Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ROTATING HEMOSTATIC VALVE (K890800)Datascope Corp.1989-06-12
DENTAL X-RAY BITE BLOCK (K890355)Bite-A-Block1989-06-12
RESUBMITTAL OF MI 1000C MICROIMAGER (K881979)Ausonics Pty , Ltd.1989-06-12
GEM II ORTHODONTIC BRACKET (K892704)Ormco Corp.1989-06-12
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES (K891583)Y1989-06-09
TRU TRAC TRACTION TABLE (K893448)Tru-Trac1989-06-09
INNOFLUOR(TM) QUINDINE CALIBATOR SET (K892212)Innotron of Oregon, Inc.1989-06-09
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER (K891082)Depuy, Inc.1989-06-09
BICARBONATE; SYSTEM PACK REAGENTS (K891991)Boehringer Mannheim Corp.1989-06-09
COMMUNI-CALL (K893473)Carepartners, Inc.1989-06-09
ASSAYED CHOLINESTERASE CONTROL (K885282)Actio, Inc.1989-06-09
PATIENT EXAMINATION GLOVES (LATEX) (K891880)Jextrag Schaffhausen AG1989-06-09
CLIRANS HOLLOW FIBER HEMODIALYZER (WET) (K891477)Terumo Medical Corp.1989-06-09
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 (K893223)Helena Laboratories1989-06-09
TDP INFRARED HEAT LAMP (K890556)Toxicology Professionals, Inc.1989-06-09
LISTERIA SELECTIVE ENRICHMENT MEDIUM (K891593)Oxoid U.S.A., Inc.1989-06-09
INNOFLUOR(TM) QUINIDINE REAGENT SET (K892208)Innotron of Oregon, Inc.1989-06-09
ENAMEL MICROABRASION COMPOUND (K891536)Premier Dental Products Co.1989-06-09
ZAROLAN, DUALAN, TITAN AND SUPERON (K891698)Dent Zar, Inc.1989-06-09
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT (K883293)Storz Instrument Co.1989-06-09
QUIK-DOT TOXOPLASMOSIS (K890048)Ampcor, Inc.1989-06-09
DIALBUMIN (K891544)Exocell, Inc.1989-06-09
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 (K892424)Helena Laboratories1989-06-09
PATIENT EXAMINATION GLOVES (LATEX) (K892741)Dmacs Intl. Corp.1989-06-09
SENSITITRE AUTO ID PLATE AP80 (K890057)Radiometer America, Inc.1989-06-09
SR1 (FSH) IMMUNOENZYMETRIC ASSAY (K892706)Serono-Baker Diagnostics, Inc.1989-06-09
CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER (K891083)Depuy, Inc.1989-06-09
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (K891574)Em Diagnostic Systems, Inc.1989-06-09
PATIENT EXAMINATION GLOVES (LATEX) (K892288)Ansell, Inc.1989-06-09
TEGASORB(TM) ULCER DRESSING, #90-XXX (K891288)3M Company1989-06-09
PLYMOUTH & LAWANA EXAM GLOVES (K893149)Healthgard Medical Products Ltd. Partnership1989-06-09
PATIENT EXAMINATION GLOVES (K893056)Hope Rubber Industrial Corp.1989-06-09
MICRO-STRAIGHT POSTURE TRAINING DEVICE (K884976)Mcdowell Ent., Inc.1989-06-09
DELCLAMP (K893231)Delmed, Inc.1989-06-08
EXTENSION SET W/FLOW REGULATOR (K890489)Baxter Healthcare Corp1989-06-08
MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000 (K890730)Medsurg Industries, Inc.1989-06-08
DA-16 AND DA-24 SHUNT ADAPTERS (K893478)Akcess Medical Products, Inc.1989-06-08
SURGICAL LATEX STERILE GLOVES (K892056)Modern Rubber Industrial Co., Ltd.1989-06-08
CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER (K891997)Corometrics Medical Systems, Inc.1989-06-08
COMBOLASER MODEL 5050 (K893529)Lasermatic, Inc.1989-06-08
RUBELLA-CUBE(TM) (K892051)Difco Laboratories, Inc.1989-06-08
NU-TRAP SUCTION CATHETER W/MUCUS TRAP (K893462)Atheus Corp.1989-06-08
QUINTON SINGLE LUMEN CATHETER (K893188)Quinton, Inc.1989-06-08
STAR SYNC (K884521)Infrasonics Corp.1989-06-08
DATA EXCHANGE SYSTEM, MODEL 24 (K890921)Siemens Life Support Systems1989-06-08
CTI II STRAIGHT STEM (K891539)Orthopedic Systems, Inc.1989-06-08
S 22 INSTRUMENT STAND (K891584)Carl Zeiss, Inc.1989-06-08
EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 (K883865)Acutronic Medical Systems AG1989-06-08
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS (K891297)Playtex Family Products, Inc.1989-06-08
SITE PHACO PLUS INFUSION SLEEVE (K892852)Site Microsurgical Systems, Inc.1989-06-08
RESPITRAK (K884959)Non-Invasive Monitoring Systems, Inc.1989-06-08
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 (K891753)Akcess Medical Products, Inc.1989-06-08
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K (K891755)Akcess Medical Products, Inc.1989-06-08
T SERIES VESSEL TIPS (K893438)Akcess Medical Products, Inc.1989-06-08
MONAGHAN RVM, MODEL 761 (K884942)Monaghan Medical Corp.1989-06-07
CLA 200 CHEMPRO(R) LIPID ANALYZER (K892238)Johnson & Johnson Professionals, Inc.1989-06-07
ARGENCO W (K893237)Argen Precious Metals, Inc.1989-06-07
ABRAKADABRA - DENTAL ADHESIVE SYSTEM (K892003)Parkell1989-06-07
ATRAUMAX(TM) SURGICAL CLAMPS (K891296)Applied Vascular Devices, Inc.1989-06-07
MODIFIED ULTIMA LITE (K892144)Deringer-Ney, Inc.1989-06-07
EASY-TEST IRON (IRON) ITEM NO. 16686 (K892863)Em Diagnostic Systems, Inc.1989-06-07
HELENA THROMBOPLASTIN REAGENT (K892050)Helena Laboratories1989-06-07
MIX CONTAINER W/ATTACHED TRANSFER SET (K885173)Medical Support Systems1989-06-07
TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION (K891474)Tambrands, Inc.1989-06-07
EXETER II TOTAL HIP SYSTEM (K891454)Howmedica Corp.1989-06-07
MICROSEPT 60/20 (K890844)Arbor Technologies, Inc.1989-06-07
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY (K890842)Maico Hearing Instruments, Inc.1989-06-07
PATIENT EXAMINATION GLOVES (LATEX) (K892099)Tung Kuang Rubber Factory Co. , Ltd.1989-06-07
SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE (K891452)Diasonics, Inc.1989-06-07
DENTCLEAN CONCENTRATED DENTURE CLEANSER (K890043)K-P Co.1989-06-07
LATEX DISPOSABLE EXAMINATION GLOVES (K892919)Union Industrial Co., Ltd.1989-06-07
TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO (K891473)Tambrands, Inc.1989-06-07
TRANS-ORAL DEPTH GAUGE (K893415)Ruggles Corp.1989-06-07
ACCUSPEC THYROID UPTAKE SYSTEM (K891466)Nuclear Data, Inc.1989-06-06
TELSTAR MODEL PP ITE HEARING AID (K892460)Telstar Electronics, Inc.1989-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K892701)Nature'S Farm Products (Thailand) Co., Ltd.1989-06-06
PATIENT EXAM GLOVES (MFG. WOOD TING INDUSTRY) (K892752)Foodhandler, Inc.1989-06-06
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER (K890497)Monitor/Demlar1989-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K891421)Charone, Inc.1989-06-06
REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES (K891658)Regent Hospital Products1989-06-06
ARGENCO WLF (K893238)Argen Precious Metals, Inc.1989-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K891825)J & T Medical Products Co., Ltd.1989-06-06
ARGELITE 54+ (K893010)Argen Precious Metals, Inc.1989-06-06
ALMATEX EXAM GLOVES (MFG. CONCEPT RUBBER) (K893148)Healthgard Medical Products Ltd. Partnership1989-06-06
MODIFIED MRL NEUROPROBE SYSTEM V (K884869)Medical Research Laboratories, Inc.1989-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K892150)Dmp, Inc.1989-06-06
CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR. (K892907)Deringer-Ney, Inc.1989-06-06
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES (K891382)Ortho Diagnostic Systems, Inc.1989-06-06
NIL PATIENT EXAMINATION GLOVES (LATEX) (K891834)Glatex Sdn Bhd1989-06-06
PROLIFE PATIENT EXAMINATION GLOVES (LATEX) (K891660)B J L Glove (M) Sdn. Bhd.1989-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K891830)Perindustrian Masmuar Sdn Bhd1989-06-06
TELSTAR MODEL 1/3 ITE HEARING AID (K892457)Telstar Electronics, Inc.1989-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K891832)Integrasia Sdn Bhd1989-06-06
CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN (K884991)Datex Division Instrumentarium Corp.1989-06-06
TELSTAR MODEL C ITE HEARING AID (K892459)Telstar Electronics, Inc.1989-06-06
SUMMA PROTECH: DELTA SERIES PATIENT EXAM GLOVES (K891879)Summa Intl.1989-06-06
PATIENT EXAMINATION GLOVES (LATEX) (K891872)Orient Intl. Trading, Inc.1989-06-06
KDG ACETABULAR COMPONENT (K891262)Osteonics Corp.1989-06-06
DIGITAL SPOT IMAGING (DSI) (K893131)Philips Medical Systems, Inc.1989-06-06
PATIENT EXAMINATION GLOVES (K892985)Eac Rubber Industries (M) Sdn. Bhd.1989-06-06
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Every clearance here is in the API, with alerts when new ones post.