Atlas FDA

1989

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

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RecordFirmDate
CLOSED SYSTEM URINARY DRAINAGE BAG (K890465)Cypress Medical Products, Ltd.1989-05-23
WILLIAMS BELT & BOOT (K891387)Arthro-Medic, Inc.1989-05-23
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS (K891601)Mira, Inc.1989-05-23
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER (K891290)Cook Ob/Gyn1989-05-23
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT (K890618)Kenlor Industries, Inc.1989-05-22
ARGEDENT 45 (K892814)Argen Precious Metals, Inc.1989-05-22
PATIENT EXAMINATION GLOVES (LATEX) (K892103)Jenq Chuam Industrial Co., Ltd.1989-05-22
ARGELITE 80SF+ DENTAL ALLOY (K892909)Argen Precious Metals, Inc.1989-05-22
ROCHE(R) CARDIOSCREEN-CK (K891462)Roche Diagnostic Systems, Inc.1989-05-22
AUTOTRANSFUSION DEVICE (K892819)Impra, Inc.1989-05-22
NON-STERILE PATIENT EXAMINATION GLOVES (LATEX) (K892747)Asia Way Trading, Inc.1989-05-22
DUPONT DISTAL HUMERAL NAIL (K890939)Howmedica Corp.1989-05-22
PATIENT EXAMINATION GLOVES (LATEX)(POWDERED) (K891640)Perusahaan Getah Asas Sdn. Bhd.1989-05-22
MULTI PULSE POWER UNIT GENERATOR (K892943)GE Medical Systems1989-05-22
AVL MODEL 987 ELECTROLYTE ANALYZER (K891578)Avl Scientific Corp.1989-05-22
PATIENT EXAMINATION GLOVE (K890592)Alfaseal Sdn. Bhd.1989-05-22
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891468)Trace Scientific , Ltd.1989-05-22
ESP RADIATION REDUCTION EXAMINATION GLOVES (K891968)Boston Scientific Corp1989-05-22
OXITRON OXYGEN ANALYZER (K890958)Oxitron Medical Products1989-05-22
COAG-1 APTT TEST CARD (K891015)Cardiovascular Diagnostic Services1989-05-22
AMNIO-GROW TM (K892938)Inovar Biologicals, Inc.1989-05-22
ACA VANCOMYCIN (VANC) METHOD (K892900)E.I. Dupont DE Nemours & Co., Inc.1989-05-22
PATIENT EXAMINATION GLOVES (LATEX) (K891177)Garrett-Hewitt Intl., Inc.1989-05-22
DRI-DYE CHECK STRIPS (TM)-405 (K892656)Awareness Technology, Inc.1989-05-22
PATIENT EXAMINATION GLOVES (LATEX) (K891638)Tak Ent., Inc.1989-05-22
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER (K891480)Yellow Springs Instrument Co., Inc.1989-05-22
ND1100 BONE DENSITY SCANNER (K881383)Nuclear Data, Inc.1989-05-22
T4 CLASP-BEAD EIA KIT (K892853)Biotecx Laboratories, Inc.1989-05-22
PATIENT EXAMINATION GLOVES (LATEX) (K892093)Wah Chiang Ent. Sdn Bhd1989-05-22
ARGELITE 60 (K892813)Argen Precious Metals, Inc.1989-05-19
KENDALL CURITY FEEDING TUBES (K892431)The Kendal Co.1989-05-19
ARGIPAL (K893011)Argen Precious Metals, Inc.1989-05-19
INTRODUCER FOR PTCA GUIDING CATHETERS (K891022)Argon Medical Corp.1989-05-19
ARGELITE 54 (K893008)Argen Precious Metals, Inc.1989-05-19
INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA (K890525)Magnatone Hearing Aid Corp.1989-05-19
ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM (K891463)Confi-Dental Products Co.1989-05-19
HIGH PRESSURE CONNECTING SETS (K890208)E-Z-Em, Inc.1989-05-19
ARGEDENT 45SF (K892815)Argen Precious Metals, Inc.1989-05-19
THE COACH (K884804)Promark, Inc.1989-05-19
KENDALL SCD THERAPEUTIC SYSTEM (K890938)Kendall Healthcare Products Co. Div.Of Tyco Health1989-05-19
E-Z-FLOW ANGIOGRAPHY CATHETERS (K890206)E-Z-Em, Inc.1989-05-19
PERSONAL ALERT ASSIST DEVICE (K890445)Silent Call Corp.1989-05-19
DISPOSABLE ANGIOGRAPHY NEEDLES (K890209)E-Z-Em, Inc.1989-05-19
ARGELITE SR+ (K893009)Argen Precious Metals, Inc.1989-05-19
ARGELITE 75+6 (K892812)Argen Precious Metals, Inc.1989-05-19
REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID (K892333)Rexton, Inc.1989-05-19
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC (K892336)Qualitone1989-05-19
ARGELITE 58P (DENTAL ALLOY) (K891320)Argen Precious Metals, Inc.1989-05-19
MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. (K891230)Medtronic Blood Systems, Inc.1989-05-19
HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS (K892211)Heraeus Lasersonics, Inc.1989-05-19
ARGELITE 80SF DENTAL ALLOY (K892908)Argen Precious Metals, Inc.1989-05-19
ARGEDENT Y-86 DENTAL ALLOY (K892708)Argen Precious Metals, Inc.1989-05-19
MODIFIED EXTERNAL PAD (K891000)Instromedix, Inc.1989-05-19
FORTEC MI-150 DIGITAL BLOOD PRESSURE METER (K884405)Nam Tai Electronic & Electrical Products, Ltd.1989-05-19
ARGEDENT 38 (K892816)Argen Precious Metals, Inc.1989-05-19
MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR (K890274)Nihon Kohden America, Inc.1989-05-18
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD (K892872)National Medical Care, Medical Products Div., Inc.1989-05-18
RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4 (K891464)Confi-Dental Products Co.1989-05-18
SCOPIX LASER IMAGER (K891924)Enhanced Imaging Technologies, Inc.1989-05-18
ARGEDENT 75 (K892234)Argen Precious Metals, Inc.1989-05-18
DENTAL HAND INSTRUMENTS (K892239)Implant Support Systems, Inc.1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD (K892870)National Medical Care, Medical Products Div., Inc.1989-05-18
QCT-LUNG NODULE (TM) ANALYSIS PACKAGE (K891931)Image Analysis, Inc.1989-05-18
PULMONARY RESUSCITATOR, MODIFICATION (K892221)Life Design Systems, Inc.1989-05-18
DENTIN PRIMER (K891455)Dentsply Intl.1989-05-18
SUCTION TUBES: HOUSE, BARON (K892549)Zinnanti Surgical Instruments, Inc.1989-05-18
MODIFIED AM-SERIES DIALYZERS (K892375)Asahi Medical Co., Ltd.1989-05-18
MODIFIED THER-A-PULSE UNIT (K884396)Westec Corp.1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD (K892871)National Medical Care, Medical Products Div., Inc.1989-05-18
SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM (K884732)Bio-Interfaces, Inc.1989-05-18
INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION) (K891176)Multi-Med, Inc.1989-05-18
Q5000 PC WORKSTATION (K892113)Quinton, Inc.1989-05-18
NEW AM-SERIES DIALYZERS (K892374)Asahi Medical Co., Ltd.1989-05-18
SGARLATO LESSER TOE IMPLANT (K884739)Sgarlato Laboratories, Inc.1989-05-18
WOODLYN OPHTHALMIC PROJECTOR (K890992)Woodlyn, Inc.1989-05-17
SITE PERISTALTIC CASSETTE (K892911)Site Microsurgical Systems, Inc.1989-05-17
NOVA GEL(TM) JO-1 (K892897)Inova Diagnostics, Inc.1989-05-17
MCDONALD FOLDING FORCEPS (K885230)Alcon Laboratories1989-05-17
FETAL HEMOGLOBIN (K892241)Sure-Tech Diagnostic Associates, Inc.1989-05-17
LACRIMAL EFFICIENCY TEST (TM) (K890714)Lacrimedics, Inc.1989-05-17
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER (K890055)Acuson Corp.1989-05-16
MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (K884151)Miele Appliances, Inc.1989-05-16
INTRAVASCULAR ADMINISTRATION SET MODEL 60040 (K891009)3M Company1989-05-16
KITCHIN DENTAL ABCESS DRAIN (K885231)Kitchin, Inc.1989-05-16
CVIS ULTRA-SCAN ONE IMAGING SYSTEM (K891386)Cardiovascular Imaging Systems, Inc.1989-05-16
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (K890919)Eagle Vision, Inc.1989-05-16
GENTLE EXPRESSIONS ELECTRIC BREAST PUMP (K890588)Healthteam1989-05-16
THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION (K890407)Circle Rubber Corp.1989-05-16
GRIESHABER VISCOELASTIC INJECTION SYSTEM (K890783)Grieshaber & Co.1989-05-16
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER (K891309)Advanced Technology Laboratories, Inc.1989-05-16
DRI-VENT ARTERIAL BLOOD SAMPLING KIT (K883840)Concord Laboratories, Inc.1989-05-16
TDX BARBITURATES SERUM (K892650)Abbott Laboratories1989-05-16
TRANSESOPHAGEAL TRANSDUCER PEF-511SA (K890969)Toshiba Medical Systems1989-05-16
PH BLOOD GAS CONTROL PRODUCTS (K884266)Alko Diagnostic Corp.1989-05-16
GDS ENZYMATIC THEOPHYLLINE REAGENT (K891761)Gds Diagnostics1989-05-16
AML(R) COLLARLESS LATERALIZED FEMORAL HIP (K891482)Depuy, Inc.1989-05-16
ACA VANCOMYCIN CALIBRATOR (K892901)E.I. Dupont DE Nemours & Co., Inc.1989-05-16
ELECTROSURGICAL PENCIL (K892502)Yuntek International, Inc.1989-05-15
A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL (K885348)Mallinckroot, Inc.1989-05-15
ACCU-BEAM YAG FIBER (K890922)Tti Medical1989-05-15
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Every clearance here is in the API, with alerts when new ones post.