FDA 510(k) clearances — page 920

176,637 clearances on record, most recent first.

Clearances — page 920

91,901–92,000 of 176,637

K974455 — ANATOM 1000 (A MINUS, A-)Analogic Corp.·Product code JAK·1998-02-20
K974521 — VNUS CLOSURE SYSTEMVnus Medical Technologies, Inc.·Product code GEI·1998-02-20
K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229Beckman Instruments, Inc.·Product code LTJ·1998-02-20
K974823 — NONWOVEN DRESSINGConvatec, A Division of E.R. Squibb & Sons·Product code KMF·1998-02-20
K980209 — SIMPLICARE THIN FILM WOUND DRESSINGSHollister, Inc.·Product code MGP·1998-02-20
K973318 — MOBIMED SYSTEM, (PEGASUS AND POLARIS)Ortivus Us, Inc.·Product code MSX·1998-02-19
K973465 — LATIS GRAFT CLEANING CATHETERApplied Medical Resources·Product code DXE·1998-02-19
K973962 — BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONSC.R. Bard, Inc.·Product code DSP·1998-02-19
K974215 — VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SETVetco, Inc.·Product code LKY·1998-02-19
K974385 — MLS ELECTROMYOGRAPHIC PREAMPLIFIERMotion Lab Systems, Inc.·Product code IKN·1998-02-19
K974389 — KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.·Product code HFN·1998-02-19
K974402 — 3.25 MM SIMPLER ONE THREADED DENTAL IMPLANTVancouver Implant Resources, Inc.·Product code DZE·1998-02-19
K974403 — 3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANTVancouver Implant Resources, Inc.·Product code DZE·1998-02-19
K974404 — 4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANTVancouver Implant Resources, Inc.·Product code DZE·1998-02-19
K974409 — FRIEDL GLIDING NAIL SYSTEMPlus Orthopedics·Product code KTT·1998-02-19
K974420 — M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATIONHewlett-Packard Co.·Product code DSH·1998-02-19
K974435 — MICHELSON ANTERIOR CERVICAL PLATE SYSTEMWrightmedicaltechnologyinc·Product code KWQ·1998-02-19
K974466 — BOSTON ADVANCE CLEANERPolymer Technology Corp.·Product code MRC·1998-02-19
K974467 — AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08Aesculap-Meditec North America·Product code HJO·1998-02-19
K974561 — MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.·Product code KYG·1998-02-19
K974684 — SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERScimed Life Systems, Inc.·Product code DQY·1998-02-19
K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.·Product code FAP·1998-02-19
K980107 — RUNCH INDUSTRIAL WHEELCHAIRRunch Group USA, Inc.·Product code IOR·1998-02-19
K971708 — PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICEJ & J Engineering, Inc.·Product code HCC·1998-02-18
K973223 — STELLAR MODEL HS-04Stellar Medical Corp.·Product code IPF·1998-02-18
K973381 — BIOROC EZ SUTURE BONE FASTENERInnovasive Devices, Inc.·Product code MAI·1998-02-18
K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACEAvecor Cardiovascular, Inc.·Product code DTZ·1998-02-18
K974049 — INNOVASIVE LINX BT 10MM LIGAMENT FASTENERInnovasive Devices, Inc.·Product code MBI·1998-02-18
K974376 — JTECH ADJUSTER REFLEX GUNJ-Tech Medical, Inc.·Product code LXM·1998-02-18
K974379 — ULTRANEBBremed Italia, S.R.L.·Product code CAF·1998-02-18
K974398 — PULPDENT CAVITY VARNISHPulpdent Corp.·Product code LBH·1998-02-18
K974406 — ORTHOPLANOrtho-Graphics, Inc.·Product code HWT·1998-02-18
K974429 — RAPET CRPStanbio Laboratory·Product code DCN·1998-02-18
K974487 — SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020Asi Medical, Inc.·Product code EIA·1998-02-18
K974537 — SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEMSynthes (Usa)·Product code KTT·1998-02-18
K974573 — DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMDepuy, Inc.·Product code KWP·1998-02-18
K974579 — PERCSCOPE MODEL 2600Clarus Medical Systems, Inc.·Product code HRX·1998-02-18
K980226 — MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEMMedical Device Technologies, Inc.·Product code KNW·1998-02-18
K980248 — ACRI R NEEDLEGallini U.S., LLC·Product code KNW·1998-02-18
K980333 — RELIEFBANDWoodside Biomedical, Inc.·Product code GZJ·1998-02-18
K980452 — MANAN LIVER BIOPSY KITMedical Device Technologies, Inc.·Product code KNW·1998-02-18
K971169 — CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)Cambridge Biotech Corp.·Product code LSR·1998-02-17
K971170 — CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)Cambridge Biotech Corp.·Product code LSR·1998-02-17
K972498 — OBSERVER * CENTRAL STATIONJohnson & Johnson Medical, Inc.·Product code DSI·1998-02-17
K972554 — REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.·Product code IWJ·1998-02-17
K973483 — FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETBecton Dickinson Immunocytometry Systems·Product code GKZ·1998-02-17
K974074 — INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.·Product code KZD·1998-02-17
K974166 — WIELISA MPO ANCA TEST SYSTEMWieslab AB·Product code MOB·1998-02-17
K974167 — WIELISA PR-3 ANCA TEST SYSTEMWieslab AB·Product code MOB·1998-02-17
K974169 — WIELISA ANTI-GBM TEST SYSTEMWieslab AB·Product code DBL·1998-02-17
K974355 — INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)Ge Dec Medical Systems·Product code OWB·1998-02-17
K974370 — RAPET RFStanbio Laboratory·Product code DHR·1998-02-17
K974505 — AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501Alfa Biotech (Uk) , Ltd.·Product code DBF·1998-02-17
K974542 — TRUE VISION, TRUE VISION IIMedical Dynamics, Inc.·Product code EIA·1998-02-17
K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENTBeckman Instruments, Inc.·Product code DEB·1998-02-17
K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISAAmerican Laboratory Products Co., Ltd.·Product code MOB·1998-02-17
K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISAAmerican Laboratory Products Co., Ltd.·Product code MOB·1998-02-17
K980131 — ALEX TA2 ERASERLight Age, Inc.·Product code GEX·1998-02-17
K980369 — T.B.Q. RTUSTERIS Corporation·Product code LRJ·1998-02-17
K970229 — ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETArrow Intl., Inc.·Product code DYB·1998-02-13
K972423 — RUSCH TRACHEOFIX-SETRusch Intl.·Product code JOH·1998-02-13
K973191 — THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEMPulmonx·Product code BTR·1998-02-13
K973395 — EPISCREEN ORAL SPECIMEN COLLECTION DEVICEEpitope, Inc.·Product code PJD·1998-02-13
K973459 — NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERSNorland Corp.·Product code KGI·1998-02-13
K973750 — STC CANNABINOIDS MICRO-PLATE EIAOraSure Technologies, Inc.·Product code LDJ·1998-02-13
K974297 — GALILEO DISPOSABLE HYSTEROSCOPESNetoptix Corp.·Product code HIH·1998-02-13
K974299 — PANACRYLETHICON, Inc.·Product code GAM·1998-02-13
K974307 — RTR-2000/RTR-4000Terarecon,Inc.·Product code JAK·1998-02-13
K974316 — HYDROFERA FEMORAL WICKHydrofera, LLC·Product code EFQ·1998-02-13
K974318 — HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMBHealthcare Service and Supply·Product code JOW·1998-02-13
K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.J-Lloyd Medical, Inc.·Product code DXE·1998-02-13
K974336 — CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.J-Lloyd Medical, Inc.·Product code GCJ·1998-02-13
K974345 — MITEK KNOTLESS ANCHORMitek Products·Product code MBI·1998-02-13
K974348 — ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSINGLaboratoires Urgo S.A.·Product code FRO·1998-02-13
K974367 — ADVANTX LCN, ADVANTX LCLPGE Medical Systems·Product code IZI·1998-02-13
K974437 — EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARELunar Corp.·Product code KGI·1998-02-13
K974444 — NUMASTATIONNuma, Inc.·Product code KPS·1998-02-13
K974779 — ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZERAbbott Laboratories·Product code JJE·1998-02-13
K974833 — CK-NAC REAGENTIntersect Systems, Inc.·Product code CGS·1998-02-13
K980220 — IISYS PACS SYSTEMSterling Diagnostic Imaging, Inc.·Product code LMD·1998-02-13
K972512 — SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANELBoston Scientific Scimed, Inc.·Product code LIT·1998-02-12
K974029 — ACS TOBRAMYCINChiron Diagnostics Corp.·Product code LCR·1998-02-12
K974289 — EPI-UNION PLATING SYSTEMHowmedica, Inc.·Product code HRS·1998-02-12
K974349 — OHMEDA-OHIO CARE PLUS INCUBATOROhmeda Medical·Product code FMZ·1998-02-12
K974362 — PASCO MIC AND MIC/ID PANELSPasco Laboratories, Inc.·Product code JWY·1998-02-12
K974531 — SNORE-EZZERSnore - Ezzer·Product code LRK·1998-02-12
K974606 — RANDOX MAGNESIUMRandox Laboratories, Ltd.·Product code JGJ·1998-02-12
K974645 — FEMASSIST FLEXIBLEInsight Medical Corp.·Product code MNG·1998-02-12
K974651 — ABBOTT AXSYM SYSTEMAbbott Laboratories·Product code JJE·1998-02-12
K974712 — QUIKSTRIP ONE STEP BARBITURATE TESTSyntron Bioresearch, Inc.·Product code DIS·1998-02-12
K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)Kawasumi Laboratories Co., Ltd.·Product code LJT·1998-02-12
K974874 — BILIRUBIN-SL (TOTAL) ASSAYDiagnostic Chemicals, Ltd. (Usa)·Product code CIG·1998-02-12
K974894 — KROMATICA COLOR CHANGING ALGINATEMatech, Inc.·Product code ELW·1998-02-12
K980069 — VANISHPOINT SYRINGERetractable Technologies, Inc.·Product code MEG·1998-02-12
K980178 — OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRYBionostics, Inc.·Product code JJY·1998-02-12
K980180 — 2700 SAMPLE MANAGERWaters Corporation·Product code JQW·1998-02-12
K980205 — SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TESTSan Diego Biotech·Product code JHI·1998-02-12
K980316 — ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30Diagnostic Chemicals , Ltd.·Product code CJE·1998-02-12
K970358 — ENSEMBLE CENTRAL STATION MONITORMennen Medical, Inc.·Product code DSI·1998-02-11
K971206 — MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATINGHowmedica Corp.·Product code LPH·1998-02-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.