Atlas FDA

1997

4,309 FDA 510(k) clearances · Clearance year

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RecordFirmDate
IMMERGE IMAGE CORRELATION (K970623)Surgical Navigation Technologies, Inc.1997-04-28
AS/3 NMT MODULE (K955026)Datex Medical Instrumentation, Inc.1997-04-28
CAP-35B III/CINE 275 (K971128)Jamieson Film Co.1997-04-28
MODEL 1920 WASTE GAS SCAVENGER (K963601)G. Dundas Co.1997-04-28
ADVENTURER (K971142)T.E.S., Ltd.1997-04-28
NATURE'S CRADLE (K970334)Infant Advantage, Inc.1997-04-25
SPACELABS MEDICAL ECG ANALYSIS SYSTEM (K962930)Spacelabs Medical, Inc.1997-04-25
DRAGER INCUBATOR 8000 IC (K954204)Drager, Inc.1997-04-25
F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM (K970380)Pyng Medical Corp.1997-04-25
MODIFIED E-PACK PROCEDURE KIT (K970317)ETHICON, Inc.1997-04-25
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA (K970607)Universal Reagents, Inc.1997-04-25
ACCULINE PREGNANCY TEST (K971122)Genix Biotek, Inc.1997-04-25
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA (K970593)Universal Reagents, Inc.1997-04-25
SATURNE MULTILEAF COLLIMATOR (K970303)General Electric Co.1997-04-25
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT (K964762)Beckman Instruments, Inc.1997-04-25
PARAMAX SALICYLATE REAGENT (K964715)Dade Intl., Inc.1997-04-25
VENTANA ANTI-S100 PRIMARY ANTIBODY (K941514)Ventana Medical Systems, Inc.1997-04-25
ETEST SPARFLOXACIN (K970820)Ab Biodisk1997-04-25
SIMPLEX TENS (K953982)Armstrong Industries, Inc.1997-04-25
VSA 3000 VIBRATORYN SENSORY ANALYZER (K970180)Eare Consulting Service1997-04-25
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) (K964766)Beckman Instruments, Inc.1997-04-25
VANTAGE PERIPHERAL DILATATION CATHETER (K965183)Guidant Corp.1997-04-24
JUPITER PTA CATHETERS (VARIOUS) (K970299)Cordis Corp.1997-04-24
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE (K963989)Cardiovascular Dynamics, Inc.1997-04-24
ACUPUNCTURE NEEDLES (K970574)C.A.I. Industries Corp.1997-04-24
FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS (K963991)Full Spectrum, Inc.1997-04-24
(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400 (K963996)Full Spectrum, Inc.1997-04-24
PYR SWAB (K970832)Remel, Inc.1997-04-24
SAFE-CATH (K960764)Scientific Device Manufacturer, LLC1997-04-24
SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM (K962882)Siemens Medical Solutions USA, Inc.1997-04-24
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM (K970392)Cordis Corp.1997-04-24
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) (K970519)Unitron Industries, Inc.1997-04-24
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM (K970697)Osteonics Corp.1997-04-24
ACCESSORIES TO THE STEREOTACTIC BODY FRAM (K970291)Elekta Instrument AB1997-04-24
COPALIS TORC TOTAL ANTIBODY ASSAY (K970931)Sienna Biotech, Inc.1997-04-24
IMMULITE TOXOPLASMA QUANTITATIVE IGG (K962936)Diagnostic Products Corp.1997-04-24
CLINICAL DIAGNOSTIC SOFTWARE (K970288)Nuccardiac Software, Inc.1997-04-24
EVS (K963886)Applied Medical Resources1997-04-24
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM (K965139)Carl Zeiss, Inc.1997-04-23
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (K970969)The Kendal Co.1997-04-23
LIQUID LIGAND 1,2,3 (K971071)Chiron Diagnostics Corp.1997-04-23
MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT (K970341)Medtronic PS Medical1997-04-23
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS (K971014)Lifescan, Inc.1997-04-23
MONARCH IOL DELIVERY SYSTEM (K970033)Alcon Laboratories1997-04-23
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW (K970292)Influence, Inc.1997-04-23
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (K964152)Pharmacia, Inc.1997-04-23
SMITH & NEPHEW MIS INSTRUMENTS (K970949)Smith & Nephew Endoscopy, Inc.1997-04-23
QA-ES (K971092)Smith1997-04-23
EZ-CIRC (K963223)Phyllis Adams, Rn, Npc, Msn1997-04-23
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT (K964756)Wano-Tech Corp.1997-04-23
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (K970930)Cleft Palate Appliances, Inc.1997-04-23
CALL-RAD PC TELERADIOLOGY (K964288)Pc Teleradiology1997-04-23
KENDALL HYDROPHILIC POWDER WOUND DRESSING (K970266)Kendall Healthcare Products Co. Div.Of Tyco Health1997-04-23
SERVOTRONIC EC100 SYSTEM (K962087)Medicon, Inc.1997-04-23
THERMAL REGULATION SYSTEM BLANKET (K964377)Gibeck, Inc.1997-04-23
PUNCTUAL OCCLUDER (K970631)Odyssey Medical, Inc.1997-04-23
E-Z SPACER MASK (SMALL) (K964956)Airpharma, LLC1997-04-23
CHASE RETROGRADE CARDIOPLEGIA CANNULA (K964393)Chase Medical, Inc.1997-04-23
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K965095)Ansell Edmont Industrial, Inc.1997-04-22
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES (K970764)Comeg Endoscopy1997-04-22
IMT LOUPE-COLPOSCOPE (K963593)Inventive Medical Technology1997-04-22
COAGUCHEK PST SYSTEM (K962571)Boehringer Mannheim Corp.1997-04-22
PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K963850)Deknatel, Inc.1997-04-22
EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS) (K964440)Maxxim Medical1997-04-22
RESECTOSCOPE CUTTING LOOP ELECTRODE (K964365)Omnitech Systems, Inc.1997-04-22
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY (K941170)Ventana Medical Systems, Inc.1997-04-22
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM (K970394)Osteonics Corp.1997-04-22
MINNOVA PELVIC FLOOR STIMULATION SYSTEM (K970307)Empi1997-04-22
VINYL EXAM GLOVE POWERED (K970144)Hiyi Export Co.1997-04-22
COMFORT CATH CHOICE MALE EXTERNAL CATHETER (K970966)Sierra Laboratories, Inc.1997-04-22
HYDRAGEL 15 HB A1C KIT (K963844)Morax1997-04-22
SONOS 2000, SONOS 2500 (M2406 A) (K964309)Hewlett-Packard Co.1997-04-22
TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT (K963731)Enthermics Medical Systems, Inc.1997-04-22
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM (K964742)Aziz Y. Anis, M.D.1997-04-22
PROSELECT 3 PERIDONTAL THERAPY SYSTEM (K964596)Professional Dental Mfg., Inc.1997-04-22
CARD GUARD MODEL CG-900 (K960553)Card Guard Scientific Survival , Ltd.1997-04-22
SAFE-CONNECT I.V. EXTENSION SET (K970524)Faulding Medical Device Co.1997-04-22
EQUI-PISE 1000 MRS (K970350)Advanced Air Support Consultancy, Inc.1997-04-22
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (K970314)Beckman Instruments, Inc.1997-04-21
EVT MARKER BOARD (K970608)Guidant Cardiac and Vascular Surgery1997-04-21
WAKO TOTAL BILIRUBIN V (K970985)Wako Chemicals USA, Inc.1997-04-21
GSI CANNULA WITH INTRODUCER (K970201)General Surgical Innovations1997-04-21
MINI SAMPLER PROCESSOR (K970616)Cavro Scientific Instruments, Inc.1997-04-21
ACUFEX DOUBLE ARMED SUTURE NEEDLE (K970416)Smith & Nephew Endoscopy, Inc.1997-04-21
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM (K964254)Sofamor Danek USA,Inc.1997-04-21
VAIL 3000 BED ENCLOSURE (K963589)Vail Products, Inc.1997-04-21
URIC ACID REAGENT (K970867)Derma Media Lab., Inc.1997-04-21
LIQUID GLUCOSE (OXIDASE) REAGENT SET (K970781)Pointe Scientific, Inc.,1997-04-21
ALT OR SGPT (K971323)Carolina Liquid Chemistries Corp.1997-04-21
ULTRACELL NEURO SPONGES (K970328)Ultracell Medical Technologies, Inc.1997-04-21
INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP (K970754)Innerdyne, Inc.1997-04-21
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER (K971255)Imagyn Medical, Inc.1997-04-21
VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY (K970205)Austenal, Inc.1997-04-21
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY (K941707)Ventana Medical Systems, Inc.1997-04-21
SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT (K971363)Carolina Liquid Chemistries Corp.1997-04-21
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT (K965033)Beckman Instruments, Inc.1997-04-21
CT-MODELLER SYSTEM (K970617)Materialise NV1997-04-21
TRIGLYCERIDES (K971005)Derma Media Lab., Inc.1997-04-21
IN THE EAR HEARING AID (K964898)Keytone Hearing Laboratory1997-04-21
ARTOS, DIPLOS SYSTEM (K970284)Turnkey Intergration USA, Inc.1997-04-21
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Every clearance here is in the API, with alerts when new ones post.