Atlas FDA

1990

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

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RecordFirmDate
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST (K901858)E.I. Dupont DE Nemours & Co., Inc.1990-06-12
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY (K900718)Roche Diagnostic Systems, Inc.1990-06-12
PROLACTIN (LACTOGEN) TEST SYSTEM (K901673)Baxter Healthcare Corp1990-06-12
COULTER UREA NITROGEN REAGENT (K902175)Coulter Corp.1990-06-12
POWERBASE II (PB2) (K901399)Nellcor, Inc.1990-06-12
ENZYMATIC THEOPHYLLINE REAGENT, #500-82 (K901510)Diagnostic Chemicals, Ltd. (Usa)1990-06-12
SORBA MODEL CIC-1000 W/NEW ELECTRODES (K901926)Sorba Medical Systems, Inc.1990-06-12
AP900/PRP MODULE AND ACCESSORIES, MODIFICATION (K893218)Electromedics, Inc.1990-06-12
C.P.R. LANDMARC (K900415)Can-Am Medical, Inc.1990-06-12
TENSOPLUS LITE (K901378)Smith & Nephew United, Inc.1990-06-12
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM (K896467)Medisense, Inc.1990-06-12
7620 REMOTE CENTRAL STATION REPEATER (K901884)Marquette Electronics, Inc.1990-06-12
ACS ADVANCED CONCEPT GUIDE WIRE (K900386)Advanced Cardiovascular Systems, Inc.1990-06-12
REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) (K901463)Helena Laboratories1990-06-12
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE (K901565)Applied Vascular Devices, Inc.1990-06-12
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (K901250)Shiley, Inc.1990-06-11
RX ROCKER TRIUMPH, JR. WHEELCHAIR (K902440)The RX Rocker Corp.1990-06-11
ESCORT MODEL 300 (K902060)Medical Data Electronics1990-06-11
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN (K901439)Telemed Systems, Inc.1990-06-11
BIOPSY FORCEPS (NON-RIGID) (K901339)Applied Medical Technologies1990-06-11
CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER (K902452)Berner Assoc., Inc.1990-06-11
AUSONICS 5000 (K896714)Ausonics Pty , Ltd.1990-06-11
TITAN ZODIAC ADJUSTING TABLE (K902466)Titan Tables1990-06-11
INSITE STEERABLE GUIDEWIRE (K901224)Lake Region Mfg., Inc.1990-06-11
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (K901249)Shiley, Inc.1990-06-11
TITAN HERCULES ADJUSTING TABLE (K902465)Titan Tables1990-06-11
MEDITHERM (K894152)Medical Equipment Designs, Inc.1990-06-11
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM (K900494)Synectics-Dantec1990-06-11
CORPAK GASTROSTOMY TUBE (K901501)Corpak Co.1990-06-11
TRANS/R - FP(3) (K900016)CIVCO Medical Instruments Co., Inc.1990-06-11
DYNATRON 330 BODY COMPOSITION ANALYZER (K900321)Dynatronics Laser Corp.1990-06-11
CAAS UNICOMPARMENTAL KNEE SYSTEM (K900619)Techmedica, Inc.1990-06-11
KINAMED CEMENTED ATH-LONG STEM (K902073)Kinamed, Inc.1990-06-08
NIDEK RT-1200S (MARCO TRS-1200) (K901513)Nidek, Inc.1990-06-08
TBD TENS REUSABLE ELECTRODE (K902195)Empi1990-06-08
PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY (K901081)Vlv Associates, Inc.1990-06-08
DURACATH (K901133)Impra, Inc.1990-06-08
NON-PRESCRIPTION SUNGLASSES (K901036)The Bonneau Co.1990-06-08
CORE DISPOSABLE TROCARS (K901407)Core Dynamics, Inc.1990-06-08
MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT (K902366)Synectics-Dantec1990-06-08
NEOSERV 824 (K900729)Burdick Corp.1990-06-08
PAPILLOTOME (K901434)Telemed Systems, Inc.1990-06-08
RMI CARDIOPLEGIA DELIVERY KITS (K901231)Research Medical, Inc.1990-06-08
HOME URODATA SYSTEM(TM) (K900770)Biodan Medical Systems, Ltd.1990-06-08
VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR (K901046)Vlv Associates, Inc.1990-06-08
KINAMED CEMENTED CTH STEM (K902074)Kinamed, Inc.1990-06-08
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000 (K901686)Nidek, Inc.1990-06-08
MESAMIV RECORDER (K901466)Madaus Medtec, Inc.1990-06-08
AMBU LIFE KEY AND AMBU RES-CUE KEY (K900260)Ambu, Inc.1990-06-08
ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE (K902282)Ncl Corp.1990-06-07
MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (K902019)Gynescope Corp.1990-06-07
CHEMOPLUS GLOVE (K901411)Biosafety Systems, Inc.1990-06-07
CROAK OVARIAN BIOPSY FORCEP (K902049)Gynescope Corp.1990-06-07
NONIMPLANTED ELECTRICAL CONTINENCE DEVICE (K891007)Tridak Division of Indicon, Inc.1990-06-07
CARRINGTON WOUND DRESSING (K902345)Carrington Laboratories, Inc.1990-06-07
BEHRING LASER NEPHELOMETER (K761234)Behring Diagnostics, Inc.1990-06-07
MINT SCENTED CONDOMS (K900679)Schmid Laboratories, Inc.1990-06-07
RUBBER CONDOM (NON-COLORED) (K896987)Hankook Latex Gongup Co., Ltd.1990-06-06
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS (K901997)Comet Ltd. C/O Radiology Resources, Inc.1990-06-06
SUPER STRENGTH DENTURE ADHESIVE CREAM (K901938)Teledyne Getz1990-06-06
BIPOLARD POLYPECTOMY SYSTEM (TM) (K901302)Medical Devices, Inc.1990-06-06
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE (K901362)Automatic Liquid Packaging, Inc.1990-06-06
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B (K901573)Syva Co.1990-06-06
PROMISE ABSORBENT PROTECTIVE PAD (K900421)Scott Health Care1990-06-06
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (K902266)Phoenix Diagnostics, Inc.1990-06-06
REP(R) IMMUNOFIX (K901805)Helena Laboratories1990-06-06
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 (K902123)Em Diagnostic Systems, Inc.1990-06-06
HYPODERMIC SYRINGE LUER LOK (K901203)Ware-Medics Glass Works, Inc.1990-06-06
BLOOD GAS CONTROLS (K901985)Phoenix Diagnostics, Inc.1990-06-06
WOUND TREATMENT KIT (K901109)Orion Life Systems, Inc.1990-06-06
SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM (K896630)Atos Medical AB1990-06-06
RUBBER CONTRACEPTIVE (CONDOM) (K896142)Guangzhou No. 11 Rubber Factory1990-06-06
PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE (K901796)Component Equipment Mfg., Inc.1990-06-06
RUBBER, DENTAL DAM (NON-STERILE) (K901236)Naturub Sdn. Bhd.1990-06-06
HORIZON SURGICAL LIGATING AND MARKING CLIP (K901303)Horizon Surgical, Inc.1990-06-05
LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE (K896850)Lima Intl. Corp.1990-06-05
LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. (K901128)Lasercomp1990-06-05
CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (K896648)Concept, Inc.1990-06-05
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE (K901429)Telemed Systems, Inc.1990-06-05
L.M.S. SELF-DETACHABLE BROACH WITH STOP (K901273)Med-Tek Corp.1990-06-05
IRRIGATION AND SUCTION APPARATUS (K900430)Acorn Group, Inc.1990-06-05
GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II (K901369)Sterling Drug, Inc.1990-06-05
EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS (K901204)Niic U.S.A., Inc.1990-06-05
CONDOM (RUBBER) CONTRACEPTIVE (K901416)Aladan Corp.1990-06-04
SPEC(TM) EXTRACTION CARTRIDGE (K901694)Toxi-Lab, Inc.1990-06-01
LATEX EXAMINATION GLOVES (K900980)Sinochem (Usa), Inc.1990-06-01
NA LATEX MYOGLOBIN TEST (K902154)Behring Diagnostics, Inc.1990-06-01
ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) (K896998)S.P.K. Technology, Inc.1990-06-01
MODIFIED NON-STERILE LATEX EXAMINATION GLOVES (K902181)Aladan Corp.1990-06-01
600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET (K901753)Chartermed, Inc.1990-06-01
CP-3 DENTAL POLISHING MATERIAL (K901973)Gresco Products, Inc.1990-06-01
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. (K901084)Healthdyne Cardiovascular, Inc.1990-06-01
RIGID URETEROSCOPE (K901214)Applied Urology, Inc.1990-06-01
URESIL TRU-CLOSE DRAINAGE BAG (K901844)Uresil Corp.1990-06-01
MODIFIED STERILE LATEX EXAMINATION GLOVES (K902182)Aladan Corp.1990-06-01
FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR (K901996)Filtertek, Inc.1990-06-01
PATHODX PYR KIT (K902037)Diagnostic Products Corp.1990-06-01
ENTERA-FLO FEEDING TUBE (K901130)Fresenius Pharma1990-06-01
CT-1000A SYSTEM (K896779)Bio-Monitor, Inc.1990-06-01
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE (K900488)American Orthodontics1990-06-01
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Every clearance here is in the API, with alerts when new ones post.