Atlas FDA

1988

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

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RecordFirmDate
FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER (K881494)Biophysic Medical, Inc.1988-08-30
SYNTHETIC CAST TAPE (K883294)Carapace, Inc.1988-08-30
VISTA INSTRUMENT (K882914)Abbott Laboratories1988-08-30
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) (K880886)Immuno Concepts, Inc.1988-08-30
NORMAL HUMERAL PROSTHESIS (K881750)Osteonics Corp.1988-08-30
ANOTRON(R) INCONTINENCE CONTROL SYSTEM (K882555)Biosonics, Inc.1988-08-30
MODEL #918 MULTI-PADS (K883375)Cardiotronics, Inc.1988-08-30
L.P.I. LASER DELIVERY SYSTEM (K882738)Laser Photonics, Inc.1988-08-30
FIAGEN HGH FLUOROIMMUNOASSAY KIT (K882823)Cyberfluor, Inc.1988-08-30
DU PONT EBNA-IGG ANTIBODY ELISA KIT (K875203)E.I. Dupont DE Nemours & Co., Inc.1988-08-30
SFRE 199-1 MEDIUM, CATALOG NO. 200-2191 (K883451)J R Scientific1988-08-30
PMT SUBARACHNOID SCREW, MODEL NO.1350-2 (K883115)Pmt Corp.1988-08-29
L-15 MEDIUM, CATALOG NO. 200-2021 (K883362)J R Scientific1988-08-29
EXAKT CUTTING & GRINDING SYSTEM (K883514)Exakt Medical Instruments, Inc.1988-08-29
L-15 MEDIUM, CATALOG NO. 210-4004 (K883369)J R Scientific1988-08-29
VITALOGRAPH-ALPHA (K873562)Vitalograph , Ltd.1988-08-29
INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP (K881836)Intermedics Orthopedics1988-08-29
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A (K881013)Toshiba Medical Systems1988-08-29
LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD (K881868)Supelco, Inc.1988-08-29
FISCHER'S MEDIUM CATALOG NO. 210-4007 (K883370)J R Scientific1988-08-29
PHARMACIA CHLAMYDIA EIA (K882676)Pharmacia, Inc.1988-08-29
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105 (K883363)J R Scientific1988-08-29
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505 (K883364)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048 (K883449)J R Scientific1988-08-29
SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN (K882909)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-29
CALF SERUM, CATALOG NO. 110-1125 (K883367)J R Scientific1988-08-29
HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012 (K883445)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517 (K883496)J R Scientific1988-08-29
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT (K881015)Pacific Biotech, Inc.1988-08-29
MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531) (K883501)J R Scientific1988-08-29
FETAL BOVINE SERUM, DEFINED NO. 110-1121 (K883502)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046 (K883448)J R Scientific1988-08-29
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS (K882313)Syva Co.1988-08-29
FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123 (K883498)J R Scientific1988-08-29
EMIT QST CARBAMAZEPINE ASSAY (K882961)Syva Co.1988-08-29
FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122 (K883446)J R Scientific1988-08-29
SERIES I AND II IMPLANTS (K882226)Saber Technology, Inc.1988-08-29
MEDIUM 199, 10X CATALOG NO. 210-3556 (K883497)J R Scientific1988-08-29
HORSE SERUM, ABATTOIR, NO. 110-1112 (K883365)J R Scientific1988-08-29
MEDIUM 199, 10X, CATALOG NO. 210-3557 (K883499)J R Scientific1988-08-29
LAD MODEL 633 LUMINOMETER (K882608)Los Alamos Diagnostics1988-08-29
RAICHEM(TM) BILIRUBIN STANDARD (K882726)Reagents Applications, Inc.1988-08-29
DADE(R) CK-MB IMMUNOASSAY CONTROL (K882795)Baxter Healthcare Corp1988-08-29
BIOPRO PC FEMORAL HIP COMPONENT (K882146)Biopro, Inc.1988-08-29
RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. (K882801)Hf Scientific, Inc.1988-08-29
MCCOY'S 5A MEDIUM 10X NO. 210-3532 (K883500)J R Scientific1988-08-29
TEKNAR PERCU-SCAN (K881850)Teknar, Inc.1988-08-29
SFRE 199-2 MEDIUM, CATALOG NO. 200-2192 (K883450)J R Scientific1988-08-29
MEDIUM 199, 10X, CATALOG NO. 210-3555 (K883495)J R Scientific1988-08-29
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM (K882593)Cardio Metrics, Inc.1988-08-29
NEWBORN CALF SERUM, CATALOG NO. 110-1130 (K883368)J R Scientific1988-08-29
ELIMINATOR AIR FILTER (K882468)Apex Medical, Inc.1988-08-29
MEDIPAC II EC (TM), MODEL 7900 (K882820)Medical Devices, Inc.1988-08-29
MEDIUM 199, CATALOG NO. 200-2031 (K883366)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511 (K883447)J R Scientific1988-08-29
BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES (K882392)Roseburg SA1988-08-26
SURGICAL SHIRT (K883464)Arkansas Lighthouse For the Blind1988-08-26
DERMICEL, MONTGOMERY STRAP (K882696)Bioseal1988-08-26
ORAL-B FLOSSERS (K883024)Oral-B Laboratories1988-08-26
PRO-FECT O.R. TOWEL (K882000)Network Trading Corp.1988-08-26
PRO-FECT LAPAROTOMY SPONGES (K882021)Network Trading Corp.1988-08-26
LQ1106 OPHTHALMIC YAG LASER (K882772)Keeler Instruments, Inc.1988-08-26
STERI-CLENS WOUND CARE KIT (K883250)Absorbent Cotton Co., Inc.1988-08-26
ULTRASONIC DENTURE CLEANER (K881391)Tatung Company of America, Inc.1988-08-26
ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA (K882471)Ear Tech, Inc.1988-08-26
CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS (K882491)Steri-Sol, Inc.1988-08-26
ASST-3000 SPINAL SURGERY TABLE (K883457)Orthopedic Systems, Inc.1988-08-26
DENTAL HAND INSTRUMENTS (K883322)Collagen Corp.1988-08-26
LANCET, BLOOD (K883420)Primrose Medical, Inc.1988-08-26
MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (K883303)Mentor Corp.1988-08-26
COLGATE DENTAL FLOSS (K883335)Colgate-Palmolive Co.1988-08-26
XACT NEISSERIA (K880511)Austin Biological Laboratories1988-08-25
SURGICAL CONNECTING TUBES (K883473)Westmark, Sterile Packing Systems, Inc. (Sps)1988-08-25
HORIZON 2000 PULSE OXIMETRY AND MODULE (K882273)Mennen Medical, Inc.1988-08-25
COAG-I PT TEST CARD (K882456)Cardiovascular Diagnostic Services1988-08-25
COAG-I ANALYZER, ALPHA MODEL (K882444)Cardiovascular Diagnostic Services1988-08-25
GPS/WGPS/PREVIEW GP (K874854)Labsonics, Inc.1988-08-25
STIHLER ASTOTHERM IFT 200, IFT 220 (K882361)Stihler Electronic, C/O Worldwide Regul. Services1988-08-25
HISTO-CHECK SLIDES (K883208)Val Tech Diagnostics, Inc.1988-08-25
30 IV EXTENSION SET W/TWO MALE LUER LOCKS (K882503)Churchill Medical Systems, Inc.1988-08-25
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER (K882370)Toa Medical Electronics USA, Inc.1988-08-25
OWREN'S VERONAL BUFFER (K883484)Helena Laboratories1988-08-25
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K882325)Sclavo, Inc.1988-08-25
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT (K873529)Diagnostic Hybrids, Inc.1988-08-25
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD (K882452)Medtronic Vascular1988-08-25
MULTIPLE SPECTACLE FRAMES (K883100)Metal Optics U.S.A., Inc.1988-08-25
VESSEL DILATOR AND INTRODUCER SHEATH (K882238)Ideal Medical, Inc.1988-08-25
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (K883333)Immuno-Mycologics, Inc.1988-08-25
METATECH MICROCLIP APPLICATOR (K882367)Metatech Corp.1988-08-25
HYSTEROSCOPE AUTONOM 4992 (K880314)Richard Wolf Medical Instruments Corp.1988-08-25
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1 (K883114)Pmt Corp.1988-08-24
GAMBRO MULTIPURPOSE SYSTEM MPS-10 (K881270)Gambro, Inc.1988-08-24
VIGGO INSUFLON (K881767)Ohmeda Medical1988-08-24
SUNGLASSES, NON-PRESCRIPTION (K882769)Spotlight Industries, Inc.1988-08-24
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (K883480)Site Microsurgical Systems, Inc.1988-08-24
ACUMED 9000 ETCO(2) MONITOR (K882661)Acumed Technologies, Inc.1988-08-24
OPTICAL OR EYEGLASS FRAME (K883226)Unique Optic , Ltd.1988-08-24
MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K881834)Ge Medical Systems Information Technologies1988-08-24
BREATHING CIRCUIT W/HEATED WIRE (K880769)Dryden Corp.1988-08-24
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR) (K882743)Ohmeda Medical1988-08-24
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Every clearance here is in the API, with alerts when new ones post.