1989-06-20
ARGENCO 52 TYPE IV DENTAL GOLD ALLOY (K893567)Argen Precious Metals, Inc.1989-06-20
HSV-1 ELISA TEST SYSTEM (K891162)Zeus Scientific, Inc.1989-06-20
PERIFLUX PF3 (K890828)Perimed, Inc.1989-06-20
ARGENCO 42 TYPE IV DENTAL GOLD ALLOY (K893563)Argen Precious Metals, Inc.1989-06-20
HSV-CHECK(TM) TEST KIT (K890819)Diagnostic Technology, Inc.1989-06-20
RESUBMITTED EBV/IGM-CHECK TEST KIT (K890639)Diagnostic Technology, Inc.1989-06-20
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 (K893224)Helena Laboratories1989-06-20
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER (K893392)Baxter Healthcare Corp1989-06-20
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY (K893605)Serono-Baker Diagnostics, Inc.1989-06-20
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM (K893423)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-06-20
IL1400, BGELECTROLYTE ANALYZER (K890827)Instrumentation Laboratory CO1989-06-20
INTRA AORTIC BALLOON (K893243)Datascope Corp.1989-06-20
REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (K892818)Helena Laboratories1989-06-20
USCI GREY/BLACK GUIDE WIRE (K890505)C.R. Bard, Inc.1989-06-20
ARGENCO 60 TYPE IV DENTAL GOLD ALLOY (K893554)Argen Precious Metals, Inc.1989-06-20
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER (K890794)Daig Corp.1989-06-20
AMRESCO PRODUCT NUMBER 7426 (K891923)American Research Products Co.1989-06-20
LATEX EXAMINATION GLOVES (K893268)Regulus Intl. Corp.1989-06-19
LOW POWDER SINGLE USE LATEX EXAM GLOVES (K892975)Phoenix Medical Technology, Inc.1989-06-19
WARDEN LATEX EXAMINATION GLOVES (K893179)Kuo Jun Ent. Co., Ltd.1989-06-19
PATIENT EXAMIAINATION GLOVES (LATEX) (K892247)Jiann FA Rubber Factory Co., Ltd.1989-06-19
BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (K892654)Princeton Biomedix1989-06-19
CHOLESTEROL REAGENT SET (K893479)American Monitor Corp.1989-06-19
CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES (K893107)Winmed Instruments Mfg. Corp.1989-06-19
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. (K892905)Catachem, Inc.1989-06-19
THE ROYAL GLOVES (PATIENT EXAM GLOVES) (K891958)Taizhu Latex Glove Factory , Ltd.1989-06-19
PATIENT EXAMINATION GLOVES (LATEX) (K891374)M.R.G. Industries Sdn. Bhd.1989-06-19
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 (K891912)American Research Products Co.1989-06-19
LATEX EXAMINATION GLOVES (K893015)Universal Gloves Private , Ltd.1989-06-19
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 (K893211)Helena Laboratories1989-06-19
QUALITEX LATEX EXAMINATION GLOVES (K892414)Agri-Bag Corp.1989-06-19
PATIENT EXAMINATION GLOVES (LATEX) (K892471)Tabri Gloves Sdn. Bhd.1989-06-19
PATIENT EXAMINATION GLOVES (LATEX) (K891702)Thai Nam Rubber Gloves Co., Ltd.1989-06-19
SAMBORD LATEX PATIENT EXAMINATION GLOVES (K891644)Polymint Industrial Co. , Ltd.1989-06-19
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST (K893737)Quidel Corp.1989-06-16
VIS-DISK HCG (EIA) JPL-041M (K891096)Leeco Diagnostics, Inc.1989-06-16
OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL (K884884)Porex Technologies Corp. of Georgia1989-06-16
JESBERG ESOPHAGOSCOPE (K892259)Zinnanti Surgical Instruments, Inc.1989-06-16
THE TONGUE CLEANER (K892388)Rajiv R. Shah1989-06-16
IMPLANT PARALLELING DEVICE (I.P.D.) (K890433)J.E. Josephson, D.M.D.1989-06-16
THE SMILE MACHINE (K891694)Brilliant Industries, Inc.1989-06-16
MAX-1 (EXERCISE ELECTROCARDIOGRAPH) (K890323)Marquette Electronics, Inc.1989-06-16
ALPHA MODEL I ITE HEARING AID (K890271)Alpha Instruments, Inc.1989-06-16
MICROTRAK EIA AUTOREADER (K891270)Syva Co.1989-06-16
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE (K892001)Dexide, Inc.1989-06-16
STERILE IRRIGATION TRAYS (K890728)Cypress Medical Products, Ltd.1989-06-16
PRIMUS MODEL CLC 330 (K891235)Primus, Inc.1989-06-16
BECKMAN EPSILON(TM) IGE REAGENT KIT (K893125)Beckman Instruments, Inc.1989-06-16
AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL (K881196)Biometer Intl. A/S1989-06-16
SPIRO-LINK REAL TIME SPIROMETRY SYSTEM (K892121)Biocom Intl., Inc.1989-06-16
THE CEN-SLIDE(TM) CENTRIFUGE TUBE (K891604)Davstar California, Inc.1989-06-16
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 (K891922)American Research Products Co.1989-06-16
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST (K893117)Bayer Corp.1989-06-16
KULZER INLAY SYSTEM (K892454)Kulzer, Inc.1989-06-16
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Track 1989 automatically

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