Atlas FDA

1988

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL (K882535)Abbott Laboratories1988-07-14
LATEX EXAM GLOVES, NON-STERILE (K882583)B Und J Instruments1988-07-14
RESUS-AID (K881065)Applied Convergent Technologies, Inc.1988-07-14
EXTENDED LIFE CAPD TRANSFER SET 5C4444 (K882498)Baxter Healthcare Corp1988-07-13
VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT (K882100)Vitaphore Corp.1988-07-13
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (K881636)Coloplast A/S1988-07-13
ENTERAL FEEDING TUBES (K881978)Primrose Medical, Inc.1988-07-13
MR. RAZOR II TWIN (K882388)Burney Products Corp.1988-07-13
POWER EXAMINATION TABLE (K882010)Enochs Mfg., Inc.1988-07-13
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373 (K882455)Baxter Healthcare Corp1988-07-13
VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER (K882466)Vas-Cath, Inc.1988-07-13
MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM (K881705)Surgi-Med, Inc.1988-07-13
DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (K880322)Dentronix, Inc.1988-07-13
JEDMED/POLACK KERATOSCOPE HS/SL (K882618)Gamut Ent.1988-07-13
CLINICAL ELECTONIC THERMOMETERS (K881368)Sheridan Catheter Corp.1988-07-13
CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM (K882092)Gaymar Industries, Inc.1988-07-13
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 (K874938)Sp Innovations, Inc.1988-07-12
ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (K874255)Minnesota Laser Corp.1988-07-12
IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 (K882302)Y1988-07-12
PROXIMA 1 PH MONITOR (K881706)Technomanagement, Inc. C/O C.G.1988-07-12
ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (K874253)Minnesota Laser Corp.1988-07-12
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88) (K882301)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-12
HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK (K882045)Cordis Leads, Inc.1988-07-12
SYSMEX QUICKLYSER-II (QLS-200A) (K882267)Toa Medical Electronics USA, Inc.1988-07-12
ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM (K882161)Ssi Medical Services, Inc.1988-07-12
MSI 4000 SERIES BED (K881782)Med Service, Inc.1988-07-12
ACCRAASSAY RID KITS (K882369)Icn Immunobiologicals1988-07-12
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (K882304)Abco Dealers, Inc.1988-07-12
ESCORT - PORTABLE PATIENT MONITOR (K881986)Medical Data Electronics1988-07-12
TRACER(TM) II BLOOD GLUCOSE SYSTEM (K881908)Boehringer Mannheim Corp.1988-07-12
TECNOL CATHETER LEG STRAP (K882641)Tecnol New Jersey Wound Care, Inc.1988-07-12
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL (K882534)Abbott Laboratories1988-07-12
HARMONY HEARING AID MODELS LP, M, HO, HF, & C (K882005)Harmony Hearing Aids, Co.1988-07-12
STAT-20 FLUOROMETER (K882677)Weaver Medical1988-07-12
SPECIAL PROCEDURES BASE UNIT MODEL 500 (K881713)Gempco, Inc.1988-07-12
EMIT HVA COCAINE METABOLITE ASSAY (K881942)Syva Co.1988-07-12
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88) (K882300)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-12
HORIZON 2000 ARRHYTHMIA MONITORING OPTION (K881273)Mennen Medical, Inc.1988-07-12
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (K882513)Cardiac Resucitator Corp.1988-07-12
EMIT HVA PHENCYCLIDINE ASSAY (K882179)Syva Co.1988-07-12
CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM (K882105)Dianon Systems, Inc.1988-07-11
LIQUI-SERA SERUM ALCOHOL CONTROLS (K881430)Biodiagnostic Intl1988-07-08
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM (K882622)Technicon Instruments Corp.1988-07-08
LO-CORE NEEDLE (K882064)Device Labs, Inc.1988-07-08
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (K882580)Precision Dynamics Corp.1988-07-08
SITZMARKS (K881609)Lafayette Pharmacal, Inc.1988-07-08
RESUSCITATOR VALVE ASSEMBLY W/FILTER (K882204)Intertech/Ohio1988-07-08
BLOOD PH CAPILLARY TUBES, HEPARIN (K881188)Helps Products, Inc.1988-07-08
QM300 IGG ANTIBODY PACK (K882083)Kallestad Diag, A Div. of Erbamont, Inc.1988-07-08
ELAN-E DISPOSALBE DRAPE (K882494)Dermacare Products, Inc.1988-07-08
DU PONT VCA-IGM ANTIBODY ELISA KIT (K875204)E.I. Dupont DE Nemours & Co., Inc.1988-07-08
EMIT HVA CONTROL KIT (K881944)Syva Co.1988-07-08
SL-100 ND:YAG LASER FOR GYNECOLOGY USE (K871512)Medical Energy, Inc.1988-07-08
PROTECTO-SHIELD (K881913)Syntech Mfg. Services1988-07-08
ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE (K881654)Medical Safety Products, Inc.1988-07-08
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY (K881679)Ciba Corning Diagnostics Corp.1988-07-08
IMMUNOCARD(TM) HCG II TEST KIT (K881709)Disease Detection International, Inc.1988-07-08
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL (K881503)Baxter Healthcare Corp1988-07-08
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM (K882621)Technicon Instruments Corp.1988-07-08
HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD (K881907)Enzo Biochem, Inc.1988-07-08
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (K881894)Cambridge Bioscience Corp.1988-07-08
QUANTAI BG(TM) REAGENT STRIP (K880703)Quantai Biotronics, Inc.1988-07-08
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN (K881846)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-08
4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER (K881619)Heraeus Lasersonics, Inc.1988-07-08
APPOLLO BATH (K882669)Electric Mobility, LLC1988-07-08
IMMUNOCCULT EIA TEST KIT (K871143)Intl. Immunoassay Laboratories, Inc.1988-07-08
X-RAY GENERATING SYSTEM, TF 800 (K881387)Absolute X-Ray Corp.1988-07-08
MONOCLONAL RADIAL IMMUNODIFFUSION KIT (K881928)The Binding Site, Ltd.1988-07-08
DIDECO-SHILEY FLUID COLLECTION BAG (K881692)Shiley, Inc.1988-07-08
COOL EYE(TM) EYE PROTECTOR (K881135)Cool Eyes, Inc.1988-07-08
MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES (K880702)Fisher & Paykel Allied Products , Ltd.1988-07-08
RADKOR, CST-18 (K882563)Radkor, Inc.1988-07-08
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM (K882446)Technicon Instruments Corp.1988-07-08
UNIVERSALLY ADJUSTABLE ARMBOARD (K882524)Karlin Technology, Inc.1988-07-08
EMIT HVA CALIBRATOR KIT (K881943)Syva Co.1988-07-08
CONDOM (K881100)Glnic Corp.1988-07-08
X-RAY GENERATING SYSTEM TF 1000 (K881386)General Medical Merate S.P.A1988-07-08
BIOTROL ALKALINE PHOSPHATASE (K881742)Biotrol, USA, Inc.1988-07-08
UNSATURATED IRON BINDING CAPACITY (K881761)Data Medical Associates, Inc.1988-07-08
ADULT STAR (K872466)Infrasonics Corp.1988-07-08
WAKO(TM) CRP (K882374)Wako Chemicals USA, Inc.1988-07-08
PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (K882623)Technicon Instruments Corp.1988-07-08
QM300 ALBUMIN ANTIBODY PACK (K882082)Kallestad Diag, A Div. of Erbamont, Inc.1988-07-08
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM (K882620)Technicon Instruments Corp.1988-07-08
ALPINE PORTABLE OXYGEN GENERATOR (K881802)Mountain Medical Equipment, Inc.1988-07-08
KEVOR-CURETTE (K882404)Euro-Med Intl.1988-07-08
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) (K881639)Eastman Kodak Company1988-07-08
LINDLEY II RESUSCITATOR (K881689)Lindley Resuscitator, Inc.1988-07-08
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (K881852)Helena Laboratories1988-07-08
IVORY FINDER SET (K881794)Ivory Instruments Co.1988-07-08
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS (K882489)Ohmeda Medical1988-07-08
ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72 (K881923)Ultraviolet Resources Intl.1988-07-07
CANNULA MODEL AR-6551 (K881792)Arthrex Arthroscopy Instruments, Inc.1988-07-07
ANTI-CYTOKERATIN MONOCLONAL ANTIBODY (K864893)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-07
PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI (K882381)Pioneering Technologies, Inc.1988-07-07
TDX (R) DIGOXIN NXT (K882233)Abbott Laboratories1988-07-06
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS (K881437)Hichem Diagnostics1988-07-06
ACCU-CULSHURE TM (K882637)Accu-Med Corp.1988-07-06
SHILEY FEMORAL CORONARY PERFUSION CATHETER (K881733)Shiley, Inc.1988-07-06
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN (K881438)Hichem Diagnostics1988-07-06
← Previous Next →

Track 1988 automatically

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