Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TOTAL BILIRUBIN STANDARD CALIBRATOR (K872263)Wako Chemicals USA, Inc.1987-07-22
ALTERNATE SUPPLIERS FOR TENS ELECTRODE (K872492)Franklin Sales & Mfg. Co.1987-07-22
LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER (K871206)Phase-R Corp.1987-07-22
EASY EYES TM LENS CARRYING CASE (K871741)Eaton Medical Corp.1987-07-22
DENTAL FACE MASKS, POLYESTER (K871558)Carl Parker Associates, Inc.1987-07-22
AMBULATORY EEG PLAYBACK (K872183)Cadwell Laboratories, Inc.1987-07-21
SERIES 2000 BEDSIDE PATIENT MONITOR (K872354)Marquette Electronics, Inc.1987-07-21
AN3100 MULHOLLAND DRAIN (K872459)H.W. Andersen Products, Inc.1987-07-21
MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM (K871585)Depuy, Inc.1987-07-21
VITALLIUM WIRE (K872746)Austenal Dental, Inc.1987-07-21
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET (K872349)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR PHENYTOIN CALIBRATOR SET (K872142)Innotron of Oregon, Inc.1987-07-21
IMPERVA-A (K871899)Shofu Dental Corp.1987-07-21
EYE GARD (K872000)Treace Medical, Inc.1987-07-21
QM300 HAPTOGLOBIN ANTIBODY PACK (K872717)Kallestad Diag, A Div. of Erbamont, Inc.1987-07-21
RGB CAMERA SYSTEM (K872661)Aspen Laboratories, Inc.1987-07-21
MOSS(R) GASTROSTOMY TUBE CAT #5-17719 (K871554)Mfg. and Research, Inc.1987-07-21
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET (K872461)Innotron of Oregon, Inc.1987-07-21
ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP (K872270)Orthoconcept, Inc.1987-07-21
MEDTENS(TM), MODEL NUMBER 7725 (K871722)Medtronic Vascular1987-07-21
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS. (K870916)Ge Medical Systems Information Technologies1987-07-21
FILM AND PAPER COMBINATION STERILIZING BAG (K871798)Cost Rite Health Products, Inc.1987-07-21
SIRECUST MODEL 960 AND 961 PATIENT MONITORING (K872249)Medical Electronics Laboratories, Inc.1987-07-21
DIDECO-SHILEY BLOOD REINFUSION BAG (K872162)Shiley, Inc.1987-07-21
TRAKEFIT TRACHEOSTOMY TUBE HOLDER (K872277)Ackrad Laboratories1987-07-21
MODIFIED MODEL 9431 TELETRACE TRANSMITTER (K872246)Medtronic Vascular1987-07-21
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (K872397)Roche Diagnostic Systems, Inc.1987-07-21
AN3500 WORTH DRAIN (K872457)H.W. Andersen Products, Inc.1987-07-21
ANTI-DNP MICROASSAY (K872560)Diamedix Corp.1987-07-21
1.1 COUPLERS AND 1.2 ADAPTERS (K872550)Micro-Aire Surgical Instruments, Inc.1987-07-21
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET (K872462)Innotron of Oregon, Inc.1987-07-21
HILARIS-NORI ENDOMETRIAL APPLICATOR (K871216)Mick Radio-Nuclear Instruments, Inc.1987-07-21
NOMAD (BASE UNIT/PORTABLE UNIT) (K872449)Minnesota Valley Engineering, Inc.1987-07-21
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH (K872627)Serono Diagnostics, Inc.1987-07-21
SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 (K861374)Kontron Instruments, Inc.1987-07-21
CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS (K872511)Catachem, Inc.1987-07-21
TWO FLUID W/CHECK VALVE (K871843)Panamedix, Inc.1987-07-21
SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (K871511)Medical Energy, Inc.1987-07-21
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (K871972)American Dade1987-07-21
DIDECO-SHILEY WASTE COLLECTION BAG (K872158)Shiley, Inc.1987-07-21
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET (K872463)Innotron of Oregon, Inc.1987-07-21
ETHANOL CALIBRATOR (K872181)American Monitor Corp.1987-07-21
SERVO VENTILATOR 900 C/D (K871354)Siemens Elema AB1987-07-21
VINYL POLYSILOXANE IMPRESSION SYSTEM (K872745)Crown Delta Corp.1987-07-21
BI-ARTICULAR II HIP DEVICE (K872019)Zimmer, Inc.1987-07-21
COMPANION 50 REGULATOR/FLOWMETER (K872443)Puritan Bennett Corp.1987-07-21
WASHING/INJECTION NEEDLE (K872060)Endovations1987-07-21
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY (K872286)Ciba Corning Diagnostics Corp.1987-07-21
HSC UNIT ROD (K871870)Research Development Corp.1987-07-21
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (K872714)Roseburg SA1987-07-21
KANGLE CONDOM (K871020)Lindley Company, Inc.1987-07-21
MODIFIED NOFLO I (K871262)Design Technologies, Inc.1987-07-21
IMPERVA-P (K871898)Shofu Dental Corp.1987-07-21
CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM (K872156)Concept, Inc.1987-07-21
CORD-ASSURE UMBILICAL BLOOD GAS KIT (K872244)Lake Medical Products, Inc.1987-07-21
INNOFLUOR VANCOMYCIN CALIBRATOR SET (K872644)Innotron of Oregon, Inc.1987-07-21
TEMREX ETCHING GEL (K872569)Scientific Pharmaceuticals, Inc.1987-07-21
TDXR FETAL LUNG MATURITY (K871593)Abbott Laboratories1987-07-20
ENZYGNOST ANTI-CMV IGG TEST (K863488)Behring Diagnostics, Inc.1987-07-20
CLEARFIL CORE NEW BOND (K871637)Kuraray Co.1987-07-17
FLEXIBLE FASCICULATED BONE PLATE (K870041)The Deca Co.1987-07-17
CLEARFIL FII NEW BOND (K871634)Kuraray Co.1987-07-17
ALTERNARIA TENUIS ALLERGEN DISC (K871684)Incstar Corp.1987-07-16
CARBON ELECTRODE (K872044)Futuremed Div. of Future Impex Corp.1987-07-16
DYNATECH SPD 3000, #002-900-0000 (K872363)Dynatech Laboratories, Inc.1987-07-16
V-MARC 88A COMPUTER (K871853)V.Marc, A Div. of Pictorial, Inc.1987-07-16
RESPIRONICS SANDERS BIPAPEASY (K871523)Respironics, Inc.1987-07-16
VAS-CATH PERITONEAL DIALYSIS CATHETER (K871817)Vas-Cath of Canada , Ltd.1987-07-16
HEARING AID 49 SERIES (K872554)Electone, Inc.1987-07-16
HEARING AID S45 SERIES (K872553)Electone, Inc.1987-07-16
HEARING AID M35/M36 SERIES (K872556)Electone, Inc.1987-07-16
CHOLESTEROL REAGENT (K872295)Sigma Diagnostics, Inc.1987-07-16
1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS (K872491)Micro-Aire Surgical Instruments, Inc.1987-07-16
NITROGLYCERINE PUMP SET (K871084)Churchill Corp.1987-07-16
UROVIEW (K872022)Oec-Diasonics, Inc.1987-07-16
CLEARFIL POSTERIOR 3 (K871635)Kuraray Co.1987-07-16
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. (K871220)Cooper Lasersonics, Inc.1987-07-16
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (K872582)Millipore Corp.1987-07-16
HENSCHKE AFTERLOADING APPLICATOR (K871217)Mick Radio-Nuclear Instruments, Inc.1987-07-16
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505 (K871137)Dlp, Inc.1987-07-16
NEUROCOM PRESSURE TEST SYSTEM (K871652)Neurocom International, Inc.1987-07-16
DELFLEX RIGID DRAIN CONTAINER (K871155)Delmed, Inc.1987-07-16
KUMAR CERVICAL APPLICATOR (K871213)Mick Radio-Nuclear Instruments, Inc.1987-07-16
ROKONICS 8500 (K871576)Rokonics, Inc.1987-07-16
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (K870176)Genetic Systems Corp.1987-07-16
MINOS AUTOMATIC CELL COUNTER (K864579)Abx, Inc.1987-07-16
PORTABLE DENTAL X-RAY UNIT MODEL 4000 (K872240)Home/Office Dental, Inc.1987-07-16
NICOLET AMP 6R11 SYSTEM (K871678)Nicolet Biomedical Instruments1987-07-16
LEAD GLASS SHIELDS (K872656)Viox Corp.1987-07-16
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES (K872130)Syva Co.1987-07-16
SPERM WASHING MEDIUM #9932 (K872102)Irvine Scientific1987-07-16
HDL CHOLESTEROL REAGENT (K872575)Sigma Chemical Co.1987-07-16
STANDARD SCREW DRIVER (K872387)Med-Tool, Inc.1987-07-16
VICE OR BENCH VICE (K872385)Med-Tool, Inc.1987-07-16
MURRAY/WELCH TOTAL HIP SYSTEM (K871402)Kirschner Medical Corp.1987-07-16
CURETTE SET, ANTRUM, COAKLEY (K872609)Military Engineering, Inc.1987-07-15
HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES (K871577)Irvine Scientific1987-07-15
TRANSWORLD 360V, MODEL A1-4040 (K872357)Transworld X-Ray Corp.1987-07-15
PRECISION SCREW DRIVER SET (K872389)Med-Tool, Inc.1987-07-15
CONDUCTIVITY GEL (K872045)Futuremed Div. of Future Impex Corp.1987-07-15
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Every clearance here is in the API, with alerts when new ones post.