Atlas FDA

1992

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

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RecordFirmDate
FILTERMATE UNIVERSAL HARVESTER (K924907)Packard Instrument Co., Inc.1992-12-01
HEMOCARD(TM) CONTROL (K924173)Isolab, Inc.1992-12-01
CLIBRATION PLASMAS (K924404)Behring Diagnostics, Inc.1992-12-01
VENTREX ALLERGEN DISC (K924044)Hycor Biomedical, Inc.1992-12-01
NEBULIZER SYSTEM (K922623)Healthdyne, Inc.1992-12-01
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL (K924843)General Biometrics, Inc.1992-12-01
ENCORE SM (K921572)Clark Laboratories, Inc.1992-12-01
VENTILATOR ADULT STAR MODIFICATION (K922654)Infrasonics Corp.1992-12-01
CLOTTING FACTOR V DEFICIENT PLASMA (K924394)Behring Diagnostics, Inc.1992-12-01
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) (K913714)Life Design Systems, Inc.1992-12-01
MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR (K924545)Mod Mode Medical1992-12-01
SYN ELISA DSDNA ANTIBODIES (K921132)Elias U.S.A., Inc.1992-12-01
SORIN MONOLYRH INTEGRATED MEMBRANE LUNG (K922933)Sorin Biomedica, Fiat, USA, Inc.1992-11-30
NUCLEAR MEDICINE LASER IMAGER (K923536)General Scanning, Inc.1992-11-30
AUTOZYME (K922241)Cambridge Life Sciences Plc.1992-11-30
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (K924257)Serono-Baker Diagnostics, Inc.1992-11-30
VIDAS FREE THYROXINE(FT4) ASSAY (K925177)Biomerieux Vitek, Inc.1992-11-30
SYNELISA CARDIOLIPIN ANTIBODIES (K924421)Elias U.S.A., Inc.1992-11-30
DELFIA HTSH ULTRA KIT (K923401)Wallac OY1992-11-30
ULTRACELL NASAL PACKING (K920358)Ultracell Medical Technologies, Inc.1992-11-30
OLYMPUS DIRECT BILIRUBIN REAGENT (K924963)Olympus Corp.1992-11-30
VENTREX ALLERGEN DISC (K924119)Ventrex, Inc.1992-11-30
ANTIMICROBIAL SUSCEPTIBILITY TEST (K924500)Alamar Biosciences Laboratory, Inc.1992-11-30
VENTREX ALLERGEN DISC (K924209)Hycor Biomedical, Inc.1992-11-30
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK (K924846)Remel Co.1992-11-30
RADIOGRAPHIC FILM MARKETING SYSTEM (K924345)Fischer Imaging Corp.1992-11-27
BODY BAND RESTRAINT STRAP SET (K923107)Cook, Inc.1992-11-27
PULMOCATH INTRABRONCHIAL CATHETER (K901615)Omnitron Intl., Inc.1992-11-27
SIGNA BREAST COIL AND ARRAY ACCESSORY (K923025)GE Medical Systems1992-11-27
ACUSON V714OR TRANSDUCER (K921341)Acuson Corp.1992-11-27
PLATO RADIATION THERAPY PLANNING SYSTEM (K921991)Nucletron-Oldelft Corp.1992-11-27
MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER (K922286)Norland Corp.1992-11-27
IES, IMAGE ENHANCEMENT SYSTEM (K922470)Open Mri, Inc.1992-11-27
EXPOSET (K922977)S & S Inficon, Inc.1992-11-27
VG-A MIG (K924229)Vortech Data, Inc.1992-11-27
SENS-A-RAY (K923067)Regam Medical Systems1992-11-27
AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 (K924430)Alphatek Corp.1992-11-27
DRAGER DVE 4000 SERIES SYSTEM (K921297)Alm Surgical Equipment, Inc.1992-11-27
UROLOGICAL C-ARM TABLE, MODEL #056-450 (K922591)Biodan Medical Systems, Ltd.1992-11-27
VENA CAVA FILTER SYSTEMS, MODIFICATION (K925679)B. Braun Vena-Tech1992-11-27
COFFMAN IMPLANT TOMOGRAPH (K924130)Coffman Dental1992-11-27
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV (K924604)Storz Instrument Co.1992-11-27
SEGAL REUSABLE ELECTRODE (K922999)Bernsco Surgical Supply, Inc.1992-11-27
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90 (K925175)Shimadzu Medical Systems1992-11-27
KODAK X-OMAT FS-1A PROCESSOR (K923552)Eastman Kodak Company1992-11-27
TAHOE SUCTION IRRIGATOR (K911238)Tahoe Pro Instruments1992-11-27
SHIMADZU RADIOGRAPHIC TABLE BK-100 (K925174)Shimadzu Medical Systems1992-11-27
PRO-CHILL STIMPACK (K912210)Tko, Inc.1992-11-27
BENNETT X-RAY ID PLUS (K925332)Bennett X-Ray Technologies1992-11-27
GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP (K924349)General Electric Co.1992-11-27
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 (K925203)Heraeus Kulzer, Inc.1992-11-25
OLYMPUS BUN REAGENT (K924693)Olympus Corp.1992-11-25
MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES (K922522)Sherwood Medical Co.1992-11-25
PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER) (K922515)Wembley Rubber Products (M) Sdn Bhd1992-11-25
SYMBIOSIS SUCTION-IRRIGATOR (K923563)Symbiosis Corp.1992-11-25
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 (K924259)Medix Biotech, Inc.1992-11-25
TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (K924645)Unitek Corp.1992-11-25
SURECATH PORT ACCESS CATHETER (K920036)Ivion Corp.1992-11-25
ULTRA LOW POROSITY DACRON WOVEN PATCH (K921659)Intervascular, Inc.1992-11-25
MCKERNAN ATRAUMATIC FORCEPS (K925041)Aslan Medical Technologies, Ltd.1992-11-25
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 (K924572)Em Diagnostic Systems, Inc.1992-11-25
NEEDLE (K924102)United States Endoscopy Group, Inc.1992-11-25
PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION (K923832)Kabi Pharmacia, Inc.1992-11-25
3M CURING LIGHT XL 3000 (K924812)3M Company1992-11-25
ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM. (K922424)Access Surgical Intl., Inc.1992-11-25
ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (K924373)Instrumed, Inc.1992-11-25
MORREY ELBOW FIXATOR (K910993)Howmedica Corp.1992-11-25
IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) (K924360)Impra, Inc.1992-11-25
GLENROE BAND SEATING CONTOURING INSTRUMENT (K924993)Glenroe Technologies1992-11-25
HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS (K923896)Heraeus Lasersonics, Inc.1992-11-25
DEXIDE LAPAROSCOPIC ACCESSORIES (K923845)Dexide, Inc.1992-11-25
MODEL 2000 DENTAL AIR ABRASIVE SYSTEM (K921748)Texas Airsonics, Inc.1992-11-25
P54 HEARING AID (K924888)Electone, Inc.1992-11-24
S-ROM TOTAL HIP REPLACEMENT SYSTEM (K920739)Joint Medical Products Corp.1992-11-24
CYTOLOGY BRUSH (K924104)United States Endoscopy Group, Inc.1992-11-24
ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS (K924115)Johnson & Johnson Orthopaedics, Inc.1992-11-24
TRUE/ FLEX FIBULA RODS (K924656)Applied Osteo Systems, Inc.1992-11-24
SNARE FLEXIBLE (K924105)United States Endoscopy Group, Inc.1992-11-24
SAPPHIRE PREMIERE (K923303)Medelec , Ltd.1992-11-24
STERILE FILM WOUND DRESSING (K924008)Innovative Technology , Ltd.1992-11-24
BIO-OSS BLOCKS (K920508)Geistlich-Pharma1992-11-24
INFRARED LAMP (K922900)Harrier, Inc.1992-11-24
PLANMED CYTOGUIDE (K923471)Planmed OY1992-11-24
INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE (K915696)Interspec, Inc.1992-11-24
DIAL-A-RAD PORTA RAD TABLE (K913425)Dial-A-Rad1992-11-24
POLY-DIAL INSERTS (K924492)Joint Medical Products Corp.1992-11-24
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT (K922905)W. L. Gore & Associates, Inc.1992-11-24
NEUROSIGN MODEL 100 (K923056)The Magstim Company , Ltd.1992-11-24
DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 (K924593)Philips Medical Systems, Inc.1992-11-24
TRUE/FLEX METATARSAL RODS (K924657)Applied Osteo Systems, Inc.1992-11-24
THE DENTIST'S TOOTH POLISHER (K924739)Ranir/Dcp Corp.1992-11-24
P54-0 BEHIND THE EAR HEARING AID (K924887)Electone, Inc.1992-11-24
BARD BILIARY BALLOON DILATORS (K920361)C.R. Bard, Inc.1992-11-24
LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE (K921408)Ultradent Products, Inc.1992-11-24
RLN NERVE LOCATOR/MONITOR; MODEL A (K925008)Rln Systems, Inc.1992-11-24
BIOPSY FORCEPS (K924106)United States Endoscopy Group, Inc.1992-11-24
TRANSORB(TM) ULCER & WOUND DRESSING (K922666)Brady Medical Products Co.1992-11-23
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 (K922269)The Heart Valve Div. Medtronic Cardiovascular Surg1992-11-23
SYNCHRON TOTAL PROTEIN TEST --MODIFIED (K922467)Beckman Instruments, Inc.1992-11-23
INMAN MEDICAL OIL EMULSION DRESSING (K921290)Inman Medical Corp.1992-11-23
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Track 1992 automatically

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