Atlas FDA

1990

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

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RecordFirmDate
SCHOLTEN FRAME (K900405)Scholten Surgical Instruments, Inc.1990-03-01
ABBOTT COMMANDER PARALLEL PROCESSING CENTER (K897158)Abbott Laboratories1990-03-01
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. (K900656)Labeltape Meditect, Inc.1990-03-01
LYTENING 2Z LYTENING SYSTEM 31 (K900300)Baxter Healthcare Corp1990-03-01
REPEL SURGICAL GLOVE LINERS (K900310)Depuy-Raynham1990-03-01
CENTERING PLUG (K900392)Allo Pro Corp.1990-03-01
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781 (K900250)American Research Products Co.1990-03-01
MODIFIED DSL-2300 ACTH RIA (K900147)Diagnostic Systems Laboratories, Inc.1990-03-01
BICARBONATE REAGENTS PRODUCT #7713 & #7714 (K900420)American Research Products Co.1990-03-01
SPECIMEN CONTAINER (K896794)Westmark, Sterile Packing Systems, Inc. (Sps)1990-03-01
DISCO SUNGLASSES (NON-PRESCRIPTION) (K900387)Le-I Electronic Co. , Ltd.1990-02-28
TYPE 9291 INTERFACE RESPIRATOR (K896736)S & W Medico Teknik1990-02-28
IV TRIFURCATED EXTENSION SET (K900427)Marquette Medical, Inc.1990-02-28
KING OF HEARTS 1200 MONITOR (K896039)Instromedix, Inc.1990-02-28
AIV SYSTEMS' IV POLES (K895776)Automated IV Systems, Inc.1990-02-28
CATHETER BALLOON DILATOR PRESSURE GAUGE (K895511)Argon Medical Corp.1990-02-28
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (K894826)Bentley Laboratories, Inc.1990-02-28
COMFEES(R) + CON-PAK(TM) LENS CASE (K897085)Magnivision, Inc.1990-02-28
TYPE 9292 INTERFACE CAPNOGRAPH (K896737)S & W Medico Teknik1990-02-28
INSITUCAT VALVE STRIPPER (K885046)Aesculap Instruments Corp.1990-02-28
ACCESSOR PERIPHERAL DILATING GUIDE WIRE (K895179)Peripheral Systems Group1990-02-28
NEEDLE-SHIELD (K900282)Macbrud Corp. Medical Div.1990-02-28
PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV (K890182)Aesculap Instruments Corp.1990-02-28
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR (K893711)Shiley, Inc.1990-02-28
TYPE 9290 INTERFACE RESPIRATOR (K896735)S & W Medico Teknik1990-02-28
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH. (K896741)Schneider Intl., Ltd.1990-02-28
CONFEES(R)+ CONTACT LENS HOLDER (K897084)Magnivision, Inc.1990-02-28
ACS INDEFLATOR XX (K896849)Advanced Cardiovascular Systems, Inc.1990-02-28
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE (K896978)Medtronic Vascular1990-02-28
MODEL 8500 HAND HELD PULSE OXIMETER (K893221)Nonin Medical, Inc.1990-02-28
IV BIFURCATED EXTENSION SET (K900426)Marquette Medical, Inc.1990-02-28
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 (K900422)Helena Laboratories1990-02-27
CATHETER ADAPTER SEALING CAP NO. 48-1028-9 (K900006)National Medical Care, Medical Products Div., Inc.1990-02-27
RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE (K896777)Research Medical, Inc.1990-02-27
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM (K897110)Medisense, Inc.1990-02-27
MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER* (K900129)United States Surgical, A Division of Tyco Healthc1990-02-27
CRYOTRON-UL30 (K900419)Henley Intl.1990-02-27
MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP. (K900523)J & B Assoc.1990-02-27
DIRECT BILIRUBIN REAGENT (K900259)Medical Analysis Systems, Inc.1990-02-27
MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE (K900525)J & B Assoc.1990-02-27
LATEX SURGICAL GLOVES (K890019)Argos S.A.1990-02-27
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3 (K900004)National Medical Care, Medical Products Div., Inc.1990-02-27
KEY VASCULAR LOOPS (K896676)Key Surgical, Inc.1990-02-27
INFRAVIB MASSAGER - MODEL PR-1000 (K900384)Infralux International, Inc.1990-02-27
OPTIKEM PMMA CONTACT LENS (K895411)Optikem Polymers, Inc.1990-02-27
CONVERTER SYSTEM (K894248)Mira, Inc.1990-02-27
CMV IGM ELISA TEST SYSTEM (K896355)Zeus Scientific, Inc.1990-02-27
COBAS READY ALBUMIN REAGENT (K896235)Roche Diagnostic Systems, Inc.1990-02-27
COBAS READY TOTAL BILIRUBIN REAGENT (K896232)Roche Diagnostic Systems, Inc.1990-02-27
JYROCHAIR POWER WHEELCHAIR (K900514)Jyrochair, Inc.1990-02-27
RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE (K896778)Research Medical, Inc.1990-02-27
COBAS READY BUN REAGENT (K896236)Roche Diagnostic Systems, Inc.1990-02-27
QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3 (K896956)National Medical Care, Medical Products Div., Inc.1990-02-27
AUTOREADER CALIBRATION TEST PLATE (K900579)Bio-Tek Instruments, Inc.1990-02-27
TECNOL LAZER(TM) SURGICAL MASK (K896193)Tecnol New Jersey Wound Care, Inc.1990-02-27
POSITIVE AND NEGATIVE HCG SERUM CONTROLS (K896875)Armkel, LLC1990-02-26
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) (K895379)Physio-Control Corp.1990-02-26
1400 SERIES EVIDENCE COLLECTION KIT (K896373)Transidyne General Corp.1990-02-26
TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1 (K896761)National Medical Care, Medical Products Div., Inc.1990-02-26
3M IV FLOW REGULATOR (K896907)3M Company1990-02-26
DU PONT MAMMOGRAPHY CASSETTE (K900620)E.I. Dupont DE Nemours & Co., Inc.1990-02-26
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY (K896097)Vitek Systems, Inc.1990-02-26
PFM-90 CEILING TUBE SUPPORT (K900234)Fischer Imaging Corp.1990-02-26
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 (K900251)Helena Laboratories1990-02-26
DUAL GUIDE INTRODUCER CATHETER (K895044)Cook, Inc.1990-02-26
HOFMANN-NAGEL (HOFNA) X-RAY TUBES (K900367)Hofmann1990-02-26
AIA-PACK BMG (K900440)Tosoh Medics, Inc.1990-02-26
SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM (K896951)Medisense, Inc.1990-02-26
BIODEX BACK SYSTEM ATTACHMENT (K900741)Biodex Corp.1990-02-26
4 SURE EXTERNAL MALE CATHETER (K896726)The Boston & Pacific Co., Inc.1990-02-26
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET (K900625)Armkel, LLC1990-02-26
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1 (K896763)National Medical Care, Medical Products Div., Inc.1990-02-26
SMALL CATHETER INFLATOR (K896005)Allied Systems Co.1990-02-26
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (K897150)Toyo Jozo Co., Ltd.1990-02-26
CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO. (K897026)Canyon Medical Products1990-02-26
NOBLES-LAI ENGINEERING INFUSION PUMP (K895688)Nobles-Lai Engineering, Inc.1990-02-26
EKG, ECG KENZ, ECG 302 (K896771)Cambridge Medical Instruments, Inc.1990-02-26
TCT-300S - UPGRADE (K900233)Toshiba America Medical Systems, In.C1990-02-26
UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5 (K896764)National Medical Care, Medical Products Div., Inc.1990-02-26
AXIAL AND OFFSET CROSSLINK PLATES (K896740)Danek Medical, Inc.1990-02-26
CATHETER PLUG/PROTECTOR (K896806)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-26
EKG, ECG KENZ, ECG 303 (K896772)Cambridge Medical Instruments, Inc.1990-02-26
DISPOSABLE RESPIRTORY KIT (MP-200) (K896885)Medipart Jerry Alexander1990-02-26
TBD IONTOPHORESIS ELECTRODE (K896703)Empi1990-02-26
SXT-60F/60M MOBILE C ARM X-RAY UNIT (K896387)Toshiba America Medical Systems, In.C1990-02-23
MODEL BT-1 FOT BOLT INSTALLATION KIT (K896834)Pearl Instruments Corp.1990-02-23
ALPHA-STIM CS (K896948)Electromedical Products, Inc.1990-02-23
COULTER AST (GOT) REAGENT (K897165)Coulter Electronics, Inc.1990-02-23
THYROID STIMULATING HORMONE-EIA-XT (K896867)In Vitro Diagnostics, Inc.1990-02-23
QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (K894992)Quantum Medical Systems, Inc.1990-02-23
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC (K896744)Bio-Rad1990-02-23
BIOTRACK IMMUNOCHEMISTRY MONITOR (K900372)Biotrack, Inc.1990-02-23
SERATEST ENA [SSA] KIT (K900617)Hemagen Diagnostics, Inc.1990-02-23
COULTER TOTAL PROTEIN REAGENT (K897166)Coulter Electronics, Inc.1990-02-23
SIEMENS ENDO-P-PROBE (K897098)Siemens Medical Solutions USA, Inc.1990-02-23
HYPEX (K895274)Global Business, Inc.1990-02-23
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM (K900498)Cardiac Pacemakers, Inc.1990-02-23
QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM (K895147)Quantum Intl.1990-02-23
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (K897169)Photec Diagnostics, Inc.1990-02-23
MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE (K900586)Medrad, Inc.1990-02-23
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