Atlas FDA

1988

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

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RecordFirmDate
LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS (K882029)Pasco Laboratories, Inc.1988-07-06
BIOSIGN (K872867)Clinical Technology Corp.1988-07-06
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) (K881717)Buckman Co., Inc.1988-07-05
CONDOM (K881735)Iris Medical Ent., Inc.1988-07-05
SPTL-1 PULSED DYE LASER (K882243)Candela Laser Corp.1988-07-05
MODIFIED LABELING FOR TOXI-LAB THC SCREEN (K875182)Marion Laboratories, Inc.1988-07-05
HEARING AID (ALL-IN-THE-EAR) (K882150)Clear-Tone Hearing Aid Center1988-07-05
ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT. (K882104)Paramax Systems Div. Baxter Healthcare1988-07-05
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER (K882409)Phonic Ear, Inc.1988-07-05
PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA (K881691)Shiley, Inc.1988-07-05
SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER (K881734)Shiley, Inc.1988-07-05
CANON AUTOREFRACTOMETER R-20 (K882287)Canon USA, Inc.1988-07-01
DS-200 AND DS-400 T.E.N.S. (K881832)Delta Marketing, Inc.1988-07-01
DIGITAL NUCLEAR IMAGING SYSTEM (K875198)Medasys, Inc.1988-07-01
G-MARK (K880076)Bainbridge Laboratories, Inc.1988-07-01
NIDEK ARK-2000 (K882191)Nidek, Inc.1988-07-01
BIOPSY FIXATION UNIT-TYPE UA 0997 (K875357)Bruel & Kjaer Industri A/S1988-07-01
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT (K881231)Intertech Resources, Inc.1988-07-01
DISTOMETER (K882575)Hagg-Streit Service, Inc.1988-07-01
ALCON SITE(R)-COMPATIBLE CASSETTE (K881682)Alcon Laboratories1988-07-01
SPECIFIC CHEMISTRY ANALYZER (K882081)The Rupp & Bowman Co.1988-07-01
PAT PLATELET AGGREGATION TEST (K881829)Streck Laboratories, Inc.1988-07-01
SPECTROLYSE/FIBRIN (K881037)Cytrx Biopool, Ltd.1988-07-01
BODAI M.D.D. ADAPTOR(TM) (K881849)B&B Medical Technologies, Inc.1988-07-01
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K (K881795)Shimadzu Precision Instruments, Inc.1988-07-01
ESPE VARNISH (K880741)Espe GmbH (Us)1988-07-01
UNI-PORT (K880543)Surgeon Surgical Instrumentation, Inc.1988-07-01
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT (K882343)Terumo Medical Corp.1988-07-01
APOLLO CONDOM (K874236)Apollo Enterprise, Ltd. Co.1988-07-01
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL (K881113)Creative Laboratory Products, Inc.1988-07-01
DSL SOMATOMEDIN-C (DSL #5600) (K875229)Diagnostic Systems Laboratories, Inc.1988-07-01
SITE ULTRASONIC I/A PHACO NEEDLE (K882103)Site Microsurgical Systems, Inc.1988-07-01
MINIFUGE, MODEL 70 (K882149)Utah Bioresearch, Inc.1988-07-01
PROSTHODENT VL (K881903)Lee Pharmaceuticals1988-07-01
SIMPLASTIN EXCEL S (K882214)Organon Teknika Corp.1988-07-01
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY (K882294)Syva Co.1988-07-01
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT (K880750)Nova Biomedical Corp.1988-07-01
SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (K881165)Sakura Finetek U.S.A., Inc.1988-07-01
NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM (K881635)Noetix, Inc.1988-07-01
HEMOGLOBIN SCREENING DEVICE (K882101)Portable Medical Laboratories, Inc.1988-07-01
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (K882495)Lakewood Biochemical Co., Inc.1988-07-01
BIOTROL TOTAL PROTEIN H.P. (K882189)Biotrol, USA, Inc.1988-07-01
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 (K874910)Shimadzu Precision Instruments, Inc.1988-07-01
INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE (K882421)Dermacare Products, Inc.1988-06-30
ZINDRICK IM ROD INSTRUMENTS (K882443)Buckman Co., Inc.1988-06-30
VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM (K881349)Cryosurg, Inc.1988-06-30
MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 (K882323)Meicor, Inc.1988-06-30
MASK, GAS, ANESTHETIC (K882434)Eastmed Enterprises, Inc.1988-06-30
INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (K882346)Nordbye, Milchman, Barlage1988-06-30
#557 DISPOSABLE CARDIOVASCULAR CLAMP (K881448)Alpha Industries, Inc.1988-06-30
FIXATOR PIN (EXTERNAL) (K881511)Orthopedic Systems, Inc.1988-06-30
HYPODERMIC NEEDLE SHEATH HOLDER (K882405)Ansr Ent., Inc.1988-06-29
ASTROSCAN 2100 MICROTITER PLATE READER (K881458)Astroscan , Ltd.1988-06-29
CORIN MODULAR MOORE STEM (K881288)Orthopedic Systems, Inc.1988-06-29
CORIN BIPOLAR PROSTHESIS (K881289)Orthopedic Systems, Inc.1988-06-29
PROFORMA/PS TOTAL HIP SYSTEM (K880435)Orthomet, Inc.1988-06-29
CANNULA MODEL AR-6001 (K880295)Arthrex Arthroscopy Instruments, Inc.1988-06-29
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM (K882241)Kirschner Medical Corp.1988-06-29
(CHOICE) ALSO (KONDUM) (K880919)Select Sources, Inc.1988-06-29
NEPHROSS I.Q. ALLEGO (K882213)Organon Teknika Corp.1988-06-28
MSI 3003 SERIES BED (K881964)Med Service, Inc.1988-06-28
HOOD TRACHEAL STOMA BUTTON (K882430)Hood Laboratories1988-06-28
OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL (K881091)Coe Laboratories, Inc.1988-06-28
ULTRAVIOLET LIGHT PROTECTVE EYEWERE (K880666)Free Sun Intl. AB1988-06-28
SLC HARD LENS CLEANER (K880688)Ocular Pharmaceuticals, Inc.1988-06-28
HR-1000 W/SUFFIXES (B,C OR D) (K882184)Eigen1988-06-28
MSI 3002 SERIES BED (K881963)Med Service, Inc.1988-06-28
HI FLOW 50 (K882328)Minnesota Valley Engineering, Inc.1988-06-28
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (K882351)Lakewood Biochemical Co., Inc.1988-06-28
NEPHROSS I.Q. MODERATO (K882215)Organon Teknika Corp.1988-06-28
BIO*NEPHROSS I.Q. ANDANTE (K882339)Organon Teknika Corp.1988-06-28
RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE (K881980)Habley Medical Technology Corp.1988-06-28
RIGEL MODEL MULTICARE 409 (K875160)Rigel Medical Electronics, Inc.1988-06-28
JAYCO HYDROGEN MONITOR (K882499)Enteron, Inc.1988-06-28
DIDECO-SHILEY AUTOTRANS BT 795/AA (K881683)Shiley, Inc.1988-06-27
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS (K881367)Instrumentation Laboratory CO1988-06-27
KTP/532(TM) SURGICAL LASER (K881788)Laserscope1988-06-27
3M WOUND CONTACT MATERIAL, PRODUCT #563X (K881988)3M Company1988-06-27
SURGICAL GARMENTS (K880484)Greene International Corp.1988-06-27
NEW JELLIACOAT (K880189)K&G Import/Export Co.1988-06-27
STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT (K882253)Stoute'S "Assist-Seat" Corp.1988-06-27
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (K881358)Neuroscientific Corp.1988-06-27
ICU SARACAP (K881093)Ppg/Applied Resources, Inc.1988-06-24
DELFIA ESTRADIOL KIT (K882173)Pharmacia, Inc.1988-06-24
NASAL CPAP SYSTEM (K881833)Healthdyne, Inc.1988-06-24
MODIFIED DIGITAL CLINICAL THERMOMETER (K880759)Epson America, Inc.1988-06-24
MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN (K875219)Keystone Diagnostics, Inc.1988-06-24
TOTAL PROTEIN/ALBUMIN STANDARD (K882116)Verichem Laboratories, Inc.1988-06-24
HUMID-VENT FILTER (K881657)Gibeck Respiration1988-06-24
GDS ENZYMATIC SALICYLATE REAGENT (K882038)Gds Technology, LLC1988-06-24
ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY (K875042)Surgilase, Inc.1988-06-24
MICROMEDIC MORPHINE RIA KIT (K881102)Icn Micromedic Systems1988-06-24
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON. (K880963)Buckman Co., Inc.1988-06-24
MODEL 172-P AND 172-N ROTARY SPRAY ARM (K882465)Boling Precision Components Co.1988-06-24
SARACAP AG (K882172)Ppg/Applied Resources, Inc.1988-06-24
FERTILITY FORECASTER COMPUTER PROGRAM (K880618)Fertile Time, Ltd.1988-06-24
DESERET SUBCLAVIAN HEMODIALYSIS CATHETER (K881695)Deseret Medical, Inc.1988-06-23
VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER (K881743)Vas-Cath, Inc.1988-06-23
SUIT, SURGICAL (K882282)A Plus International, Inc.1988-06-23
KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN (K880382)Kimberly-Clark Corp.1988-06-23
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