Atlas FDA

1988

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

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RecordFirmDate
PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER (K874877)Pegasus Airwave, Inc.1988-02-22
VICOR PACER, MODEL 410A (K880432)Tpl-Cordis, Inc.1988-02-22
MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) (K874480)Omikron Scientific, Ltd.1988-02-22
S9 DISPLAY SYSTEM (K874214)O.M.I. Oncology Microsystems, Inc.1988-02-22
MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH (K880583)Quinton, Inc.1988-02-22
HERACURE LS 500 (K875078)W.C. Heraeus GmbH1988-02-22
PB-A LEAD-ACID BATTERY CONVERSION KIT (K875106)Diagnostic Imaging Specialists Corp.1988-02-22
LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM (K872369)Loma Linda University Medical Center1988-02-22
A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH (K872525)M.C. Johnson Co., Inc.1988-02-22
VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (K875074)Timeter Instrument Corp.1988-02-22
DERMGARD SYSTEM 800 AND 900 (K880486)Dermgard, Inc.1988-02-22
AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID (K874831)Dahlberg Electronics, Inc.1988-02-22
MODEL 492 SSR (TM) RECORDER (K874313)Del Mar Avionics1988-02-22
RHYTHMSCAN (K871572)Brentwood Instruments, Inc.1988-02-22
SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. (K875063)Epson EL Paso, Inc.1988-02-22
DERMATOLOGICAL PATCH (K872926)Convatec, A Division of E.R. Squibb & Sons1988-02-22
FRESENIUS HEMOFLOW F3, F4, F5, F7 (K874872)Seratronics, Inc.1988-02-19
HOLLYWOODS COOL SHADES (K874722)Tonka Corp.1988-02-19
RAPID COLORIMETRIC DIRECT STREP A TEST (K874761)New Horizons Diagnostics Co.1988-02-19
LOW-POWER BINOCULAR LOUPE (K875124)Seiler Instrument & Mfg. Co., Inc.1988-02-19
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM (K875214)Therex Corp.1988-02-19
PEYMAN G. 12.12 YAG LASER LENS (K875087)Ocular Instruments, Inc.1988-02-19
AMICON EQUALINE FLUID BALANCE SYSTEM (K875121)Amicon, Inc.1988-02-19
CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER (K880302)Hemotec, Inc.1988-02-19
GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS (K880084)Gambro, Inc.1988-02-19
SEA - PORT INFUSION SET (K880297)Harbor Medical Devices, Inc.1988-02-19
HOSKINS-BARKAN GONIOTOMY LENS 9MM (K875114)Ocular Instruments, Inc.1988-02-19
STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT (K873926)Storz Instrument Co.1988-02-19
KIMBERLY-CLARK PROFESSIONAL JACKET (K880385)Kimberly-Clark Corp.1988-02-19
IMMPULSE DIGOXIN ASSAY REAGENTS (K874748)Sclavo, Inc.1988-02-19
TRACK AND CARRIER, INTRAVENOUS (K880538)Ferguson Medical1988-02-19
LASERTRIPTER MINISCOPE (K874858)Candela Laser Corp.1988-02-19
MARLEN ULTRA ILEOSTOMY POUCH-5000 (K880327)Marlen Mfg. & Development Co.1988-02-19
ACUSON TRANSPERINEAL NEEDLE GUIDE (K874922)Acuson Computed Sonography1988-02-19
HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR (K872441)Advanced Technology Laboratories, Inc.1988-02-19
CEMENT LINER (K874945)Dentsply Intl.1988-02-19
FACTOR VIII REFERENCE PLASMA (K880292)Helena Laboratories1988-02-19
UFR DIGITAL RETROFIT (K875312)Yankee Intl. Medical Research & Mfg., Ltd.1988-02-19
STERILE SCRUBBY SCRUB BRUSH (K875033)Medsurg Industries, Inc.1988-02-19
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. (K874838)Coulter Electronics, Inc.1988-02-19
ASD-BIO ANTI-STICK DEVICE (K874602)Biosurge, Inc.1988-02-19
SONOLINE CF (K875272)Siemens Medical Laboratories, Inc.1988-02-18
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP (K874874)Advanced Cardiovascular Systems, Inc.1988-02-18
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT (K872632)E.I. Dupont DE Nemours & Co., Inc.1988-02-18
SARNS VENOATRIAL CATHETER (K875048)3M Health Care, Sarns1988-02-18
BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 (K880166)Clinical Technology Corp.1988-02-18
MICROTRAK HSV CULTURE IDENTIFICATION TEST (K880436)Syva Co.1988-02-18
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 (K874362)Amersham Corp.1988-02-18
TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD (K880215)Warsaw Orthopedic, Inc.1988-02-18
COXA ACETABULAR CUP (K871852)Thackray USA1988-02-18
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN (K873032)Biosound, Inc.1988-02-18
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 (K874808)Diagnostic Products Corp.1988-02-18
SERIES 77000 ULTRASOUND IMAGING SYSTEM (K873762)Hewlett-Packard Co.1988-02-18
STERI-CLENS (K875129)Absorbent Cotton Co., Inc.1988-02-18
PRECEPT(TM) CIPROFLOXACIN (K874727)Austin Biological Laboratories1988-02-18
MULTI-ENZYME LINEARITY SOLUTION (K880266)Verichem Laboratories, Inc.1988-02-18
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER (K874763)Instrumentation Laboratory CO1988-02-18
GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. (K874500)Harry J. Bosworth Co.1988-02-18
PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM (K871912)Electro-Diagnostic Instruments1988-02-18
PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (K880441)Plane Iii, Inc.1988-02-18
DSL ACTIVE ESTRADIOL RIA (DSL #4300) (K873550)Diagnostic Systems Laboratories, Inc.1988-02-18
ASPARTATE AMINOTRANSFERASE AST/SGOT (K875071)Tech-Co, Inc.1988-02-18
ACROMED CROSS ROD CONNECTOR (K874882)Acromed Corp.1988-02-18
WEHBE ARM HOLDER (K880265)Orthopedic Systems, Inc.1988-02-18
ARTHROBOT(TM) LOWER LIMB POSITIONER (K880227)Andronic Devices, Ltd.1988-02-18
MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK (K875325)Schneider-Shilley (Usa)1988-02-18
HIP, FEMUR AND HUMERUS RETRACTOR (K880151)Twenty-First Century Orthopedics, Inc.1988-02-18
SUN MEDICAL SMOKE EVACUATOR SYSTEM (K874948)Sun Medical, Inc.1988-02-18
TSRH H/M TORQUE LIMITING WRENCH (K880214)Warsaw Orthopedic, Inc.1988-02-18
CANYON MEDICAL FEMORAL BYPASS CANNULAE (K874899)Canyon Medical Products1988-02-18
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER (K880282)Lima-Lto, Inc.1988-02-18
CREATINE KINASE (COLORIMETRIC METHOD) (K880178)Tech-Co, Inc.1988-02-18
MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER (K875326)Schneider-Shilley (Usa)1988-02-18
SILASTIC NASAL IMPLANT S-TYPE (K880405)Dow Corning Wright1988-02-18
LYPHOCHEK WHOLE BLOOD CONTROL (K874731)Bio-Rad1988-02-18
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (K875199)Biotronik Sales, Inc.1988-02-18
TOWNLEY COX COMB ACETABULAR CUP (K880004)Orthomet, Inc.1988-02-18
HDL CHOLESTEROL PRECIPITATING REAGENT (K880176)Tech-Co, Inc.1988-02-18
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER (K874442)Critikon Company, LLC1988-02-18
THIELER KIT (K875153)Taris Corp.1988-02-18
HOOK PUNCH FORCEPS FOR ARTHROSCOPY (K880331)Kibbutz Gilgal Medical C/O Toam U.S.A. Corp.1988-02-18
PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG (K875201)Orthomet, Inc.1988-02-17
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR (K874776)Advanced Cardiovascular Systems, Inc.1988-02-17
GULLSORB IGG INACTIVATION REAGENT (K875254)Gull Laboratories, Inc.1988-02-17
QM300 CALIBRATOR B PACK (K875282)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-17
ACROMED AWL/PUNCH, DEPTH GAUGE (K880045)Buckman Co., Inc.1988-02-17
PERMCATH INSERTION TRAY (K874633)Quinton, Inc.1988-02-17
ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG (K873331)Directed Energy, Inc.1988-02-17
THE BELTONE 2000 AUDIOMETER (K875360)Beltone Electronics Corp.1988-02-17
MICRO-AIRE CEMENT REMOVAL TOOLS (K880324)Micro-Aire Surgical Instruments, Inc.1988-02-17
V-TREND IM DRY-SPOT TEST (K880399)Texas Immunology, Inc.1988-02-17
UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (K875354)Ulster Scientific, Inc.1988-02-17
MAT (TM) MICROALBUMIN TEST (K875161)Wampole Laboratories1988-02-17
MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR (K874893)Keithley Instruments, Inc.1988-02-17
FLIPSCREEN QAT (K874802)Alerchek, Inc.1988-02-17
I.V. START KITS (K875315)Ni-Med, Inc.1988-02-17
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID (K874830)Dahlberg Electronics, Inc.1988-02-17
RRT TOTAL IGE TEST KIT (K874541)Incstar Corp.1988-02-17
N-IMMUNOGLOBULIN LIGHT CHAIN KIT (K880341)Behring Diagnostics, Inc.1988-02-17
ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA. (K874860)Acuson Computed Sonography1988-02-17
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Every clearance here is in the API, with alerts when new ones post.