Atlas FDA

1989

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

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RecordFirmDate
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY (K896592)Ciba Corning Diagnostics Corp.1989-12-04
NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM (K895401)Rocky Mountain Orthodontics, Inc.1989-12-04
POLYETHER-RETARDER (K892412)Espe GmbH (Us)1989-12-04
AQUATREX UNDERWATER TREADMILL SYSTEM (K895104)Edmonds Medical Systems1989-12-04
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT (K896585)Medix Biotech, Inc.1989-12-04
SARNS INGANT MEMBRANE OXYGENATOR (K895393)3M Company1989-12-04
KULZER GLAS-IONOMER CEMENT (K892453)Kulzer, Inc.1989-12-04
BREVET FLOSS PICK (AUTOCLAVE STERILIZER) (K895958)Brevet, Inc.1989-12-04
STERILE SURGICAL DRAPES AND SHEETS (K896367)Clinitech, Inc.1989-12-04
GNATHOMAT ARTICULATOR (K896131)Ivoclar North America, Inc.1989-12-04
SITE 810E PHOTOCOAGULATOR AND ACCESSORIES (K895663)Site Microsurgical Systems, Inc.1989-12-04
ALCON FOLDING FORCEPS (K895434)Alcon Laboratories1989-12-04
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) (K896545)Sigma Chemical Co.1989-12-01
ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR (K896196)Orthoconcept, Inc.1989-12-01
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM (K895886)Biopro, Inc.1989-12-01
MILENIA(TM) HCG (MKCG1,5) (K895809)Diagnostic Products Corp.1989-12-01
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (K896483)Kallestad Diag, A Div. of Erbamont, Inc.1989-12-01
NEEDLEPOINT GUARD (K895831)Needlepoint Guard, Inc.1989-12-01
STETH-SHIELD(TM) (K892890)North East Technology1989-12-01
BLUNT NEEDLE PORT/I.V. PORT (K895480)Applied Medical Technologies1989-12-01
SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO. (K896163)Schneider Stent1989-12-01
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE (K883400)Abbott Laboratories1989-12-01
OSBON PERSONAL LUBRICANT (K895406)Osbon Medical Systems, Ltd.1989-12-01
STRAWBERRY SCENTED LATEX EXAMINATION GLOVES (K896135)Arista Latindo Industrial Ltd. P.T1989-12-01
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET (K894986)North American Sterilization & Packaging Co.1989-12-01
LATEX PATIENT EXAMINATION GLOVES (K895488)Zhong YI Latex Products Factory1989-12-01
IMMUNOCARD HCG II-S TEST KIT (K895912)Disease Detection International, Inc.1989-12-01
PATIENT EXAMINATION GLOVES (LATEX) (K891493)Cinderella Ent. Co., Ltd.1989-12-01
S.A.F. ACETABULAR CUP (K895157)Synergy Orthopaedics Intl., Inc.1989-12-01
ISOSCREEN-CK CONFIRMATORY KIT (K895870)Roche Diagnostic Systems, Inc.1989-12-01
INJECTION PORT II --- FOR INTERMITTENT INJECTION (K896291)The Medi-Dose Group1989-12-01
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST (K895362)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-01
PATIENT EXAMINATION GLOVES (K892279)Aek Rubber Product Sdn. Bhd.1989-12-01
OSBON PERSONAL LUBRICANT (K896207)Osbon Medical Systems, Ltd.1989-12-01
CARRINGTON DERMAL WOUND GEL (K894541)Carrington Laboratories, Inc.1989-11-30
16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE (K894879)R. J. Doyle, Inc.1989-11-30
STERILE FOLEY CATHETER (K890310)Kosan Far East Ent. , Ltd.1989-11-30
PORGES HOT BIOPSY FORCEPS (K896537)Porges Corp.1989-11-30
16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE (K894878)R. J. Doyle, Inc.1989-11-30
MODIFIED MODEL 535(TM) LUMINOMETER (K896117)Los Alamos Diagnostics1989-11-30
TON-SU'S VINYL EXAM GLOVES (K892584)Ton SU Co. , Ltd.1989-11-30
SPACELABS MODEL 90900 (K894093)Spacelabs, Inc.1989-11-30
ANGEION HEMOSTASIS VALVE INTRODUCER (K894446)Angeion Corp.1989-11-30
COHERENT HOLMIUM:YAG SURGICAL LASER (K895518)Lumenis, Inc.1989-11-30
SCD KNEE IMMOBILIZER (K895278)Kendall Healthcare Products Co. Div.Of Tyco Health1989-11-30
DEVILBISS MODEL 6300D (K896090)Devilbiss Health Care, Inc.1989-11-30
20GA X 7-1/2 THREADING BULLET POINT NEEDLE (K894881)R. J. Doyle, Inc.1989-11-30
IFA SENSIBAC CEFACLOR (K892721)Investigacion Farmaceutica S.A. DE C.V.1989-11-30
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP (K895966)Siemens Medical Solutions USA, Inc.1989-11-30
INFILTRATION PUMP SYRINGE (K894882)R. J. Doyle, Inc.1989-11-30
16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL (K894880)R. J. Doyle, Inc.1989-11-30
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN (K895352)Kendall Healthcare Products Co. Div.Of Tyco Health1989-11-29
SICKLE CELL SOLUBILITY TEST KIT (K895745)Simmler, Inc.1989-11-29
IMMUNOCARD STREP A TEST (K896109)Disease Detection International, Inc.1989-11-29
QUINTON MAHURKAR CATHETERS W/VITACUFF (K895440)Quinton, Inc.1989-11-29
ASPIRETTE ENDOCERVICAL ASPIRATOR (K895403)Unimar, Inc.1989-11-29
SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD (K895519)Personal Products Co.1989-11-29
KRONAMAX KUBE (K893903)Physicians Digital Co.1989-11-29
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) (K895959)Brevet, Inc.1989-11-29
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION (K895103)Gen-Probe, Inc.1989-11-29
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT (K895851)Beckman Instruments, Inc.1989-11-29
APEXIT ROOT CANAL SEALER (K893794)Williams Dental Co., Inc.1989-11-29
MODIFIED RUBAGEN (K896433)Biokit USA, Inc.1989-11-29
OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER (K895780)Datex Division Instrumentarium Corp.1989-11-29
TOWER SELF SEAL STERILIZATION POUCH (K895422)Baxter Healthcare Corp1989-11-29
OSSEODENT PROSTHETIC KIT (K895333)Celtrix Laboratories1989-11-29
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717 (K896392)Medtronic Vascular1989-11-28
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20 (K895428)A&D Engineering, Inc.1989-11-28
STANDARD CONDOM (K895530)Mayer Laboratories1989-11-28
ABBOTT INPERSOL CYCLER 1000 (K895336)Abbott Laboratories1989-11-28
LATEX PATIENT EXAMINATION GLOVES (K894999)Pushpaman Processors, Div. Kanjur Bleaching Co. PV1989-11-28
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (K895149)Shiley, Inc.1989-11-28
BIOBRANE(R) II (K896110)Sterling Drug, Inc.1989-11-28
LATEX PATIENT EXAMINATION GLOVES (K894713)Vailwood Products, L.P.1989-11-28
LONE STAR TRADING SURGICAL GLOVE (K896051)Lone Star Trading Pte. , Ltd.1989-11-28
MOP CATHETER (K891239)Bivona Medical Technologies1989-11-28
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (K895150)Shiley, Inc.1989-11-28
HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100 (K895430)Heraeus Lasersonics, Inc.1989-11-28
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650 (K895429)A&D Engineering, Inc.1989-11-28
CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) (K895446)Challenge Mfg., Inc.1989-11-27
MODIFIED AXOSTIM (K896368)Singer Medical Products, Inc.1989-11-27
D.L. SCOPE OPHTHALMOSCOPE (K896072)North American Medical Products, Inc.1989-11-27
LATEX PATIENT EXAMINATION GLOVES (K895491)Big Rubber Co., Ltd.1989-11-27
LATEX EXAMINATION GLOVES (K893366)Jinshan Caojing Latex Factory1989-11-27
TENZCARE ELECTRODE 6862 (K893793)3M Company1989-11-27
RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE (K896119)Rms Div.1989-11-27
REMINGTON TANFASTIC HANDHELD TANNING WAND (K895410)Remington Products Company, LLC1989-11-27
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F (K894168)Baxter Healthcare Corp1989-11-27
NEW FREEDOM ANYDAY PANTILINERS (K894229)Kimberly-Clark Corp.1989-11-27
NEEDLE SYRINGE DISPOSAL DEVICE (K896195)Advanced Medical Components, Inc.1989-11-27
MULTISPIRO (K895375)Medical Equipment Designs, Inc.1989-11-27
DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H (K893678)Medtronic Blood Systems, Inc.1989-11-27
EXUSORB(TM) DRY/WET DRESSING (K896176)Controlled Therapeutics Corp.1989-11-24
TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (K896369)Techmedica, Inc.1989-11-24
MEDISYSTEMS TRANSDUCER PROTECTOR (K895856)Medisystems Corp.1989-11-24
DEPUY (TM) TRUE COMPRESSION SCREW (K895389)Depuy, Inc.1989-11-24
MEDISONIC ULTRA-SONIC INHALER (K894961)Medisonic U.S.A., Inc.1989-11-24
DISPOSABLE DISC FILTER (K895419)The Medi-Dose Group1989-11-24
ANTI-THROMBOGENIC COATING FOR CATHETERS (K895191)Burron Medical, Inc.1989-11-24
ADMS MULTIPLANE RECTAL PROBE (K895359)Avalon Technology Corp.1989-11-22
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Track 1989 automatically

Every clearance here is in the API, with alerts when new ones post.