Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PORTA'PURE/DENTAL (K961409)Water Solution Technologies1996-06-12
ELECSYS T-UPTAKE ASSAY (K961488)Boehringer Mannheim Corp.1996-06-12
QUANTASE PHENYLALANINE ASSAY (K961515)Shield Diagnostics, Ltd.1996-06-12
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP (K961325)Princeton BioMeditech Corp.1996-06-12
AVL 9180 ELECTROLYTE ANALYZER (K961458)Avl Scientific Corp.1996-06-12
CLINITEK 50 URINE CHEMISTRY ANALYZER (K960546)Bayer Corp.1996-06-12
ELECSYS HCG ASSAY (K961487)Boehringer Mannheim Corp.1996-06-12
SPINAL TOUCH (K961212)Fasstech1996-06-12
ESI-5000 (K935024)Elscint, Inc.1996-06-12
TRICYCLICS SERUM TOX ASSAY (K961393)Diagnostic Reagents, Inc.1996-06-12
UPACS VERSION 1.7 (K961160)Base Ten Systems, Inc.1996-06-11
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) (K961828)Bio-Rad1996-06-11
BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC (K961040)Dayspring Medical, Inc.1996-06-11
ELECSYS CK-MB (K961501)Boehringer Mannheim Corp.1996-06-11
TYMPANOSTOMY VENTILATION TUBE (K961945)Advanced Microbotics Corp.1996-06-11
ELECSYS TROPONIN T (K961500)Boehringer Mannheim Corp.1996-06-11
AQ HYDROPHILIC UROLOGICAL CATHETERS (K962004)Cook Urological, Inc.1996-06-11
ESOPHAGEAL MANOMETRY ANALYSIS MODULE (K961070)Synectics Medical, Inc.1996-06-11
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER (K955104)Automatic Liquid Packaging, Inc.1996-06-11
WET-PREP (K961822)Bisco, Inc.1996-06-11
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 (K961301)Delphi Consulting Group1996-06-11
ELECSYS FT4 ASSAY (K961489)Boehringer Mannheim Corp.1996-06-11
OSTAR EXAMINATION GLOVES (K955947)Contract Latex Dippers Sdn Bhd1996-06-10
JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY (K961227)J.J. Skinner, Inc.1996-06-10
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM (K955389)Siemens Medical Solutions USA, Inc.1996-06-10
OSTAR (K955424)Ultravena Industries, Ltd.1996-06-10
TONGUE SCRAPPER (K961574)U.S. Dentek Corp.1996-06-10
LESE STENTS SETS (K952513)Cook Urological, Inc.1996-06-10
BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL (K961026)Dayspring Medical, Inc.1996-06-10
ELECTRONIC THERMOMETER (K961879)Wiltec Industries , Ltd.1996-06-10
ASEPTYLUM, UNI-CARRIER (K961714)Distriflor S.A.1996-06-10
CRYTRON SYSTEM (K955529)Mark H. Friedman1996-06-10
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION (K936135)Sudormed, Inc.1996-06-10
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE (K955634)Boston Medical Products, Inc.1996-06-10
POS-T-VAC ID-300 (K961309)Pos-T-Vac, Inc.1996-06-10
CLS STEM (MODIFICATION) (K953690)Intermedics Orthopedics1996-06-07
ASPIRATION/IRRIGATION CATHETER (K961300)Neuro Navigational Corp.1996-06-07
FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS (K961623)Becton Dickinson Monoclonal Center1996-06-07
LMD CRYPTOSPORIDIUM ANTIGEN DETECTION (K955345)Lmd Laboratories1996-06-07
SHIELDED TROCAR (OBTURATOR) (K954774)Gabris Surgical Corp.1996-06-07
MEDI-TRACE RADIOLUCENT (K961395)Graphic Controls Corp.1996-06-07
OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER (K955059)Siemens Medical Solutions USA, Inc.1996-06-07
HEARTPORT ENDOAORTIC CLAMP (K955132)Heartport, Inc.1996-06-07
PROTEK LOW PROFILE ACETABULAR CUP (K960025)Intermedics Orthopedics1996-06-07
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960) (K952054)Siemens Medical Solutions USA, Inc.1996-06-07
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (K960981)Kodak Health Imaging Systems, Inc.1996-06-07
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) (K960183)Smithkline Diagnostics, Inc.1996-06-07
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM (K951709)Mardx Diagnostics, Inc.1996-06-07
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951821)Light Diagnostics1996-06-07
1.2MM REUSABLE NEUROVIEW ENDOSCOPE (K961173)Neuro Navigational Corp.1996-06-07
FIRARD II/ TDP LAMP (K960036)Helio Medical Supplies, Inc.1996-06-06
CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE) (K961061)Codi International BV1996-06-06
NON-PRESCRIPTION SUNGLASSES (K961990)Rokko Stars Co., Ltd.1996-06-06
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS (K960704)Depuy, Inc.1996-06-06
UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) (K961051)Kinetikos Medical, Inc.1996-06-06
BAXTER SODIUM ACETATE INFANT HEEL WARMER (K961154)Baxter Healthcare Corp1996-06-06
MX703 AND MX730 CONTINUOUS FLUSH DEVICES (K961527)Medex, Inc.1996-06-06
BIOVIEW MODEL S960000 (K961056)Sandhill Scientific, Inc.1996-06-06
HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND (K954131)Hoveround Corp.1996-06-06
ACU-LAB (K955776)Glederer & Co., Inc.1996-06-05
MEDICOUNT DEKA HEMATOLOGY ANALYZER (K942525)Cea America Corp.1996-06-05
ACE SREW DENTLA IMPLANT SYSTEM (K954513)Ace Surgical Supply Co., Inc.1996-06-05
TINTELIZE PAI-1 KIT (K960438)Medical Diagnostic Technologies, Inc.1996-06-05
ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 (K960676)Zoll Medical Corp1996-06-05
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM (K950829)Mardx Diagnostics, Inc.1996-06-05
GLOVE SEAL & SET-RITE (K954063)Contract Latex Dippers Sdn Bhd1996-06-05
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) (K960614)Somanetics Corp.1996-06-05
IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW (K960900)Imcor1996-06-05
SUCTION SAFETY DEVICE (K960937)R D Intl.1996-06-05
STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS (K961020)Steri-Oss, Inc.1996-06-05
CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113)Clinical Neuro Systems, LLC1996-06-05
ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE (K960045)The Sewing Source, Inc.1996-06-05
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE (K955181)United States Endoscopy Group, Inc.1996-06-05
ACE CYLINDER DENTAL IMPLANT (K954605)Ace Surgical Supply Co., Inc.1996-06-05
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (K950806)Mira, Inc.1996-06-05
TAS A PTT TEST CONTROLS (K961189)Cardiovascular Diagnostics, Inc.1996-06-05
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET (K953681)Haemonetics Corp.1996-06-04
NIPRO ARTERIAL VENOUS FISTULA NEEDLE (K955182)Nissho Corp.1996-06-04
KOWA HAND-HELD APPLANATION TONOMETER HA-1 (K960924)Kowa Optimed, Inc.1996-06-04
7100 SWALLOWING WORKSTATION (K954798)Kay Elemetrics Corp.1996-06-04
LIQUICHEK RHEUMATOID FACTOR CONTROL (K960987)Bio-Rad1996-06-04
QUANTEC SERIES 2000 ENDODONTIC FILES (K962031)Tycom Dental1996-06-04
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK (K960957)Sims Deltec, Inc.1996-06-04
SAMS 8000 CARDIOPLEGIA MONITOR (K960916)3M Health Care, Sarns1996-06-04
RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (K955687)Contour Fabricators of Florida, Inc.1996-06-03
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD (K961351)Bayer Corp.1996-06-03
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (K961097)Debusk Knitting Mills, Div. Deroyal Industries1996-06-03
WHEELED STRETCHER (K961437)Hill-Rom, Inc.1996-06-03
U-DOA CONTROLS (K961724)Medical Diagnostic Technologies, Inc.1996-06-03
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM (K960086)Slt-J , Ltd.1996-06-03
PULSEMASTER (K961136)American Dental Technologies, Inc.1996-06-03
UPACS (K960941)Base Ten Systems, Inc.1996-06-03
THE COBALT SCALPEL (K960892)Nova Therapeutic System1996-06-03
SDL DIODE LASER SYSTEM (K960905)Slt-J , Ltd.1996-06-03
LACTATE DEHYDROGENASE REAGENT SET (K961431)Pointe Scientific, Inc.,1996-06-03
3030 INFUSION PUMP (K955258)Sabratek Corp.1996-06-03
FOREFOOT RECONSTRUCTION SYSTEM (K961485)Howmedica Corp.1996-06-01
SPACELABS MEDICAL MULTIGAS ANALYZER (K954962)Spacelabs, Inc.1996-05-31
SUNGLASSES (K961146)Erica Optical Co.1996-05-31
TONGUE CLEANER (K961660)Jack Conrey1996-05-31
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Every clearance here is in the API, with alerts when new ones post.