Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
INTRASCAN II (K944771)Markcare Medical Systems, Inc.1995-01-26
BERNSTEIN(TM) UTERINE MANIPULATOR (K932394)Gm Engineering, Inc.1995-01-26
BRIMFIELD PRECISION GRASPER/DISSECTOR (K946263)Springfield Surgical Instruments1995-01-26
TOHP-CAP (K941031)Jrm Ent., Inc.1995-01-26
CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE (K946307)Confi-Dental Products Co.1995-01-26
IMAGYN MICROLAP INTRODUCER (K943810)Imagyn Medical, Inc.1995-01-26
ORAL STEEL CARTRIDGE SYRINGE (K941915)Robert W. Bauer & Assoc., Inc.1995-01-26
VIDEO ENDOSCOPE SYSTEM WITH ZOOM (K946171)Oktas1995-01-26
ULTRASAFE ASPIRATING SYRINGE (K944425)Safety Syringes, Inc.1995-01-26
PULPDENT PERIODONTAL DRESSINGS (K946137)Pulpdent Corp.1995-01-26
TRU-TOUCH MEDICAL GLOVES (K944183)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-01-26
LINK SADDLE PROTHESIS (K943277)Turnkey Intergration USA, Inc.1995-01-26
OPTUS SINUSCOPES AND ACCESSORIES (K944656)Optus, Inc.1995-01-26
BOTTLE COLLECTION SET (K945179)Medgyn Products, Inc.1995-01-26
I.V.I.D. FLUID ADMINISTRATION SET MARKER (K944619)Advanced Bioresearch Assoc.1995-01-26
PHONAK SONO-FORTE 332X-AZ (K946294)Phonak, Inc.1995-01-26
ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION (K941622)Siemens Medical Solutions USA, Inc.1995-01-26
UNITRON MODEL SOUNG F/S (K946264)Unitron Industries, Inc.1995-01-26
MRT-150A, MRT-150A SOFTWARE VERSION 11.9 (K941864)Toshiba America Mri, Inc.1995-01-26
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES (K945788)KARL STORZ Endoscopy-America, Inc.1995-01-25
MODEL 405GE-64: PHASED ARRAY TMJ COIL (K944773)Medical Advances, Inc.1995-01-25
IL TEST GENTAMICIN CALIBRATORS (K943982)Instrumentation Laboratory CO1995-01-25
UTERINE MANIPULATOR/INJECTOR WITH SPRING (K941458)Zinnanti Surgical Instruments, Inc.1995-01-25
IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 (K942687)Instrumentation Laboratory CO1995-01-25
ANATOM 2000 (K944131)Analogic Corp.1995-01-25
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) (K945692)Dako Corp.1995-01-25
MODEL 792 CONVERGE, MODEL 793 VISION 2000 (K945431)Hausted, Inc.1995-01-25
FLEXART QD BODY COIL (K944662)Toshiba America Mri, Inc.1995-01-25
MICROLINE SCREEN FOR BENZODIAZEPINE (K945829)Drug Screening Systems, Inc.1995-01-25
GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER (K933818)C.G.H. Medical, Inc.1995-01-25
GENERAL PURPOSE FLEX COIL (K944469)Philips Medical Systems (Cleveland), Inc.1995-01-25
TOMTEC ECHO-VIEW (K934139)Tomtec Tomographic Technologies GmbH1995-01-25
MODEL 578 MOBILE SURGICAL STRETCHER (K943969)Hausted, Inc.1995-01-25
MODEL 528GE SERIES (K944331)Medical Advances, Inc.1995-01-25
ABUSCREEN ONTRAK POSITIVE CONTROL (K943999)Roche Diagnostic Systems, Inc.1995-01-25
ABUSCREEN ONLINE(R) CALIBRATORS (K946000)Roche Diagnostic Systems, Inc.1995-01-25
DYONICS FIXATION SCREWS (K945182)Smith & Nephew Dyonics, Inc.1995-01-24
UTERINE INJECTOR WITH SPRING (K941457)Zinnanti Surgical Instruments, Inc.1995-01-24
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID (K943835)Orion Life Systems, Inc.1995-01-24
YASARGIL, CASPAR, VARIO CLIP APPLIERS (K940970)Aesculap, Inc.1995-01-24
WILSON COOK MULTIPLE BAND LIGATOR (K944220)Wilson-Cook Medical, Inc.1995-01-24
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE (K931442)KARL STORZ Endoscopy-America, Inc.1995-01-24
THE KARL STORZ HAMOU ENDOMAT (K936231)Karl Storz Endoscopy1995-01-24
DUTEX GAUZE BANDAGE (K946326)Dumex Medical Surgical Products, Ltd.1995-01-24
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION (K946146)Clinical Controls, Inc.1995-01-24
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES (K944793)KARL STORZ Endoscopy-America, Inc.1995-01-24
STERIL-DERM-PLUS TRANSPARENT DRESSING (K931766)Biointerface Technologies, Inc.1995-01-24
KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE (K945100)KARL STORZ Endoscopy-America, Inc.1995-01-24
SURGILENE(R) SUTURES (K945701)Davis & Geck, Inc.1995-01-24
COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE (K940145)Huestis Machine Corp.1995-01-24
BALLOON DILATION CATHETER (K935094)Wilson-Cook Medical, Inc.1995-01-24
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL (K946145)Clinical Controls, Inc.1995-01-24
VARELISA M2 ANTIBODIES (K945607)Elias U.S.A., Inc.1995-01-24
STRYKER POWERED STRETCHER (K942948)Stryker Corp.1995-01-24
PROTEIN C REAGENT, COAGULOMETRIC (K924425)Behring Diagnostics, Inc.1995-01-24
3M MODEL 8233 HEARING INSTRUMENT (K943854)3M Company1995-01-24
K-DEFIB/PACE PEDIATRIC ELECTRODE (K934692)Katecho, Inc.1995-01-24
ARTHROSCOPE (K944842)5 Star Medical, Inc.1995-01-24
WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) (K942790)Cincinnati Sub-Zero Products, Inc.1995-01-24
3M(TM) SURGICAL SLIPPER, 9660 SERIES (K946162)Wahl Clipper Corp.1995-01-24
CYBERRX MODEL 7200 (K934434)Cybermed Control Systems, Inc.1995-01-24
CIT GRASPING AND DISSECTING FORCEPS (K944269)Chirurgische Instrumente1995-01-24
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) (K945576)Meadox Medicals, Div. Boston Scientific Corp.1995-01-24
WARM AIR WARMING UNIT (K942599)Cincinnati Sub-Zero Products, Inc.1995-01-24
MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES (K941207)New Eder Corp.1995-01-24
DATEMINDER CONTACT LENS CASE (K945259)Bruce A. Berkley1995-01-24
DIGITAL HOLTER RECORDER (K942781)Agilent Technologies1995-01-24
PRECISION UV(TM) (VASURFICON A) (K946012)Pilkington Barnes-Hind, Ltd.1995-01-24
PULPDENT ROOT CANAL SEALER (K946138)Pulpdent Corp.1995-01-20
PULPDENT CANAL FINDER (K945811)Pulpdent Corp.1995-01-20
BOLUS DISPENSER (K935811)I-Flow Corp.1995-01-20
FUJI DUET (K946100)GC America, Inc.1995-01-20
INNOVA PELVIC FLOOR STIMULATION SYSTEM (K941911)Empi1995-01-20
DYNAMEDICS ASAR (K941083)Dynamedics Corporation1995-01-20
JPI X-RAY FILM CASSETTE (K945328)Jpi America, Inc.1995-01-20
V-CATH BREAKAWAY NEEDLE INTRODUCER (K945473)Hdc Corp.1995-01-20
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER (K943505)Hologic, Inc.1995-01-20
GENERA 100 SURGICAL SYSTEM (K945181)Xintec Corporation1995-01-20
LEKSELL SURGIPLAN (K943468)Elekta Instruments, Inc.1995-01-20
CANAL KING (THIN) CANAL KING (THICK) (K940368)Pulpdent Corp.1995-01-20
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (K942222)Isolab, Inc.1995-01-20
TSRH SPINAL SCREWS (K932029)Sofamor Danek Mfg., Inc.1995-01-20
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (K946238)Symbiosis Corp.1995-01-20
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM (K943853)Wrightmedicaltechnologyinc1995-01-20
BATTERY PACK #PMX120-18A (K945043)Portable Power Systems, Inc.1995-01-20
IMAGYN MICROLAP(TM) LAPAROSCOPE (K944079)Imagyn Medical, Inc.1995-01-20
SPECIFIC IGE EIA-ULTRA ASSAY (K941057)Hycor Biomedical, Inc.1995-01-20
CUEVA CRANIAL NERVE ELECTRODE (K944061)Ad-Tech Medical Instrument Corp1995-01-20
HORMANN HEARING INSTRUMENTS (K945219)Hormann, Inc.1995-01-20
DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT (K945831)Micromed Development Corp.1995-01-20
QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (K942276)Isolab, Inc.1995-01-20
IGM RF EIA (K942908)Sigma Diagnostics, Inc.1995-01-20
JPI X-RAY GRID (K945327)Jpi America, Inc.1995-01-20
ANTI-HISTONE ANIBODY TEST (K943585)Immco Diagnostics, Inc.1995-01-20
MODELS 4100 AND 4300 MULTITHERAPY (K945954)Spinalight, Inc.1995-01-19
CDH HIP STEM (K945096)Howmedica Corp.1995-01-19
CRIT-LINE BLOOD CHAMBER WITH E-BEAM (K935958)In-Line Diagnostics Corp.1995-01-19
APC FEMORAL COMPONENT (K945095)Howmedica Corp.1995-01-19
SENTRY TOTAL HIP (K945089)Howmedica Corp.1995-01-19
DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM (K940519)Dideco1995-01-19
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Track 1995 automatically

Every clearance here is in the API, with alerts when new ones post.