Atlas FDA

1989

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

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RecordFirmDate
GENNY DENNY IV SHIELD (K885342)Mercury Enterprises, Inc.1989-03-30
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR (K890724)Bear Medical Systems, Inc.1989-03-30
PATIENT EXAMINATION GLOVE (K890591)Marcon Rubber Industry Sdn. Bhd.1989-03-30
MICRODELTA II (K885242)Siemens Gammasonics, Inc.1989-03-30
VITAACCESS CATHETER INTRODUCER KIT (K890435)Vitaphore Corp.1989-03-29
GREENE-ARMYTAGE HEMOSTATIC FORCEPS (K891397)Zinnanti Surgical Instruments, Inc.1989-03-29
PHOSPHORIC-ACID ETCHING GEL (K890140)Centrix, Inc.1989-03-29
CAMPION CERVICAL HOOK (K891349)Simpson/Basye, Inc.1989-03-29
ITE HEARING AID PARKER/TECHNITONE, MODEL PA (K884997)Hearing Enhancement Center, Inc.1989-03-29
BEHIND-THE-EAR HEARING AID MODEL 303 ASP (K891249)Siemens Hearing Instruments, Inc.1989-03-29
BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC (K891247)Siemens Hearing Instruments, Inc.1989-03-29
NEWPORT CERVICAL MANIPULATOR (K891350)Simpson/Basye, Inc.1989-03-29
REID ENDOCERVICAL SPREADER (K891347)Simpson/Basye, Inc.1989-03-29
PATIENT EXAMINATION GLOVES (LATEX) (K891378)Sri Johani Sdn. Bhd.1989-03-29
BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I (K891248)Siemens Hearing Instruments, Inc.1989-03-29
PATIENT EXAMINATION GLOVES (LATEX) (K891511)Oon Corp. Resources1989-03-29
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE (K891011)Resound Corp.1989-03-29
MULTI-PURPOSE CONTROL SYSTEM (K885140)Colliers Sterilizer Sales & Service Co., Inc.1989-03-29
AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) (K891298)Medi Tex, Inc.1989-03-29
COMPLE-SAFE VINYL EXAMINATION GLOVES (K891369)Universal Gloves Corp.1989-03-29
BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) (K891366)Mdt Corp., Inc.1989-03-29
TOITU DOPPLER FETUS DETECTOR, FD-400D (K890139)Toitu of America, Inc.1989-03-29
RUBBER DAM (K890667)Cost Rite Health Products, Inc.1989-03-29
AQUADERM (K885205)Laivan Corp.1989-03-29
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS (K890494)Macrochem Corp.1989-03-29
BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC (K891250)Siemens Hearing Instruments, Inc.1989-03-29
SAFECON CONDOMS W/SPERMICIDAL LUBRICANT (K883524)Quality Synthetics Intl, Inc.1989-03-29
UTERINE CLAMPS (K891402)Zinnanti Surgical Instruments, Inc.1989-03-29
P.F.C.(TM) MODULAR KNEE SYSTEM (K884796)Johnson & Johnson Professionals, Inc.1989-03-29
ALADAN STERILE LATEX MEDICAL GLOVE (K890880)Aladan Corp.1989-03-29
CORSON MYOMA GRASPING FORCEPS (K891399)Zinnanti Surgical Instruments, Inc.1989-03-29
PATIENT EXAMINATION GLOVES (K890816)Dan Co., Ltd.1989-03-29
PATIENT EXAMINATION GLOVES (LATEX) (K891425)Encore Technology, Inc.1989-03-29
PATIENT EXAMINATION GLOVES (LATEX) (K891291)Cp Products, Inc.1989-03-29
GELLHORN PESSARY 33410 VARIOUS SIZES (K890565)Medi-Source, Inc.1989-03-29
VINYL PATIENT EXAMINATION GLOVE (K890985)Am Gloves Co., Ltd.1989-03-29
BRACE (ORAFIX SPECIAL) (K890290)Norcliff Thayer, Inc.1989-03-29
HUNTLEIGH DYNAMIC FLOTATION SYSTEM (K890012)Huntleigh Technology, Inc.1989-03-29
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (K890997)Atlantic Wholesale, Inc.1989-03-28
COTUBE(TM) TSH IRMA (K890802)Bio-Rad1989-03-28
KODAK EKTACHEM 500 ANALYZER (K890928)Eastman Kodak Company1989-03-28
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS (K890411)Intermedics, Inc.1989-03-28
VS-1 MODEL NUMBER 251K PULSE GENERATOR (K885267)Pacesetter Systems1989-03-28
STAR 36 (K890066)Transworld X-Ray Corp.1989-03-28
CENTURION CIRCLAMP (K890897)Tri-State Hospital Supply Corp.1989-03-28
MAGNESIUM REAGENT (K891355)Medical Analysis Systems, Inc.1989-03-28
KODAK EKTACHEM 750 SERIES ANALYZER (K890929)Eastman Kodak Company1989-03-28
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS (K890412)Intermedics, Inc.1989-03-28
QMS(TM) - THEOPHYLLINE (K885263)Seradyn, Inc.1989-03-28
VENTREX COATED TUBE HCG (K890549)Ventrex Laboratories, Inc.1989-03-28
TECHNICON DAX(TM) SYSTEM (K885203)Technicon Instruments Corp.1989-03-28
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE (K884184)Sigma Diagnostics, Inc.1989-03-28
KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0 (K890927)Eastman Kodak Company1989-03-28
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE (K885272)Sigma Chemical Co.1989-03-28
1570 - FETAL BLOOD SAMPLING KIT (K891388)Transidyne General Corp.1989-03-28
VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT (K890840)Adi Diagnostics, Inc.1989-03-27
PERITONEAL CATHETERS WITH AN ADDED FUNCTION (K890288)Quinton, Inc.1989-03-27
FRANKLIN COLLECTOR(R) (K884612)Franklin Diagnostics, Inc.1989-03-27
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) (K890530)Behring Diagnostics, Inc.1989-03-27
UBI MAGIWEL CMV IGG QUANTITATIVE (K883399)United Biotech, Inc.1989-03-27
ANAEROBIC MIC PANEL (K884831)Microtech Medical Systems, Inc.1989-03-27
ABBOTT TESTPACK(TM) D-DIMER (K890422)Abbott Laboratories1989-03-27
CYTOMEGALOVIRUS IGG EIA KIT (K880433)De Ferris Laboratories, Inc.1989-03-27
GAMMA-GLUTAMYLTRANSFERASE (K890312)American Monitor Corp.1989-03-24
ABBOTT CLINICAL CHEMISTRY REAGENT ALP (K890521)Abbott Laboratories1989-03-24
ABBOTT OVULATION PREDICTOR TEST (K890510)Abbott Laboratories1989-03-24
O-020 LASER INDIRECT OPHTHALMOSCOPE (K890787)Hgm Medical Laser Systems, Inc.1989-03-24
TEXMED LATEX EXAMINATION GLOVE (K891120)Transcorp1989-03-24
ACCESSORY TO EYEDROP GUIDE (K884974)Suredrop, Inc.1989-03-24
LATEX EXAMINATION GLOVE (K890462)C.R. Trading, Inc.1989-03-24
PATIENT EXAMINATION GLOVES (LATEX) (K891424)Oon Corp. Resources1989-03-24
KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT (K890573)Kenlor Industries, Inc.1989-03-24
INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM (K890509)Biophysic Medical, Inc.1989-03-24
HEXASCAN SCANNER HANDPIECE (K890865)Metatech Corp.1989-03-24
PATIENT EXAMINATION GLOVES (LATEX) (K891434)Sime Darby USA1989-03-24
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES (K890908)Baxter Healthcare Corp1989-03-24
PATIENT EXAMINATION GLOVES (LATEX) (K891446)Felda Rubber Corp.1989-03-23
PATIENT EXAMINATION GLOVES (LATEX) (K891181)Behn Meyer & Co. (M) Sdn Bhd1989-03-23
TURBO AIR COMPRESSOR 8000 (K883829)Necon Medical, Inc.1989-03-23
BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR (K884849)Moe1989-03-23
LATEX EXAMINATION GLOVES (K891206)Charug Fang Ent.1989-03-23
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA (K890147)Rich-Mar Corp.1989-03-23
POLYMER ADHESIVE BANDAGE (K883391)Marion Laboratories, Inc.1989-03-23
STANDING DANI WHEELSTAND (K890602)Davis Positioning Systems, Inc.1989-03-23
PATIENT EXAMINATION GLOVES (LATEX) (K891443)Sukas Sdn Bhd1989-03-23
ATS DOBELL & O'CONNOR'S IODINE (K890861)Alpha-Tec Systems, Inc.1989-03-23
NU-DERM HYDROCOLLOID DRESSING (K890545)Johnson & Johnson Patient Care, Inc.1989-03-23
PATIENT EXAMINATION GLOVES (STERILE & NON-STERILE) (K890857)Health & Hospital Intl.1989-03-23
PATIENT EXAMINATION GLOVES (LATEX) (K891447)Lily Corp.1989-03-23
PATIENT EXAMINATION GLOVE (LATEX) (K891170)Ching Pax Trading Co., Ltd.1989-03-23
UNSTERILE PATIENT EXAMINATION GLOVE (K890627)Aladan Corp.1989-03-23
GRAND COOLING MACHINE (K891152)Kinetic Concepts, Inc.1989-03-23
NE-CHECK (K890767)Streck Laboratories, Inc.1989-03-23
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A (K885316)Hewlett-Packard Co.1989-03-23
REHABOT-YM (K890838)Imex Health, Inc.1989-03-23
MODEL ESP-200 MAMMOGRAPHIC SYSTEM (K884345)Acoma Medical Imaging, Inc.1989-03-23
LATEX EXAMINATION GLOVES (K890847)Prime Merit Intl. Corp.1989-03-23
TECHNOMED PULSOLITH LASER SYSTEM (K890436)Teknomed, Inc.1989-03-23
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS (K890881)Teca, Inc.1989-03-23
PATIENT EXAMINATION GLOVE, VINYL (K891067)Sun Flower Gloves Co., Ltd.1989-03-23
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Every clearance here is in the API, with alerts when new ones post.