Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KD ONE-STAGE PROTHROMBIN TIME TEST (K883640)King Diagnostics, Inc.1988-10-31
BEHRING TURBITIMER (K883646)Behring Diagnostics, Inc.1988-10-31
INSULIN SYRINGE (K883078)Select Sources, Inc.1988-10-31
PL 20/20 INFANT VISION TESTER (K883337)Optimed Technologies, Inc.1988-10-31
ONE-STEP HCG (K882896)Wampole Laboratories1988-10-31
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER (K883699)Fonar Corp.1988-10-31
SIEMENS PACS/I-A (K880690)Siemens Gammasonics, Inc.1988-10-31
ROCKET INTRAUTERINE SOUND (K883806)A & A Medical, Inc.1988-10-31
IMMUNOCCULT-LXI (K883432)Intl. Immunoassay Laboratories, Inc.1988-10-31
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT (K882629)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-31
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE (K883765)Biotecx Laboratories, Inc.1988-10-31
PISTON SYRINGE WITH NEEDLE (K883033)Select Sources, Inc.1988-10-31
UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4 (K883961)Unimax Hearing Instruments1988-10-31
MEDITRON ENDOLAV MODEL EL-100 (K882048)Xylog Corp.1988-10-31
HI CHEM KINETIC CHOLESTEROL REAGENT #88218 (K883844)Hichem Diagnostics1988-10-31
PRN PLUS + INFUSION SET (K884053)Prn Services, Inc.1988-10-31
BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM (K883256)Bio Clinic Co.1988-10-31
PERMANENT PACING LEADS PYBJ SERIES (K882345)Oscor Medical Corp.1988-10-28
COMPAT ENTERAL DELIVERY SYSTEM (K882682)Sandoz Nutrition1988-10-28
0.014 PERIPHERAL GUIDE WIRE (K882804)Intensive Technology, Inc.1988-10-28
PORGES STEPPED NEOPLEX DILATOR (K883526)Porges Corp.1988-10-28
PMT 3721-1 EPIDURAL KIT (K883314)Progress Mankind Technology1988-10-28
3D VASCULAR RECORDER (K883908)D. E. Hokanson, Inc.1988-10-28
ROTATING HEMOSTATIC VALVE (K883916)Devices For Vascular Intervention, Inc.1988-10-28
PERMANENT PACING LEAD MODEL RXBJ SERIES (K882462)Oscor Medical Corp.1988-10-28
BIO-MEDICUS TUBING CONNECTORS (K883956)Bio Medicus, Inc.1988-10-28
BM-103 BATTERY MODULE (K883877)Datex Division Instrumentarium Corp.1988-10-28
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. (K884167)Technical Medical Products, Inc.1988-10-28
SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM (K883058)Solco Basle, Inc.1988-10-28
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (K884147)Orion Diagnostica, Inc.1988-10-27
MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10) (K883371)3M Company1988-10-27
MICROMEDIC FERRITIN IRMA KIT (K883746)Icn Micromedic Systems1988-10-27
INFUSA-PLATE (K883902)Kalajian Ent.1988-10-27
SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM (K883187)Intl. Health Technology, Inc.1988-10-27
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) (K883949)Immco Diagnostics, Inc.1988-10-27
MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS (K884311)Surgilase, Inc.1988-10-27
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) (K883883)Immco Diagnostics, Inc.1988-10-27
SCEPTORPETTE SYSTEM (K883907)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-27
MODIFIED MODEL 2001 FIBER OPTICS CATHETER (K883881)Metatech Corp.1988-10-27
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (K884074)Orion Diagnostica, Inc.1988-10-27
MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS (K884313)Surgilase, Inc.1988-10-27
CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY (K884185)Ciba Corning Diagnostics Corp.1988-10-27
CONDOMS (RAMSES, SHEIK AND KOROMEX) (K882893)Schmid Laboratories, Inc.1988-10-26
PEDIATRIC HOSPITAL BED (K881843)The Medical Group, Inc.1988-10-26
GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT (K884052)Professional Service Unltd.1988-10-26
THE SAXON SPERMICIDAL CONDOM (K883467)Circle Rubber Corp.1988-10-26
SMI 3000 AIRBED (K883192)Smi Patientcare, Inc.1988-10-26
MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS (K884165)Spark Instruments & Academics, Inc.1988-10-26
CHEM 1 UIBC (IRON BINDING CAPACITY TEST) (K883104)Technicon Instruments Corp.1988-10-25
STREPSLIDE (K882811)Ncs Diagnostics, Inc.1988-10-25
RUBELLA IGM MICROASSAY (K883778)Diamedix Corp.1988-10-25
PERMA PURE NAFION TUBE DRYER-MODEL ME (K881264)Perma Pure Products, Inc.1988-10-25
ADD-A-CATH (K884061)Femcare , Ltd.1988-10-25
FDL ELISA FOR CHLAMYDIA (K883266)Fairleigh Dickinson Laboratories, Inc.1988-10-25
ROCHE REAGENT FOR CALCIUM (K883453)Roche Diagnostic Systems, Inc.1988-10-25
OXALATE REAGENT (K883525)Sigma Chemical Co.1988-10-25
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (K884208)Oxoid U.S.A., Inc.1988-10-25
I-SPOSE EYE SHIELD (K883658)Products For Medicine1988-10-25
REDY 2000 (K882428)Organon Teknika Corp.1988-10-25
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME (K883479)Baxter Healthcare Corp1988-10-25
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. (K883975)Site Microsurgical Systems, Inc.1988-10-25
FIBER OPTIC LARYNGOSCOPE (K883830)Effner, Inc.1988-10-25
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K883083)Medical Diagnostic Technologies, Inc.1988-10-25
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II (K882486)Bio-Rad1988-10-25
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST (K883321)Heraeus Kulzer, Inc.1988-10-25
QLIA T UPTAKE ASSAY (K883971)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-25
DISCOVER(R) (K882232)Carter Products1988-10-25
KRATZ NOVA SERT(TM) (K883489)Coopervision-Cilco1988-10-25
BILIRUBIN STANDARD (K882059)Verichem Laboratories, Inc.1988-10-25
SNAP N' STAIN IODINE STAIN (K884069)Scientific Device Laboratory, Inc.1988-10-25
PMD SYSTEM-20 (K883390)Datatek, Inc.1988-10-25
DENTA PLUS (K883403)Connoisseurs Products Corp.1988-10-25
MODIFIED REUSABLE SITE FIBER OPTIC CABLE (K883605)Site Microsurgical Systems, Inc.1988-10-25
UVP VOLUMED 2001 (K881079)Ferguson Medical1988-10-25
CDT CYTOTOXI TEST (K883560)Advanced Clinical Diagnostics1988-10-25
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION (K883173)KARL STORZ Endoscopy-America, Inc.1988-10-25
#875 DISPOSABLE BIOPOLAR CABLE (K884171)Olsen Electrosurgical, Inc.1988-10-24
MODIFIED OLSEN 755/756 SWITCHPENS (K884174)Olsen Electrosurgical, Inc.1988-10-24
MODIFIED OLSEN #770 DISPOSABLE HOLSTER (K884172)Olsen Electrosurgical, Inc.1988-10-24
#920 DISPOSABLE TUR CABLE (K884173)Olsen Electrosurgical, Inc.1988-10-24
BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 (K883131)Advanced Mechanical Technology, Inc.1988-10-24
BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 (K883130)Advanced Mechanical Technology, Inc.1988-10-24
BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 (K883129)Advanced Mechanical Technology, Inc.1988-10-24
GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) (K884195)Mumtaz I. Malik1988-10-24
#820/821 BIPOLAR FORCEPS (K884175)Olsen Electrosurgical, Inc.1988-10-24
BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM (K883198)Advanced Mechanical Technology, Inc.1988-10-24
CARETEX CENTRAL SUPPLY WRAP (K883802)James River Corp.1988-10-21
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 (K883644)Baxter Healthcare Corp1988-10-21
MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR (K884080)Fenem, Inc.1988-10-21
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 (K883534)Baxter Healthcare Corp1988-10-21
MICRO-X 100CP (K884134)Fischer Imaging Corp.1988-10-21
COMFORT STRAP (K884149)Comfort Strap Co.1988-10-21
VALLEYLAB I.V. ADMINISTRATION SETS (K883318)Valleylab, Inc.1988-10-21
REPORT AND IMAGE MANAGEMENT SYSTEM (K882754)Medical Image Processing Specialists, Inc.1988-10-21
MOUTH-TO-MASK VENTILATORY ADJUNCT (K883766)Medic One1988-10-21
INTROCULAR FLUID INJECTOR (K881707)B&B Medical Assoc., Inc.1988-10-21
GENESIS 180 (K883863)Fischer Imaging Corp.1988-10-21
HIMOBILIX 2N (K883161)Bay X-Ray, Inc.1988-10-21
BARD URETEROSCOPIC DEVICE (K883110)C.R. Bard, Inc.1988-10-21
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS (K883239)Baxter Healthcare Corp1988-10-21
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Every clearance here is in the API, with alerts when new ones post.