Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SAFETY SHIELD SUCTION CATHETER (K873810)Ballard Medical Products1987-12-11
CUSTOM PROCEDURE TRAYS (K871616)Medical Custom Products, Inc.1987-12-11
HEARING AID (ALL-IN-THE-EAR) (K874218)Audiology & Hearing Aid Clinic1987-12-11
HERPES 1 AND 2 MICROASSAYS (K871420)Diamedix Corp.1987-12-11
STERI-CLENS(TM) SURGICAL SCRUB SPONGE (K874741)Absorbent Cotton Co., Inc.1987-12-10
CONVERTA-LITTER (K874060)Camtec1987-12-10
SONICATOR 720 (MODEL ME720) (K873812)Mettler Electronics Corp.1987-12-10
HEARING AID (ALL-IN-THE-EAR) MODEL WORD SORTER (K874764)Clear Corp.1987-12-10
ARTHROTRACT UPPER LIMB TRACTION ACCESSORY (K874762)Andronic Devices, Ltd.1987-12-10
CK 4900 SERIES, GOWN AND TOWEL PAK (K874760)Currie Medical Specialties, Inc.1987-12-10
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL (K874375)Abbott Laboratories1987-12-10
THOMPSON HIP PROSTHESIS (K874617)Orthopedic Systems, Inc.1987-12-10
POWER EXERCISE EQUIPMENT (K874196)Arc Motion , Ltd.1987-12-10
PLASTER VACUUM, 230V MODEL NO. 4183-161 (K873723)Martin Medical1987-12-10
INTERPRO INT'L, INC. ISOLATION GOWN (K874766)Interpro Intl., Inc.1987-12-10
HOT ROD THERMAL MASSAGE ROLLER (K873794)American Progressive Products Corp.1987-12-10
OTICON MODEL I50 IN-THE-EAR HEARING AID (K874744)Oticon Corp.1987-12-10
MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. (K873887)W.R. Grace & Co.-Conn.1987-12-09
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC (K874466)Analytical Products, Inc.1987-12-09
MERITEC(TM)-GC (K874078)Meridian Diagnostics, Inc.1987-12-09
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) (K874650)Quinton, Inc.1987-12-09
HEARING AID (ALL-IN-THE-EAR) (K873003)Acoustical Hearing Services, Inc.1987-12-08
KIMONO (CONDOMS) (K872799)Mayer Laboratories1987-12-08
RIGID-LENS CASE (K874657)Sola Ophthalmics1987-12-08
NICOLET DIGITAL TWO PIECE HEARING AID (K873736)Nicolet Biomedical Instruments1987-12-08
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR (K872645)Richards Medical Co., Inc.1987-12-08
SERVICE MASTER (IMPULSE) (K873300)Richards Medical Co., Inc.1987-12-08
JDM SP2 SENSOR (K873806)Jd Monitoring C/O Mackler, Cooper and Gibbs1987-12-08
BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE (K873763)Geistlich-Pharma1987-12-08
BESTCON/SPERMICIDE (K871451)Europharmaceutical Corp.1987-12-08
STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX) (K874718)Schmid Laboratories, Inc.1987-12-08
MOTHER'S MILK BAG (K874071)Yanase Waitch K.K.1987-12-08
BIO-MEDICUS CANNULA-TUBING (K872033)Bio Medicus, Inc.1987-12-07
FOLEY CATHETER TEMPERATURE SENSOR (K873448)Respiratory Support Products, Inc.1987-12-07
AEROSOL DELIVERY SYSTEM (AERO-TECH II) (K873930)Cadema Medical Products, Inc.1987-12-07
UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (K872715)Roseburg SA1987-12-07
MEDTRONIC PERMANENT LEAD INTRODUCER (K874167)Medtronic Vascular1987-12-07
WILSON-COOK BIOPSY FORCEPS (K874314)Wilson-Cook Medical, Inc.1987-12-07
MODIFIED DSP100 AMPLIFIER (K873640)Intl. Acoustics, Inc.1987-12-07
H.T.U. (HYPERBARIC THERAPY UNIT) (K874107)Hyox Systems C/O Mechidyne Systems, Inc.1987-12-07
BIOMA 3500 (K872370)E.B.S., Inc.1987-12-07
CORMED III AMBULATORY INFUSION PUMP (K873847)C.R. Bard, Inc.1987-12-07
ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM (K873343)Entech, Inc.1987-12-07
JEHLE CORONARY PERFUSION CATHETERS (K874242)Pilling Co.1987-12-07
RESUBMITTED STANDARD MICROPORE ECG ELECTRODE (K874628)Labeltape Meditect, Inc.1987-12-07
NEW C-D SYSTEM FOR SPINAL SURGERY (K873977)Sofamor Co.1987-12-07
PLASTER VACUUM, 115V MODEL NO. 4183-160 (K873721)Martin Medical1987-12-07
GUIDE WIRE (K874164)Endovations1987-12-07
HI-NEK TOTAL HIP (K873632)Orthopedic Systems, Inc.1987-12-07
TITANIUM BONE SCREWS (K874130)Orthopedic Systems, Inc.1987-12-07
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION (K871490)Ge Medical Systems Information Technologies1987-12-07
MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY (K874238)Belmont Equipment Corp.1987-12-07
TRICHOMONAS DIRECT ENZYME IMMUNOASSAY (K874259)California Integrated Diagnostics, Inc.1987-12-07
ENVIRACAIRE MODEL EV-1 (K872359)Enviracaire Corp.1987-12-07
URETHAL CATHETER (K874309)Medovations, Inc.1987-12-07
ENTERAL FEEDING TUBE (K874393)Wilson-Cook Medical, Inc.1987-12-07
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC (K874175)Otisville Biopharm, Inc.1987-12-04
HEMO-SOL (K874461)Chem Pharm, Inc.1987-12-04
BIOTIS (TM) BCYE (K874177)Otisville Biopharm, Inc.1987-12-04
COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (K872576)Enzo Biochem, Inc.1987-12-04
MODIFIED USE OF TRIANGLE BANDAGE STERILE (K874161)K. W. Griffen Co.1987-12-04
STRUNG DENTAL ROLLS (K872810)American Silk Sutures, Inc.1987-12-04
BIOTIS (TM) BCYE SELECTIVE (K874178)Otisville Biopharm, Inc.1987-12-04
DGH-3000A A-SCAN (K872726)Dgh Technology, Inc.1987-12-04
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K874131)Pointe Scientific, Inc.,1987-12-04
BERNAFON COLIBRI, C-2H HEARING AIDS (K874589)Bernafon, Inc.1987-12-04
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 (K874639)Shimadzu Precision Instruments, Inc.1987-12-04
ENTERON ABDOMINAL PARACENTESIS TRAY (K874063)Endovations1987-12-04
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP (K874174)Otisville Biopharm, Inc.1987-12-04
LEWIS SAFE SLEEVE (K873960)Cheri Lewis, D.D.S.1987-12-04
MICRO-GUIDE (K870700)Catheter Research C/O Burditt, Bowles & Radzius1987-12-03
MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR (K873672)Novametrix Medical Systems, Inc.1987-12-03
CHEMO-PORT NON-CORING NEEDLES (K873165)Hdc Corp.1987-12-03
STUBBIE STEERABLE GUIDEWIRE (K873543)Target Therapeutics1987-12-03
NUMED PTA CATHETERS (K871796)NuMED, Inc.1987-12-03
'CATCH-IT' OR FECAL CONTAINMENT DEVICE (K873929)Midwest Medical Co.1987-12-03
STACHROM VIII:C TEST KIT (K874097)American Bioproducts Co.1987-12-03
TEMPORARY PACEMAKER ELECTRODE (K872972)Oscor Medical Corp.1987-12-03
PHARMASEAL RUBBER URETHRAL CATHETER (K874517)American Pharmaseal Div. Ahsc1987-12-03
PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (K874045)American Pharmaseal Div. Ahsc1987-12-03
STERILIZED DENTAL BIT PACKAGING (K873698)Florida Diamond Instruments Corp.1987-12-03
CUMEVAC (K874410)Cumes-Honikman Partnership1987-12-03
OHMEDA BIOX 3760 PULSE OXIMETER (K874104)Ohmeda Medical1987-12-03
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+ (K873776)Y1987-12-03
MSS ENTERAL DELIVERY SET (K872921)Medical Support, Inc.1987-12-03
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE (K873921)Intermedics, Inc.1987-12-03
EDSLAB (R) OCCLUSION BALLOON CATHETER (K873485)American Edwards Laboratories1987-12-03
CLOSED WOUND DRAINAGE SYSTEMS (K874645)Hall Laboratories, Inc.1987-12-02
COMPANION MINI OXYGEN SAVER (K873901)Puritan Bennett Corp.1987-12-02
PERFORATED SOAKING TUBE (K874596)Specialty Medical Products Co.1987-12-02
SPIRO ANALYZER ST-300 (K873817)Futuremed Div. of Future Impex Corp.1987-12-02
AUTO SUTURE PURSE STRING APPLIER* (K874428)United States Surgical, A Division of Tyco Healthc1987-12-02
NSN #6515-00-333-2400 ADSON DRESSING FORCEPS (K874634)I-Tech Industries, Inc.1987-12-02
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO (K874426)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-12-02
PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (K873911)Richmond Products, Inc.1987-12-02
CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (K874276)Cox-Uphuff Intl.1987-12-02
BEAR VH-820 HUMIDIFIER (K873634)Bear Medical Systems, Inc.1987-12-02
COLOR BOOK ILLUMINATOR STAND (K873913)Richmond Products, Inc.1987-12-02
MAXIMUM CONTROL GOWN (K874318)Ulti-Med Intl., Inc.1987-12-02
MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER (K874503)Micro-Aire Surgical Instruments, Inc.1987-12-02
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Every clearance here is in the API, with alerts when new ones post.