Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CDI(TM) 300, 400 & 100, MODIFICATION (K915255)3M Company1992-01-15
DIGITOXIN FPIA CALIBRATOR SET (K915464)Sigma Diagnostics, Inc.1992-01-15
DPI-1106 IMPLANT, MODIFICATION (K911776)Minimatic Implant Technology1992-01-15
AD-TECH EPIDURAL PEG ELECTRODE (K912760)Ad-Tech Medical Instrument Corp1992-01-15
PARI-MASTER (K912805)Paul Ritzau Pari GmbH1992-01-15
ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR (K915239)ETHICON, Inc.1992-01-15
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT (K914756)Medix Biotech, Inc.1992-01-15
ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT (K914853)Reads Medical Products, Inc.1992-01-15
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) (K914429)Diagnostic Systems Laboratories, Inc.1992-01-15
ABBOTT QUICKSTART TIGLYCERIDES REAGENT (K915732)Em Diagnostic Systems, Inc.1992-01-15
IVEX-TPN EXTENSION FILTER SET (K913308)Abbott Laboratories1992-01-15
HY-PREP SYSTEM (K913809)Hyperion, Inc.1992-01-15
CDI(TM) H/S CUVETTE, MODIFICATION (K915265)3M Company1992-01-15
CUSTOM CANAL HEARING AID (K915346)Dicta Laboratories1992-01-15
TRACH T ADAPTER (K913216)Specialty Packaging Producs, Inc.1992-01-15
NOVA 4 NA/K/C1/TCO2/LI ANALYZER (K915176)Nova Biomedical Corp.1992-01-15
CEDIA(R) CARBAMAZEPINE ASSAY (K914857)Microgenics Corp.1992-01-15
DOBBHOFF(R) SINGLE PASS PEG KIT (K913784)Biosearch Medical Products, Inc.1992-01-15
COLLINS DIGITAL PULMONARY MANOMETER (K912946)Warren E. Collins, Inc.1992-01-15
NON REBREATHING MASK (K913164)Specialty Packaging Producs, Inc.1992-01-15
MULTIPLE STERILE SURGICAL DRAPE PACK (K914605)Assured Surgical Products, Inc.1992-01-15
PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET (K914792)Filtertek, Inc.1992-01-15
TIA CRP TEST KIT (K914155)Crestat Diagnostics, Inc.1992-01-15
MARLOW LAPAROSCOPIC SCISSORS (K914869)Marlo Surgical Technology1992-01-15
PHOTAC-BOND APLICAP, MODIFICATION (K915005)Espe GmbH (Us)1992-01-14
KOPAN'S TARGET (K915417)Medical Device Technologies, Inc.1992-01-14
ELECTRODE USING PROMEON RG-60 SERIES GEL (K915333)Labeltape Meditect, Inc.1992-01-14
MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER (K910742)Graphic Controls Corp.1992-01-14
INTERSEGMENTAL TRACTION TABLE (K915784)Tjn Manufacturing,Inc.1992-01-14
L.C.S. 2000 SYSTEM (K914591)Stiefel Research Institute, Inc.1992-01-14
MANI DIA-BURS (K913651)The Lahr Consulting Group, Inc.1992-01-14
ORTHO LIGHT CURE (K913854)Ortho Source1992-01-14
SONO(R) -CEM (K913966)Espe GmbH (Us)1992-01-14
AMOENA AFFINITY MODEL #802 (K915382)Coloplast Corp.1992-01-14
OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES (K904940)Olympus Corp.1992-01-13
TI-FIT FEMORAL COMPONENT (K914343)Smith & Nephew Richards, Inc.1992-01-13
TRACHEOSTOMY MASK (K913501)B & F Medical Products, Inc.1992-01-13
PEGASUS LATERAL CARDIAC POSITIONER (K915592)Fischer Imaging Corp.1992-01-13
B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT (K915671)Progressive Medical Technology, Inc.1992-01-13
SELECTRA AND TUBING SETS (K910173)Medionics International , Ltd.1992-01-13
PHOENIX BURR HOLE BUTTON, BURR 1 (K913490)Phoenix Bioengineering, Inc.1992-01-13
EXACTECH CERAMIC FEMORAL HEAD COMPONENT (K914574)Exactech, Inc.1992-01-13
AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE (K915151)United States Surgical, A Division of Tyco Healthc1992-01-13
RIONET HEARING AID HB-71K (K-AMP) (K915875)Authorized Hearing Systems, Inc.1992-01-13
FOLDING WHEELCHAIR (K915108)Guardian Products Co., Inc.1992-01-13
ASL MODEL #104 (K914737)Adaptive Switch Laboratories, Inc.1992-01-13
OPTI-LENS(TM) CONTACT LENS CASE (K915082)Ryder Intl. Corp.1992-01-13
BANTEX BRAND WHEELCHAIRS (K915262)Bantex Corp.1992-01-13
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER (K914676)Zimmer, Inc.1992-01-13
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION (K914946)Helena Laboratories1992-01-13
MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X (K914938)Invacare Corp.1992-01-13
INTERLOCKING FEMORAL NAILING SYSTEM (K912930)Stryker Corp.1992-01-13
M170 PNEUMATICALLY OPERATED OSCILLATING SAW (K914845)Desutter Medical , Ltd.1992-01-13
BIODEX SYSTEM 2 AUTOPROGRAM (K915846)Biodex Corp.1992-01-13
OREGON FIXATION SCREW (K910976)Acu Med, Inc.1992-01-13
MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC (K913368)Fisher & Paykel Electronics , Ltd.1992-01-13
COWBOY (K913611)Kinetic Concepts, Inc.1992-01-13
LATEX PATIENT EXAMINATION GLOVES - HYPOALLERGENIC (K914709)Klh Medical, Inc.1992-01-10
OPTI-AMP (K914876)Intelligent Hearing Systems1992-01-10
MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL (K912803)Medical Sterilization, Inc.1992-01-10
MORSE ANESTHESIA (K905208)North American Instrument Corp.1992-01-10
PROPAQ 102,104,106,102EL,104EL,&106EL (K914838)Protocol Systems, Inc.1992-01-10
OXYGUARD (K914978)Stantex Pty , Ltd.1992-01-10
CHEMO-PORT (K913386)Hdc Corp.1992-01-10
UROVIEW 2000, MODIFICATION (K914446)Oec-Diasonics, Inc.1992-01-10
TURNSOFT MATTRESS (K913933)Turnsoft, Inc.1992-01-10
SONOTONE BEHIND THE EAR MODEL ST 54-0 (K914897)Sonotone Intl., Inc.1992-01-10
STERILE SUGICAL GOWN PACK (K914563)Assured Surgical Products, Inc.1992-01-10
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P (K914106)Pentax Precision Instrument Corp.1992-01-10
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P (K914008)Pentax Precision Instrument Corp.1992-01-10
CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (K914523)Catheter Research C/O Burditt, Bowles & Radzius1992-01-10
AMCATH DISPOSABLE BIOPSY FORCEPS (K915142)Intl. Medical, Inc.1992-01-10
GRUNDIG ELECTRONICS VARIOUS MODELS (K915232)Perkins Mfg. Co.1992-01-09
REMOVE ADHESIVE REMOVER (K915150)Smith & Nephew United, Inc.1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 53A (K915519)Sonotone Intl., Inc.1992-01-09
ARTHROSCOPY CAMERA DRAPE (K915214)O.R. Concepts, Inc.1992-01-09
ECHOSIGHT STENT SET (K914280)Cook Urological, Inc.1992-01-09
BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 (K914608)Dlp, Inc.1992-01-09
SONOTONE BODY AID MODEL ST 1000 BODY WORN (K915517)Sonotone Intl., Inc.1992-01-09
ABCOM 2000 (K912562)Applied Biometrics, Inc.1992-01-09
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION (K915684)Rexton, Inc.1992-01-09
LM- LAP 10 HIGH FLOW INSUFFLATOR (K914201)Leisegang Medical, Inc.1992-01-09
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 (K914255)Bio-Rad1992-01-09
GEN-X 800/300 (K915339)Swissray Finatech, Inc.1992-01-09
IL TEST(TM) HDL CHOLESTEROL (K914811)Instrumentation Laboratory CO1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 49 (K915518)Sonotone Intl., Inc.1992-01-09
PRESSURE INFUSER (K913751)Biomedical Dynamics, Inc.1992-01-09
GEN-X 800/500 (K915227)Swiss Ray Medical Systems1992-01-09
SC1150 CW/PD (K912819)Pie Medical Equipment B.V.1992-01-09
STAR SYNC, MODIFICATION (K913972)Infrasonics Corp.1992-01-09
RANGEROLLER (K915152)Excel Mobility Products, Inc.1992-01-09
K-CAP-E, STERILE (K914812)Westcon Orthopedics, Inc.1992-01-09
MED-EQUIP CORPORATION (K915076)Medequip Co.1992-01-09
MODEL SONICAID AXIS (K912890)Oxford Medilog, Inc.1992-01-09
DSL INSULIN RIA (DSL 1600) (K914820)Diagnostic Systems Laboratories, Inc.1992-01-09
CONVERTRAY, MODIFICATION (K912001)Wilde Dental (Usa)1992-01-09
712 PLASTIC SURGERY TABLE & ACCESORIES (K915141)Midmark Corp.1992-01-09
BIODEX SYSTEM 2 AUTOPROGRAM (K915648)Biodex Corp.1992-01-09
RIONET HEARING AID HB-52AS (K915319)Rion Co. Ltd. Dba Rion Acoustic Device1992-01-09
CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND (K912776)Cardio Metrics, Inc.1992-01-09
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Every clearance here is in the API, with alerts when new ones post.