Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODEL GS-4700 COMMON DUCT STONE REMOVING KIT (K910671)Solos Endoscopy, Inc.1991-05-10
DOCUMENT REFLECTANCE II LINEARITY TEST SET (K910440)Casco Standards1991-05-10
GLOVE-N-GEL AMNIOTOMY KIT (K910518)Epcom Medical Systems, Inc.1991-05-09
MODEL SW-103 SOLITANS STIMULATOR (K904264)Medical Consultants Intl. , Ltd.1991-05-09
TROCAR ACCESS SHEATH (K905471)Cook Ob/Gyn1991-05-09
RAICHEM SPIA C3 REAGENT (K911900)Reagents Applications, Inc.1991-05-09
GRAVITY PLUS CONTROLLER/COMPOUNDER (K902853)Fergy Corp.1991-05-09
LIFELINER SURGICAL GLOVE (K910941)Depuy-Raynham1991-05-09
BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR (K910663)Mdt Corp., Inc.1991-05-09
PERRY(R) ENCORE CHEMOTHERAPY GLOVE (K911633)Smith & Nephew Perry1991-05-09
NHS 2009SP HEARING AID (K911174)Magnatone Hearing Aid Corp.1991-05-09
POWER SCAN 1000 (K910802)Webb Research, Inc.1991-05-09
CT SYTEC 4000 (K911387)GE Medical Systems1991-05-09
POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM (K911275)Positron1991-05-09
CMI TENDER TOUCH VE #303TT AND 404TT (K910788)Challenge Mfg., Inc.1991-05-09
RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (K904237)Innovative Medical Technologies, Inc.1991-05-09
LASER-35 (K910200)Endo Technic Corp.1991-05-09
RAICHEM SPIA C4 REAGENT (K911899)Reagents Applications, Inc.1991-05-09
NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS (K911182)Magnatone Hearing Aid Corp.1991-05-09
EDWARDS-WALLACE BOURNE HALL CATHETER (K910577)Marlo Surgical Technology1991-05-09
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN (K911392)Alamar1991-05-08
QUALTEX SUTURE BOOTIES (K911895)Deroyal Industries, Inc.1991-05-08
TRO-GARD (K910678)Conmedcorp1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME) (K911391)Alamar1991-05-08
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM (K911060)Immunomatrix1991-05-08
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION (K910754)Hewlett-Packard Co.1991-05-08
OMNICATH IMPLANTED CATHETER AND DEPOT (K911775)Omnitron Intl., Inc.1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM) (K911390)Alamar1991-05-08
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM) (K911389)Alamar1991-05-08
INFLATE-A-CUFF #7014 (K910903)Pa Medical Corp.1991-05-08
ROBICSEK PROBE/RETRACTOR (K910682)Bio-Vascular, Inc.1991-05-08
QUALTEX SKIN STAPLE EXTRACTOR (K911204)Deroyal Industries, Inc.1991-05-08
DISPOSABLE ANESTHESIA BREATHING CIRCUIT (K910896)Specialty Packaging Producs, Inc.1991-05-08
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A (K905571)Biomedical Life Systems, Inc.1991-05-08
PROPAQ 102EL, 104EL AND 106EL (K910882)Protocol Systems, Inc.1991-05-08
SYSTEMATE CREATININE (EPOS APPLICATION) #65413 (K905658)Em Diagnostic Systems, Inc.1991-05-08
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (K911898)Reagents Applications, Inc.1991-05-08
ROCHE APOLIPOPROTEIN STANDARD (K910553)Roche Diagnostic Systems, Inc.1991-05-08
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER (K911141)Hemocue, Inc.1991-05-08
CARDIOCAP DR-124 RECORDER (K910620)Datex Division Instrumentarium Corp.1991-05-07
A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER (K905114)Research Consultants, Inc.1991-05-07
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS (K911579)Starkey Laboratories, Inc.1991-05-07
DISPOSABLE RETRACTABLE NEEDLE SYRINGE (K910731)Safe Tech Medical Products, Inc.1991-05-07
MODIFIED PK TP CONTROL (K911266)Olympus Corp.1991-05-07
PERMANENT PACING LEAD (K905300)Oscor Medical Corp.1991-05-07
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST (K911849)General Biometrics, Inc.1991-05-07
IMMUNOWELL SM ANTIBODY TEST (K911851)General Biometrics, Inc.1991-05-07
OSCOR MEDICAL CORP. PERMANENT PACING PAD (K905182)Oscor Medical Corp.1991-05-07
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST (K911850)General Biometrics, Inc.1991-05-07
GENESIS I AUTOMATED CELL COUNTER (K910679)Alicia Diagnostics, Inc.1991-05-07
QBC AUTOREADER (K910834)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-05-07
ROCHE REAGENT FOR APOLIPOPROTEIN B (K910552)Roche Diagnostic Systems, Inc.1991-05-07
MODEL 5311B A-V PACING SYSTEM ANALYZER (K910595)Medtronic Vascular1991-05-07
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK (K910861)Daig Corp.1991-05-07
CARD GUARD-3000 ECG TELEPHONE ADAPTER (K910450)Medtech Industries, Inc.1991-05-07
MET-ETCH (K910813)Gresco Products, Inc.1991-05-07
TRIOS 02 (K905087)Biotronik, GmbH & Co.1991-05-07
BARD(R) ENDOCARDIAL BALLOON ARRAY (K911140)C.R. Bard, Inc.1991-05-07
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR (K905049)Quidel Corp.1991-05-07
DISPOSABLE PATIENT CABLE (K910645)Diag Corp.1991-05-07
IMMUNOWELL RNP/SM ANTIBODY TEST (K911848)General Biometrics, Inc.1991-05-07
ROCHE REAGENT FOR APOLIPOPROTEIN A-1 (K910551)Roche Diagnostic Systems, Inc.1991-05-07
PYLORI STAT TEST KIT (K904738)Whittaker Bioproducts, Inc.1991-05-07
PYLORI-G FIAX TEST KIT (K905468)Whittaker Bioproducts, Inc.1991-05-07
GLOBALCARE MICRO 11 AND MICROCARE (TENS) (K903394)Globalcare Intl., Inc.1991-05-06
OLYMPUS PK-TP ABSORBENT KIT (K905038)Fujirebio America, Inc.1991-05-06
MULTIPLE, SURGICAL DRAPE PACK (K911132)Central Georgia Ancillary Health Systems1991-05-06
CLEARBLUE EASY (K911566)Unipath , Ltd.1991-05-06
HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM (K910500)Howmedica Corp.1991-05-06
SPECTACLE FRAME (K911332)Australian Optical Co., Inc.1991-05-06
FHT (FECAL HEME TEST) (K905782)Aerscher, Inc.1991-05-06
CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. (K910496)Heraeus Lasersonics, Inc.1991-05-06
FREEDOM MARK III SURGICAL HELMET SYSTEM (K910515)Stackhouse Assoc.1991-05-06
TOUCHLESS II INTERMITTENT CATHETER (K910653)C.R. Bard, Inc.1991-05-06
PTI STERNAL CLOSURE WIRE SUTURE (K910067)Pioneering Technologies, Inc.1991-05-06
SPIROSCOPE (K905480)Grandcor Medical Systems1991-05-06
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY (K910564)Menlo Care, Inc.1991-05-06
BIOTROL PROTEIN MULTILEVEL STANDARDS (K910721)Biotrol, USA, Inc.1991-05-06
OPTHLAMIC FRAMES (K910951)United Optical, Spa1991-05-06
STATIM CASSETTE AUTOCLAVE (K910241)Scican1991-05-03
OHMEDA 7810 ANESTHESIA VENTILATOR (K910847)Ohmeda Medical1991-05-03
MOSS P.E.G. TRAY (K910911)Moss Medical Products1991-05-03
OHMEDA MODULUS CD ANESTHESIA SYSTEM (K905635)Ohmeda Medical1991-05-03
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS (K905235)Percussionaire Corp.1991-05-03
VARIAN ELECTRONIC PORTAL IMAGING SYSTEM (K901932)Varian Assoc., Inc.1991-05-03
ALADAN LATEX MEDICAL GLOVE (K911774)Aladan Corp.1991-05-03
MENTOR LUBRICATING JELLY (K910790)Mentor Corp.1991-05-03
SAFETY NEEDLE SHEATH, MODIFICATION (K911037)Concord/Portex1991-05-03
Z XT RADIATION THERAPY TREATMENT TABLE (K910971)Siemens Medical Laboratories, Inc.1991-05-03
HOT BIOPSY FORCEPS (K910964)Symbiosis Corp.1991-05-02
MODEL 205 SHOCK-TRODE (K910661)Cardiotronics, Inc.1991-05-02
MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 (K911160)Mentor O & O, Inc.1991-05-02
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS (K910499)Vitek Systems, Inc.1991-05-01
OPHTA SIL (R), LACHRYMAL INTUBATION SETS (K911109)G.W.B. Intl., Ltd.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III (K911168)Analytical Control Systems, Inc.1991-05-01
SUNGLASSES (K910415)K.M Optical Co.1991-05-01
SRI T3 IMMOENZYMETRIC ASSAY (K910737)Serono-Baker Diagnostics, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III (K911178)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I (K911169)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II (K911167)Analytical Control Systems, Inc.1991-05-01
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Every clearance here is in the API, with alerts when new ones post.