Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE (K901810)Neuro Technology1991-05-30
ZEFON BATERIAL/VIRAL FILTER (K911651)Bill Olson Corp.1991-05-30
MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11 (K910758)Technology Transfer Intl., Inc.1991-05-30
MICREL LTD-PORTABLE INFUSION PUMP-MP20Q (K910350)Technology Transfer Intl., Inc.1991-05-30
ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (K911843)Steridyne Corp.1991-05-30
BARD SINGULAR BIOPSY FORCEPS (K912214)C.R. Bard, Inc.1991-05-30
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION (K911642)Hitachi Medical Systems America, Inc.1991-05-30
RIVER MEDICAL MICRODRILL SYSTEM (K905437)River Medical, Inc.1991-05-30
PULPDENT DIAMOND POLISH (K911284)Pulpdent Corp.1991-05-30
THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST (K911821)Dentecon, Inc.1991-05-30
JAIN QUICK COUNT (K911076)Jain Surgical Equipment, Inc.1991-05-30
COM-TENS: A NEUROSTIMULATOR (K902102)Apex Medical, Inc.1991-05-30
ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL (K896596)Instrumentarium Imaging, Inc.1991-05-30
COMPUTE-RX-COMP (TM) (K910367)Medicalibration Physics Consultant Services, Inc.1991-05-30
ULTRALITE PANELITE (K910091)Ultralite1991-05-30
FACEPLATE ITE HEARING AID MODEL 28A (K910901)Telex Communications, Inc.1991-05-30
FACEPLATE ITE HEARING AID MODEL TCA (K910900)Telex Communications, Inc.1991-05-30
LIGAMENTOPLASTIC STAPLE OF L'UNION (K911020)Sport Service, Inc.1991-05-29
DCW MODULAR DISTAL FEMORAL SYSTEM (K910596)Dow Corning Wright1991-05-29
NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS (K911227)3M Health Care, Sarns1991-05-29
GAMMAT ELECTROFORMED GOLD COPING (K911042)Gramm Surface Technology, Inc.1991-05-29
PLATE BLADE WITH CURSOR OF L'UNION (K911021)Sport Service, Inc.1991-05-29
ADHESIVE PRECOATED BRACKETS (K911271)Unitek Corp.1991-05-29
SGARLATO FLEXIBLE HINGE TOE IMPLANT (K905795)Sgarlato Laboratories, Inc.1991-05-29
VENA CAVA FILTER (K901454)Vena-Tech, Inc.1991-05-29
MEDTRACK TREADMILL (K911751)Quinton, Inc.1991-05-29
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP (K910873)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-05-29
POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM (K911151)Tarsys Engineering, Inc.1991-05-29
PALFIQUE ESTELITE (K911524)Tokuyama America, Inc.1991-05-29
STEALTH CATHETER SYSTEM (K911089)Target Therapeutics1991-05-29
STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION (K911026)Sport Service, Inc.1991-05-29
AVD INTIMAX OCCLUSION CATHETER (K910339)Applied Vascular Devices, Inc.1991-05-29
ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION (K910627)Foremost Mfg., Inc.1991-05-29
THE TRAMOND PIN (K911031)Sport Service, Inc.1991-05-29
7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE (K910987)Scimed1991-05-29
HYPERGEL PROTECTIVE WOUND GEL (K905439)Scott Health Care1991-05-29
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG (K911106)Baxter Healthcare Corp1991-05-28
MOSS NASAL TUBE MARK IV (K910912)Moss Medical Products1991-05-28
ABBOTT LIFECARE 5000 PUMP (K911401)Abbott Laboratories1991-05-28
MINIOX V PULSE OXIMETER (K905310)Catalyst Research Corp.1991-05-28
FLOWPLUS AC330 PUMP GARMENTS (K910188)Huntleigh Technology, Inc.1991-05-28
3M 6830 ELECTRODE (K905539)3M Healthcare1991-05-28
SATLITE PLUS PULSE OXIMETER (K905140)Datex Division Instrumentarium Corp.1991-05-28
AUTOCATH(TM) SET (K910876)Cook Urological, Inc.1991-05-28
PHILIPS INTEGRIS V3000 AND V4000 (K910370)Philips Medical Systems, Inc.1991-05-28
ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE (K901811)Neuro Technology1991-05-28
AMBU MATIC AUTOMATIC RESUSCITATOR (K904920)Ambu, Inc.1991-05-28
HSV-1 IGG ELISA TEST (K910954)Gull Laboratories, Inc.1991-05-28
STAK-CHEX (K911582)Streck Laboratories, Inc.1991-05-28
MEDI GUARD PILLOWCASE (K911948)Sancella, Inc.1991-05-28
HSV-2 IGG ELISA TEST (K910952)Gull Laboratories, Inc.1991-05-28
MEDI GUARD UNDERPAD (K911952)Sancella, Inc.1991-05-28
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT (K910040)Ambu, Inc.1991-05-28
HSV-2 IGM ELISA TEST (K910953)Gull Laboratories, Inc.1991-05-28
SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT (K904165)Occupational Preventive Diagnostics, Inc.1991-05-28
URAM OPHTHALMIC LASER ENDOSCOPE (K910532)Martin S. Knopf Assoc., Inc.1991-05-28
BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE (K911329)C.R. Bard, Inc.1991-05-28
HSV-1 IGM ELISA TEST (K910955)Gull Laboratories, Inc.1991-05-28
MX CYCLER (K905071)Dakmed, Inc.1991-05-28
MEDI GUARD SHEETS/UNDERLAYS (K911953)Sancella, Inc.1991-05-28
WIDEX MODEL QX IN-THE-EAR HEARING AID (K912169)Widex Hearing Aid Co., Inc.1991-05-28
L328 TRANSDUCER (K905456)Acuson Corp.1991-05-28
SR1 ESTRADIOL ENZYME IMMUNOASSAY (K911396)Serono-Baker Diagnostics, Inc.1991-05-28
ND:YAG LASER SYSTEMS (VARIOUS MODELS) (K910805)Heraeus Lasersonics, Inc.1991-05-24
SRI TSH IMMUNENZYMETRIC ASSAY (K910837)Serono-Baker Diagnostics, Inc.1991-05-24
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION (K911954)Bio-Rad1991-05-23
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL (K910563)Johnson & Johnson Orthopaedics, Inc.1991-05-23
TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY (K911198)Orthomet, Inc.1991-05-23
ONE STEP BUTTON(TM) (K910584)Applied Medical Technologies1991-05-23
TL100W/01 UVB LAMP (K910767)Philips Lighting Co.1991-05-23
LM-150HT LIGHT SOURCE (K911212)Leisegang Medical, Inc.1991-05-23
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE (K911438)Bio-Tek Instruments, Inc.1991-05-23
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON (K904870)Endotec, Inc.1991-05-23
INNOFLUOR VALPROIC ACID CALIBRATOR SET (K911466)Intl. Bioclinical, Inc.1991-05-23
ABBOTT LIFECARE 5000 PUMP MODIFIED (K910919)Abbott Laboratories1991-05-23
SMALL INSTRUMENT STERILIZATION/BUR BOX (K910794)Brevet, Inc.1991-05-23
ALDETECT (K905779)Pochemco, Inc.1991-05-23
HOWMEDICA(R) CEMETED FEMORAL COMPONENT (K910869)Howmedica Corp.1991-05-23
PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM (K911197)Orthomet, Inc.1991-05-23
CARDIOCAP II TM CH-RESP MONITORS (K904355)Instrumentarium Corp.1991-05-23
STRYKER ARTHROSCOPIC INFUSION PUMP (K910858)Stryker Corp.1991-05-23
SERIES 7000 CARBON DIOXIDE MODULE (K904789)Marquette Electronics, Inc.1991-05-22
MILENIA PROGESTERONE (K911512)Diagnostic Products Corp.1991-05-22
ACTH IRMA KIT MITSUBISHI YUKA (K910178)Science Regulatory Services Intl.1991-05-22
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION (K911724)E.I. Dupont DE Nemours & Co., Inc.1991-05-22
NEBU-SOL METERED DOSE DISPENSER (TM) (K910239)Dey Laboratories, Inc.1991-05-22
HDL CHOLESTEROL REAGENT (K911406)Genzyme Corp.1991-05-22
CARDIOPULMONARY BYPASS PUMP TUBING (K910021)Jtl Medical Corp.1991-05-22
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE (K910980)Site Microsurgical Systems, Inc.1991-05-22
OSMOMETER MODEL 2400 (K911092)Advanced Instruments, Inc.1991-05-22
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE (K911755)Bionostics, Inc.1991-05-22
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY (K911062)Storz Instrument Co.1991-05-22
SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. (K911766)Gall'S, Inc.1991-05-22
CATHCAP, CAT. NO. CC100 SERIES (K911519)Gish Biomedical, Inc.1991-05-22
SPIROSIFT 500A (K904200)Fukuda Denshi USA, Inc.1991-05-22
WALLACH COLD SOAKER (K910491)Wallach Surgical Devices, Inc.1991-05-21
AUTOMASTER (K904934)Team Mfg., Inc.1991-05-21
WHEELCHAIR CONVERSION KIT (K904650)Hadco Marketing Services, Inc.1991-05-21
TARGET ASO TEST (K910073)Texas Immunology, Inc.1991-05-21
JACKSON MULTIPURPOSE OPERATING TABLE (K910736)Orthopedic Systems, Inc.1991-05-21
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Every clearance here is in the API, with alerts when new ones post.