Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AVL OPTI CRITICAL CARE ANALYZER (K974784)Avl Scientific Corp.1998-02-24
HERMES OPERATING ROOM CONTROL CENTER (K973700)Computer Motion, Inc.1998-02-24
MDA SIMPLASTIN HTF (K974566)Organon Teknika Corp.1998-02-24
SYNTHES RESORBABLE FIXATION SYSTEM (K974554)Synthes (Usa)1998-02-24
PALFIQUE ESTELITE PASTE (K980051)Tokuyama America, Inc.1998-02-24
QUIKPAC II ONE STEP BENZODIAZEPINE TEST (K973326)Drial Consultants, Inc.1998-02-24
JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR (K974727)J.B.C and Co.1998-02-24
LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES (K974782)Mexpo Intl., Inc.1998-02-24
SILICONE BLOCKS (K974654)Specialty Surgical Products, Inc.1998-02-24
PHACO COMMANDER (K980085)Scieran Technologies, Inc.1998-02-24
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL (K974469)Mentor Corp.1998-02-24
MTA MATERIAL (K980332)Dentsply Intl.1998-02-24
MEDCOMP BIO-FLEX CS CATHETER (CS100) (K971925)Medical Components, Inc.1998-02-23
GREPAFLOXACIN, 5 MG, SENSI-DISC (K974578)Becton Dickinson Microbiology Systems1998-02-23
SURGICAL VASCULAR CLAMP (K973080)Walter Lorenz Surgical, Inc.1998-02-23
IRRIGATION BOTTLE (K973829)Automatic Liquid Packaging, Inc.1998-02-23
URINE SCREENING DEVICE (K972676)Combact Diagnostic Systems , Ltd.1998-02-23
MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM (K972207)Medcomp1998-02-23
4.0MM SIMPLER ONE THREADED DENTAL IMPLANT (K974401)Vancouver Implant Resources, Inc.1998-02-23
LOCATOR MODEL 4036 (K972814)Pacesetter, Inc.1998-02-23
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K974559)Scimed Life Systems, Inc.1998-02-23
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (K974816)Beckman Instruments, Inc.1998-02-20
PRESSURE GUARD SITE SELECT (A) (K973169)Span-America Medical Systems, Inc.1998-02-20
CARDIO-CARD MANAGEMENT SYSTEM II (K972795)Nasiff Assoc., Inc.1998-02-20
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE (K963758)Sorin Biomedical, Inc.1998-02-20
PRESSUREGUARD IV (K972486)Span-America Medical Systems, Inc.1998-02-20
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (K972904)Casco Standards1998-02-20
FACEPLATE ASSEMBLY (K974219)Finetone Hearing Instruments1998-02-20
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS (K963759)Sorin Biomedical, Inc.1998-02-20
VNUS CLOSURE SYSTEM (K974521)Vnus Medical Technologies, Inc.1998-02-20
ABUTMENT - COMPLETE (K974280)The Implant Center of the Palm Beaches1998-02-20
NONWOVEN DRESSING (K974823)Convatec, A Division of E.R. Squibb & Sons1998-02-20
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K972158)Princeton Regulatory Assoc.1998-02-20
CHROMOPHARE D 500, CHROMOPHARE D 530 (K974433)Berchtold Holding GmbH1998-02-20
SIMPLICARE THIN FILM WOUND DRESSINGS (K980209)Hollister, Inc.1998-02-20
ANATOM 1000 (A MINUS, A-) (K974455)Analogic Corp.1998-02-20
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER (K974389)Clinical Innovations, Inc.1998-02-19
MOISTAIR FLUID AIR TUBING SET (K974561)American Medical Devices, Inc.1998-02-19
MLS ELECTROMYOGRAPHIC PREAMPLIFIER (K974385)Motion Lab Systems, Inc.1998-02-19
FRIEDL GLIDING NAIL SYSTEM (K974409)Plus Orthopedics1998-02-19
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER (K974684)Scimed Life Systems, Inc.1998-02-19
MICHELSON ANTERIOR CERVICAL PLATE SYSTEM (K974435)Wrightmedicaltechnologyinc1998-02-19
LATIS GRAFT CLEANING CATHETER (K973465)Applied Medical Resources1998-02-19
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (K974775)Airtronic Services, Inc.1998-02-19
3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT (K974402)Vancouver Implant Resources, Inc.1998-02-19
VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET (K974215)Vetco, Inc.1998-02-19
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION (K974420)Hewlett-Packard Co.1998-02-19
4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT (K974404)Vancouver Implant Resources, Inc.1998-02-19
MOBIMED SYSTEM, (PEGASUS AND POLARIS) (K973318)Ortivus Us, Inc.1998-02-19
3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT (K974403)Vancouver Implant Resources, Inc.1998-02-19
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS (K973962)C.R. Bard, Inc.1998-02-19
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 (K974467)Aesculap-Meditec North America1998-02-19
BOSTON ADVANCE CLEANER (K974466)Polymer Technology Corp.1998-02-19
RUNCH INDUSTRIAL WHEELCHAIR (K980107)Runch Group USA, Inc.1998-02-19
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 (K974487)Asi Medical, Inc.1998-02-18
PULPDENT CAVITY VARNISH (K974398)Pulpdent Corp.1998-02-18
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM (K974573)Depuy, Inc.1998-02-18
STELLAR MODEL HS-04 (K973223)Stellar Medical Corp.1998-02-18
ACRI R NEEDLE (K980248)Gallini U.S., LLC1998-02-18
MANAN LIVER BIOPSY KIT (K980452)Medical Device Technologies, Inc.1998-02-18
JTECH ADJUSTER REFLEX GUN (K974376)J-Tech Medical, Inc.1998-02-18
RAPET CRP (K974429)Stanbio Laboratory1998-02-18
RELIEFBAND (K980333)Woodside Biomedical, Inc.1998-02-18
ULTRANEB (K974379)Bremed Italia, S.R.L.1998-02-18
BIOROC EZ SUTURE BONE FASTENER (K973381)Innovasive Devices, Inc.1998-02-18
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM (K980226)Medical Device Technologies, Inc.1998-02-18
ORTHOPLAN (K974406)Ortho-Graphics, Inc.1998-02-18
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM (K974537)Synthes (Usa)1998-02-18
PERCSCOPE MODEL 2600 (K974579)Clarus Medical Systems, Inc.1998-02-18
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER (K974049)Innovasive Devices, Inc.1998-02-18
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE (K973760)Avecor Cardiovascular, Inc.1998-02-18
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE (K971708)J & J Engineering, Inc.1998-02-18
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) (K971169)Cambridge Biotech Corp.1998-02-17
T.B.Q. RTU (K980369)STERIS Corporation1998-02-17
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 (K974505)Alfa Biotech (Uk) , Ltd.1998-02-17
WIELISA MPO ANCA TEST SYSTEM (K974166)Wieslab AB1998-02-17
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (K974564)Beckman Instruments, Inc.1998-02-17
WIELISA ANTI-GBM TEST SYSTEM (K974169)Wieslab AB1998-02-17
TRUE VISION, TRUE VISION II (K974542)Medical Dynamics, Inc.1998-02-17
ORGENTEC ANTI-MPO (P-ANCA) ELISA (K974701)American Laboratory Products Co., Ltd.1998-02-17
ALEX TA2 ERASER (K980131)Light Age, Inc.1998-02-17
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) (K974355)Ge Dec Medical Systems1998-02-17
INFUSION DYNAMICS POWER INFUSER (K974074)Infusion Dynamics, Inc.1998-02-17
WIELISA PR-3 ANCA TEST SYSTEM (K974167)Wieslab AB1998-02-17
RAPET RF (K974370)Stanbio Laboratory1998-02-17
REGANES RADIONUCLIDE SEED MAGAZINE (K972554)Avid N.I.T., Inc.1998-02-17
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET (K973483)Becton Dickinson Immunocytometry Systems1998-02-17
OBSERVER * CENTRAL STATION (K972498)Johnson & Johnson Medical, Inc.1998-02-17
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) (K971170)Cambridge Biotech Corp.1998-02-17
ORGENTEC ANTI-PR3 (C-ANCA) ELISA (K974702)American Laboratory Products Co., Ltd.1998-02-17
PANACRYL (K974299)ETHICON, Inc.1998-02-13
CK-NAC REAGENT (K974833)Intersect Systems, Inc.1998-02-13
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET (K970229)Arrow Intl., Inc.1998-02-13
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM (K973191)Pulmonx1998-02-13
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING (K974348)Laboratoires Urgo S.A.1998-02-13
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE (K974437)Lunar Corp.1998-02-13
RUSCH TRACHEOFIX-SET (K972423)Rusch Intl.1998-02-13
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (K974335)J-Lloyd Medical, Inc.1998-02-13
ADVANTX LCN, ADVANTX LCLP (K974367)GE Medical Systems1998-02-13
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS (K973459)Norland Corp.1998-02-13
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Every clearance here is in the API, with alerts when new ones post.