Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CARDIOBEEPER II (K883843)Survival Technology, Inc.1988-11-09
OEC-7102 ECG/NIBP MONITOR (K882254)Nihon Kohden America, Inc.1988-11-09
KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S (K883215)Kirschner Medical Corp.1988-11-09
MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A (K883973)Nihon Kohden America, Inc.1988-11-09
SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY (K883930)Seamed Corp.1988-11-09
CONCEPT POWER SYSTEM (K881954)Concept, Inc.1988-11-09
SENSOCOR(TM) R-TEST 240 XL (K881772)Sensormedix, Inc.1988-11-09
ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR (K882635)Nihon Seimitsu Sokki Co., Ltd.1988-11-09
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY (K883304)Cardiotronics, Inc.1988-11-09
KORBER ARTERIOTOMY SCISSORS (K884373)Micrins, Ltd.1988-11-08
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (K884255)Concept, Inc.1988-11-08
VKG 1000, VIDEO KERATOMETER (K883471)Technitex, Inc.1988-11-08
SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) (K884196)Disposable Sterile Surgical Instruments, Inc.1988-11-08
ALCON FLUID INJECTOR (K882723)Alcon Laboratories1988-11-08
BED SHEET, PILLOW CASE (K884380)Saybrex Intl., Inc.1988-11-08
RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS (K884435)Clinical Connections, Inc.1988-11-08
ENVIROTENT (BED) (K881725)Envirotents, Inc.1988-11-08
SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE (K884295)Saybrex Intl., Inc.1988-11-08
BIOSEARCH 3600 ENTRI FEEDING PUMP (K883587)Biosearch Medical Products, Inc.1988-11-08
DIMENSION WHOLE BLOOD CHOLESTEROL (K880723)Technimed, Inc.1988-11-08
HERNIASTAT (K884404)Innovative Surgical Devices Corp.1988-11-08
STERILE SURGICAL LATEX GLOVES (K882715)Plastic Materials of Puerto Rico, Inc.1988-11-08
LUM VASCULAR PROCEDURE SYSTEM #B5200A (K883664)General Electric Co.1988-11-07
OPTIMED ADVANTAGE (K883458)Optimed, Inc.1988-11-07
CRITICAL CARE I.V. STAND STABILIZING BRACKET (K884341)Rbd Medical, Inc.1988-11-07
DITTMAR POWER LIFTER (K883260)Dittmar and Penn Corp.1988-11-07
CMS IV EXTENSION SETS (K884370)Churchill Medical Systems, Inc.1988-11-07
ERGO II, SURGICAL LATEX GLOVES (K884030)Ergo Intl., Ent., Inc.1988-11-07
THERMOMETER, MERCURY/CLINICAL (K883573)Umax Corp.1988-11-07
STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY (K882875)Lorad Medical Systems, Inc.1988-11-07
REUSABLE ADULT INCONTINENT DIAPER (K883787)Intera Corp.1988-11-07
IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER (K882138)Imex Medical Systems, Inc.1988-11-07
METALASER VASCULASE (K883541)Metatech Corp.1988-11-04
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (K884217)Technicon Instruments Corp.1988-11-04
FORCE GUARD I (K882974)Boulder Impact Monitors, Inc.1988-11-04
MEDITEC QL-15 ND:YAG LASER (K884060)Storz Ophthalmics, Inc.1988-11-04
OLV 1100; OLV 1200 PULSE OXIMETERS (K881307)Nihon Kohden America, Inc.1988-11-04
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES (K883923)Gish Biomedical, Inc.1988-11-04
NIOBI-X RADIATION REDUCTION FILTER (K882939)American Canadian Products, Inc.1988-11-04
PORT-O-HEAT, MODEL 0100 (K882151)Arthotronics, Inc.1988-11-04
HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE (K883481)Hewlett-Packard Co.1988-11-04
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY (K883722)Ciba Corning Diagnostics Corp.1988-11-04
CORONARY GUIDE WIRE (K883579)Datascope Corp.1988-11-04
ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) (K884400)Immco Diagnostics, Inc.1988-11-04
MEDRAD OMNIPLANE 300 SYSTEM (K883834)Medrad, Inc.1988-11-04
ICOR AGENT MONITOR (K883532)Icor AB1988-11-04
TITANIUM GREENFIELD VENA CAVA FILTER CARRIER (K874096)Medi-Tech, Inc.1988-11-04
QM300 CONTROL E (K883537)Kallestad Diag, A Div. of Erbamont, Inc.1988-11-04
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES (K883564)Advanced Cardiovascular Systems, Inc.1988-11-03
CAPD DISPOSABLE Y SYSTEM - DY SET (K883393)Medionics International , Ltd.1988-11-03
PREMIER DECANNULATION STOPPER (K884015)Premier Dental1988-11-03
NOVAPATH SPECIMEN COLLECTION KIT (K884342)Bio-Rad1988-11-03
VARITEST (K882547)Eureka AB1988-11-03
CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY (K882271)Nuccardiac Software, Inc.1988-11-03
SYMBION CENTRIFUGAL BLOOD PUMP MODEL I (K882129)Symbion, Inc.1988-11-03
GUIDING CATHETER (TIP SOFTNESS CHANGE) (K883981)Devices For Vascular Intervention, Inc.1988-11-03
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) (K883603)3M Health Care, Sarns1988-11-03
COHERENT EXCELITE CO2 AIR FIBER (K884204)Coherent Medical Lasers1988-11-03
PREDICTOR II SIGNAL AVERAGING ECG (K883855)Corazonix Corp.1988-11-03
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (K884298)Atlantic Antibodies1988-11-02
HEALTH-WATCH BED MONITOR (K882377)Engineering Developments, Co.1988-11-02
MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT. (K882352)Clinical Information Systems, Inc.1988-11-02
CO2 SURGICAL LASER SYSTEM MODEL #IR105 (K882951)Niic U.S.A., Inc.1988-11-02
TS1000 SUCTION TIP (K883384)M.D. Engineering, Inc.1988-11-02
CO2 SURGICAL LASER SYSTEM MODEL #IR106 (K882952)Niic U.S.A., Inc.1988-11-02
OXYTROL (K883590)Cryogenic Assoc.1988-11-02
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. (K884427)Bivona Medical Technologies1988-11-02
MARK-5 CONCENTRATOR (K883591)Nidek Medical Products, Inc.1988-11-02
ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE (K880639)Human Technologies, Inc.1988-11-02
SPQ(TM) TEST SYSTEM FOR PREALBUMIN (K884297)Atlantic Antibodies1988-11-02
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA (K884119)S & W Medico Teknik1988-11-02
MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74 (K881960)Med Service, Inc.1988-11-01
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 (K880868)Diagnostic Chemicals, Ltd. (Usa)1988-11-01
IRRIGATION SET (K883300)Edwards Orthopaedics Div., Baxter Healthcare Corp.1988-11-01
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 (K884307)Y1988-11-01
TYMPANIC TEMPERATURE SCANNER (K882949)Omega Medical Corp.1988-11-01
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES (K883747)Diagnostic Products Corp.1988-11-01
SONY COLOR VIDEO CAMERAS AND ACCESSORIES (K884343)Sony Corp. of America1988-11-01
250 ML BAG W/Y INJECT. & 12 EXTENSION SET (K882598)Prn Services, Inc.1988-11-01
MODIFIED LANDMARK VENOUS ACCESS DEVICE (K884259)Menlo Care, Inc.1988-11-01
ORTHO FACTOR XII DEFICIENT PLASMA (K883688)Ortho Diagnostic Systems, Inc.1988-11-01
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) (K883878)Amersham Corp.1988-11-01
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (K884357)Precision Dynamics Corp.1988-11-01
ORTHO OWREN'S BUFFER (K883689)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR XI DEFICIENT PLASMA (K883691)Ortho Diagnostic Systems, Inc.1988-11-01
OMNISOUND(TM) 3000 (K883893)Physio Technology, Inc.1988-11-01
MSI STANDARD BED MODELS: L1097-64 AND L1085-64 (K881961)Med Service, Inc.1988-11-01
Q4000 OPTION FOR Q4000 (K882978)Quinton, Inc.1988-11-01
EP-100 INFUSION PUMP (K883653)Stereotactic Medical Systems, Inc.1988-11-01
ORTHO FACTOR X DEFICIENT PLASMA (K883690)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR VII DEFICIENT PLASMA (K883692)Ortho Diagnostic Systems, Inc.1988-11-01
NATURALYTE MIXER (K883408)National Medical Care, Medical Products Div., Inc.1988-10-31
FIAGEN RUBELLA IGG (K883182)Cyberfluor, Inc.1988-10-31
ANALYST THEOPHYLLINE ROTOR (K884002)The DU Pont Co.1988-10-31
COE PAK AUTO MIX, REGULAR OR HARD SET (K881422)Coe Laboratories, Inc.1988-10-31
DERATA MEDI-JECTOR V (K883847)Derata Corp.1988-10-31
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER (K883539)Serono-Baker Diagnostics, Inc.1988-10-31
KD 0.1 M SODIUM CITRATE SOLUTION (K883635)King Diagnostics, Inc.1988-10-31
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) (K883267)Diagnostic Products Corp.1988-10-31
KD 0.02 M CALCIUM CHLORIDE SOLUTION (K883637)King Diagnostics, Inc.1988-10-31
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