Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODIFIED QM300 RHEUMATOID FACTOR TEST (K902462)Kallestad Diag, A Div. of Erbamont, Inc.1990-06-21
BILIARY BALLOON DILATOR (K901432)Telemed Systems, Inc.1990-06-21
DATASCOPE SLIDEWIRE(TM) (K901347)Datascope Corp.1990-06-21
ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY (K902269)Seabrook Medical Systems, Inc.1990-06-21
SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (K897141)Stuart1990-06-21
SPECTACLE FRAME (K900732)Seiko Corp.1990-06-20
CONTINUUM KNEE SYSTEM (CKS) (K901457)Techmedica, Inc.1990-06-20
MICROMATE 196 MODEL A961960 (K901808)Packard Instrument Co., Inc.1990-06-20
SUNGLASS, NON-PRESCRIPTION (K900764)Seiko Optical Products of America, Inc.1990-06-20
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. (K901397)Gen-Probe, Inc.1990-06-20
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE (K902010)Visitec Co.1990-06-20
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER (K901481)Nidek, Inc.1990-06-20
ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE (K901134)Fresenius Pharma1990-06-20
ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 (K901735)Micro-Aire Surgical Instruments, Inc.1990-06-20
PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE (K901531)Pioneering Technologies, Inc.1990-06-20
CANNULATED INTERFERENCE SCREW SYSTEM (K901616)Smith & Nephew Dyonics, Inc.1990-06-20
SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG (K900482)Axon Systems, Inc.1990-06-20
AMCATH COAGULATION PROBE (K902555)Intl. Medical, Inc.1990-06-20
DRYSLIDE, BETA-LACTAMASE (K901784)Difco Laboratories, Inc.1990-06-20
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 (K901475)Baxter Healthcare Corp1990-06-20
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (K902028)Norfolk Scientific, Inc.1990-06-20
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET (K901934)Eastman Kodak Company1990-06-20
ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) (K902168)Micro-Aire Surgical Instruments, Inc.1990-06-20
REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER (K902562)Lca, Inc.1990-06-20
SUNGLASSES STYLE #(1137) (K901570)Zaks Stores, Inc.1990-06-20
SUNGLASSES STYLE #(CM-1989) (K901571)Zaks Stores, Inc.1990-06-20
ASI HEMOSTASIS CATHETER (K901336)Advanced Surgical Intervention, Inc.1990-06-20
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED (K901202)Carter Products1990-06-19
RX ROCKER WHEELCHAIR (K902438)The RX Rocker Corp.1990-06-19
SUNGLASSES STYLE #(70116) (K901572)Zaks Stores, Inc.1990-06-19
PULSE OXIMETRY MODULE (K901071)Marquette Electronics, Inc.1990-06-19
RX ROCKER TRIUMPH WHEELCHAIR (K902439)The RX Rocker Corp.1990-06-19
COLORADO COLOR IMAGING RECORDER (K902230)Honeywell, Inc.1990-06-19
TAMCENAN OCULAR EXPLANTS AND BANDS (K902308)Tamcenan Corp.1990-06-19
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE (K901437)Telemed Systems, Inc.1990-06-18
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 (K896874)Dantec Medical, Inc.1990-06-18
CONCENTRIC ELECTRODE TYPE #13R01, 13R02 (K895460)Dantec Electronics, Inc.1990-06-18
ZIMMON PAPILLOTOME (K901443)Wilson-Cook Medical, Inc.1990-06-18
TELEMED ERCP CANNULA (K901431)Telemed Systems, Inc.1990-06-18
MODIFIED DELFIA ESTRADIOL KIT (K902358)Pharmacia, Inc.1990-06-18
CUDA SURGICAL LIGHT (K901491)Cuda Products Co.1990-06-18
AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES (K901138)Boehringer Laboratories1990-06-18
BRONCHIAL CYTOLOGY BRUSH (K901436)Telemed Systems, Inc.1990-06-18
MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT (K894241)Directed Energy, Inc.1990-06-18
MAX TRANSPORT VENTILATOR (K900465)Hamilton Medical, Inc.1990-06-18
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE (K902380)Baxter Healthcare Corp1990-06-18
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL (K897194)Baxter Healthcare Corp1990-06-18
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (K902259)Orthomet, Inc.1990-06-18
DESERET OPTIMA INTRAVASCULAR CATHETER (K900116)Deseret Medical, Inc.1990-06-18
PHARMASEAL EPIDURAL CATHETER (K896712)Baxter Healthcare Corp1990-06-18
SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET (K901729)Ryan Medical, Inc.1990-06-18
WAKO(TM) MICRO-ALBUMIN (K902216)Wako Chemicals USA, Inc.1990-06-18
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE (K902336)Ciba Corning Diagnostics Corp.1990-06-18
IONOMETER EH-HK AND ACCESSORIES (K901041)Fresenius USA, Inc.1990-06-18
LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 (K901809)Lumiscope Co., Inc.1990-06-18
J&S HDL CHOLESTEROL PRECIPITATING REAGENT (K900218)J.S. Medical Assoc.1990-06-18
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE (K901428)Telemed Systems, Inc.1990-06-18
INVACARE EXTENDED CARE NURSING HOME BED (K900151)Invacare Corp.1990-06-18
ZEFAZONE SUSCEPTIBILITY TEST DISKS (K902082)Difco Laboratories, Inc.1990-06-15
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE (K902083)Helena Laboratories1990-06-15
DOBBHOFF(R) POLYPECTOMY SNARE (K901322)Biosearch Medical Products, Inc.1990-06-15
WATER PIK(R) W/ADD'L CLAIMS (K900547)Teledyne Water Pik1990-06-15
SILISTOR CERAMIC AND RESIN REPAIR SYSTEM (K901697)Kulzer, Inc.1990-06-15
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT (K900546)Baxter Healthcare Corp1990-06-15
FORMASIL(R)A POLYVINYL SILOXANE LINE (K901681)Kulzer, Inc.1990-06-15
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 (K901414)Helena Laboratories1990-06-15
CARDIOTHORACIC RULER (K902378)Devcom, Inc.1990-06-14
DANEK PRECISION ROD SET (K896254)Danek Medical, Inc.1990-06-14
EXPANDACEL NASAL TAMPONS (K900171)Surgitrend, Ltd.1990-06-14
PASSAGE AIRWAY SPLINT (K901307)Invotec International, Inc.1990-06-14
BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT (K900518)Helix Medical, Inc.1990-06-14
ARVEE APNEA MONITOR, MODEL 4800 (K900730)Arvee Medical, Inc.1990-06-14
CUSTOM ITE HEARING AID MODEL: H (K902352)Oticon Corp.1990-06-14
RETRAX SAFETY SYRINGE (K901508)Retrax, Inc.1990-06-14
(EYEGLASS) FRAMES AND SUNGLASSES (K901167)Optique Marquis, Div. Sugerose, Inc.1990-06-14
JAHN VENTILATION TUBE (K900267)Smith & Nephew Richards, Inc.1990-06-14
CUSTOM ITE HEARING AID MODELS F AND L (K902353)Oticon Corp.1990-06-14
INVOTEC BI-VALVE SPLINT (K901306)Invotec International, Inc.1990-06-14
ULTRASTAT NASAL CATHETER (K901310)Invotec International, Inc.1990-06-14
FRAME, SPECTACLE (K897091)Pt Midas Surya Optical Co.1990-06-14
NUBALOO(R) SUNGLASSES (K901160)Blublocker Corp.1990-06-14
CARAGLAS XTRA SYNTHETIC CASTING TAPE (K896634)Buckman Co., Inc.1990-06-14
CUSTOM ITE HEARING AID MODELS C AND M (K902351)Oticon Corp.1990-06-14
BARTON-MAYO TRACHEOSTOMA BUTTON (K901377)Medical Innovations International, Inc.1990-06-14
INVOTEC SEPTAL BUTTON (K901366)Invotec International, Inc.1990-06-14
LEG EEZE (K901931)Jereva, Inc.1990-06-14
TITAN GLADIATOR ADJUSTING TABLE (K902549)Titan Tables1990-06-13
TITAN APOLLO AND NOVA ADJUSTING TABLES (K902234)Titan Tables1990-06-13
MODULAR FLEXIBLE DRILLING SYSTEM (K901165)Dalton Technology, Inc.1990-06-13
DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER (K901166)Dalton Technology, Inc.1990-06-13
COULTER DIRECT BILIRUBIN (K902199)Coulter Corp.1990-06-12
COULTER SERUM IRON/UIBC REAGENT (K902173)Coulter Corp.1990-06-12
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS (K902095)Phoenix Diagnostics, Inc.1990-06-12
F-20 TOTAL HIP PROSTHESIS (K901480)Med-Tek Corp.1990-06-12
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) (K902155)Hichem Diagnostics1990-06-12
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS (K902267)Phoenix Diagnostics, Inc.1990-06-12
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 (K901402)Telectronics Pacing Systems, Inc.1990-06-12
MODIFIED OPUS PHENOBARBITAL TEST SYSTEM (K901537)Pb Diagnostic Systems, Inc.1990-06-12
ABSORBABLE GAUZE DRAPE (K901465)Ulti-Med Intl., Inc.1990-06-12
COULTER CARBON DIOXIDE REAGENT (K902229)Coulter Corp.1990-06-12
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Track 1990 automatically

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