FDA 510(k) clearances — page 1378

176,637 clearances on record, most recent first.

Clearances — page 1378

137,701–137,800 of 176,637

K880813 — SELF-RETAINING SOFT TISSUE RETRACTORT. Korossurgical Instruments Corp.·Product code GAD·1988-03-11
K874635 — OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGESOsteonics Corp.·Product code JWH·1988-03-10
K875076 — FLORIDA PROBEFlorida Probe Corp.·Product code EIX·1988-03-10
K875238 — SIEMENS NEUROTON 826 AND 827Elmed, Inc.·Product code IPF·1988-03-10
K875313 — PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYSTBisco, Inc.·Product code EBF·1988-03-10
K871744 — CONTATTO CONDOMSRazi Corp.·Product code HIS·1988-03-09
K872984 — KETAC-CONDITIONEREspe GmbH (Us)·Product code EMA·1988-03-09
K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBINGDhd Medical Products Div. Diemolding Corp.·Product code BXR·1988-03-09
K873807 — AUTOTRANSFUSION APPARATUSBiodynamics Corp.·Product code CAC·1988-03-09
K875047 — COULTER CLONE T11 MONOCLONAL ANTIBODYCoulter Electronics, Inc.·Product code GKZ·1988-03-09
K875089 — HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARINHemotec, Inc.·Product code JPA·1988-03-09
K875228 — PERMADYNE ADHESIVEEspe GmbH (Us)·Product code EBH·1988-03-09
K875257 — IMPREGUM F ADHESIVEEspe GmbH (Us)·Product code EBH·1988-03-09
K875383 — LAKE CATHETER CARE KITS (MODIFICATION)Lake Medical Products, Inc.·Product code KOD·1988-03-09
K880082 — MEMORYMATE HEARING AID MODEL 82003M Company·Product code ESD·1988-03-09
K880169 — CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATIONCemax, Inc.·Product code LLZ·1988-03-09
K880179 — BEAVERS' DENTAL DIAMOND INSTRUMENTSBeavers Dental, Div. Sybron Canada, Ltd.·Product code DZP·1988-03-09
K880184 — VIBRASOUND IN-THE-EAR HEARING AIDVibrasound Research Corp.·Product code ESD·1988-03-09
K880225 — MAGIC EAR MODEL CI IN-THE-EAR HEARING AIDAudiotone, Inc.·Product code ESD·1988-03-09
K880283 — PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTSPaceart, Inc.·Product code DXH·1988-03-09
K880518 — MOBILE C-ARM OMNI 325Fischer Imaging Corp.·Product code OXO·1988-03-09
K880614 — SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBEShiley, Inc.·Product code BTO·1988-03-09
K880635 — IN THE EAR HEARING AIDTallahassee Hearing Aid Center·Product code ESD·1988-03-09
K880664 — MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)Mortara Instrument, Inc.·Product code DSI·1988-03-09
K880683 — KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUITKing Systems Corp.·Product code CAI·1988-03-09
K875082 — O.P.C. INTRAVASCULAR CATHETERTaut, Inc.·Product code FOZ·1988-03-08
K875112 — MENTOR B-VAT(TM) II VIDEO TESTERMentor O & O, Inc.·Product code HOX·1988-03-08
K880024 — TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUSTambrands, Inc.·Product code HIL·1988-03-08
K880114 — NUTRIENT BROTHHardy Media·Product code JSG·1988-03-08
K880115 — NUTRIENT GELATINHardy Media·Product code JSF·1988-03-08
K880464 — DYNATRON IIDynatronics Laser Corp.·Product code LBB·1988-03-08
K873739 — ACRYLIC IMPRESSION TRAY MATERIALSE&D Dental Manufacturing Co.·Product code EBH·1988-03-07
K873853 — DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0Advanced Surgical Products, Inc.·Product code HMX·1988-03-07
K873896 — SIMED S-100 PULSE OXIMETERSimed·Product code DQA·1988-03-07
K874319 — MONITOR, ELECTROGRAPHICMedac, Inc.·Product code DRT·1988-03-07
K874383 — MENTOR PLUS (CONDOM)Arcon Corp.·Product code HIS·1988-03-07
K874542 — TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPESToray Industries (America), Inc.·Product code DQX·1988-03-07
K874594 — TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560Clinical Sciences, Inc.·Product code LGD·1988-03-07
K874676 — INTERFERENCE SCREWConcept, Inc.·Product code HWC·1988-03-07
K875109 — DETECTADOT SYSTEM 2000 TOXO IGG TESTGull Laboratories, Inc.·Product code LGD·1988-03-07
K875195 — OPHTHALMIC LIGHT PIPE PICKTrek Medical Products, Inc.·Product code FST·1988-03-07
K875298 — 502-US PULSE OXIMETERCriticare Systems, Inc.·Product code DQA·1988-03-07
K880033 — DEGUSTARDegussa Dental, Inc.·Product code EJT·1988-03-07
K880036 — BIOMA 5000E.B.S., Inc.·Product code DRG·1988-03-07
K880062 — C-MATE #CMU 1001O.R. Specialties, Inc.·Product code HQC·1988-03-07
K880068 — EFFERVESCENT DENTURE CLEANSERPerrigo Co.·Product code EFT·1988-03-07
K880127 — POTATO DEXTROSE AGARHardy Media·Product code KZI·1988-03-07
K880224 — MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AIDAudiotone, Inc.·Product code ESD·1988-03-07
K880349 — MODEL 759 CUSTOM IN-THE-EAR HEARING AIDBernafon, Inc.·Product code ESD·1988-03-07
K880551 — MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEADIntermedics, Inc.·Product code DTB·1988-03-07
K872996 — NATURAL-TOUCH (TM) SURGEON'S GLOVEHands-On Packaging , Ltd.·Product code KGO·1988-03-04
K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSMinnesota Laser Corp.·Product code LLO·1988-03-04
K874825 — DISPOSABLE CAUTERIESMidsouth Industries, Inc.·Product code GEI·1988-03-04
K875225 — UMBILICAL ARTERY OXYGEN SENSOROhmeda Medical·Product code CCE·1988-03-04
K875227 — STERILE EMPTY VIALSAllertech, Inc.·Product code LDH·1988-03-04
K875290 — LUMBAR IMPACTION SETT. Korossurgical Instruments Corp.·Product code KWP·1988-03-04
K880035 — DAEWOO LATEX SURGICAL GLOVECalifornia Ent.·Product code KGO·1988-03-04
K880048 — BLADE, SURGICAL PREP RAZOR STRAIGHTCrescent Corp.·Product code LDQ·1988-03-04
K880150 — PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEMDyonics, Inc.·Product code HWE·1988-03-04
K880161 — ACKRAD PEDIATRIC C.P.A.P. SYSTEMAckrad Laboratories·Product code BYE·1988-03-04
K880211 — TSRH H/M HOOK HOLDERWarsaw Orthopedic, Inc.·Product code KWP·1988-03-04
K880212 — TSRH H/M HOOK HOLDER W/ROD MOVERWarsaw Orthopedic, Inc.·Product code KWP·1988-03-04
K880216 — MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.Directed Energy, Inc.·Product code GEX·1988-03-04
K880304 — INSPIRON NEBULO BASIC EXTERNAL HEATERIntertech Resources, Inc.·Product code CAF·1988-03-04
K880413 — PATELLAR TENDON GRAFT GUIDEConcept, Inc.·Product code LXH·1988-03-04
K880450 — RESUSCI PATIENT FACE SHIELDLaerdal Medical Corp.·Product code BTM·1988-03-04
K880571 — CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEMCatheter Technology Corp.·Product code LJT·1988-03-04
K880613 — ACCO(R) FACE MASKAbsorbent Cotton Co., Inc.·Product code FXX·1988-03-04
K880649 — TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERINGLabeltape Meditect, Inc.·Product code GXY·1988-03-04
K872482 — GAMBRO-ENGSTROM ERICA IV RESPIRATORGambro, Inc.·Product code CBK·1988-03-03
K874481 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290Y·Product code LDR·1988-03-03
K874833 — ARC ADAPTER ASSEMBLYMedical Equipment Development Co., Inc.·Product code HAW·1988-03-03
K874846 — GLUCOSE (HEXOKINASE)Tech-Co, Inc.·Product code CFR·1988-03-03
K874916 — TECHNICON CHEM 1(TM) SYSTEMTechnicon Instruments Corp.·Product code LDR·1988-03-03
K874946 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60Shimadzu Precision Instruments, Inc.·Product code IZO·1988-03-03
K875038 — MENTOR UNISTENT URETERAL STENT SETMentor Corp.·Product code FAD·1988-03-03
K875098 — CIBA CORNING MODEL 644Ciba Corning Diagnostics Corp.·Product code JXR·1988-03-03
K875213 — SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICETitan Medical, Inc.·Product code LJT·1988-03-03
K880232 — NH REPLACEMENT GASTROSTOMY KITBiosearch Medical Products, Inc.·Product code KNT·1988-03-03
K880240 — INSTANT EOSIN-ALCOHOLICShandon, Inc.·Product code HYB·1988-03-03
K880276 — AST (SGOT) REAGENT SETTech-Neal Scientific, Inc.·Product code CIT·1988-03-03
K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASESerono Diagnostics, Inc.·Product code CDP·1988-03-03
K880460 — TARGET STREP AV-Tech, Inc.·Product code GTZ·1988-03-03
K880494 — LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)Bio-Rad·Product code JJY·1988-03-03
K880529 — CEILING MOUNTED TILTING TABLE TANGENT IIIFischer Imaging Corp.·Product code IXR·1988-03-03
K880530 — CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEXFischer Imaging Corp.·Product code IYB·1988-03-03
K880680 — KING SYSTEMS, BREATHING BAGKing Systems Corp.·Product code BTC·1988-03-03
K880716 — SLIDE CULTURE PLATE-POTATO FLAKE AGARRemel Co.·Product code JSJ·1988-03-03
K880717 — SLIDE CULTURE PLATE-POTATO DEXTROSE AGARRemel Co.·Product code JSJ·1988-03-03
K871313 — ULTRA-FRESH DEODORANTMentor Corp.·Product code GDS·1988-03-02
K871555 — RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.General Electric Co.·Product code DXK·1988-03-02
K872588 — CLEARFIL PHOTO POSTERIORKuraray Co.·Product code EBF·1988-03-02
K873521 — BRONCHODILATOR TEE - 9056 SERIESBoehringer Laboratories·Product code CAF·1988-03-02
K873989 — DOPPLEX ULTRASONIC DOPPLER SYSTEMUltramed, Inc.·Product code JOP·1988-03-02
K874400 — NON-ROTATING GOLD CYLINDER AND SCREWImplant Innovations International, Inc.·Product code DZE·1988-03-02
K874674 — AIK-100 ANESTHESIA INDUCTION KIT/TRAYMedical Repackers Co.·Product code CAZ·1988-03-02
K875119 — BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBEAdvanced Diagnostic Medical Systems, Inc.·Product code FCI·1988-03-02
K875126 — MIC (SPECIFIC LINE) INSERTION KITMedical Innovations Corp.·Product code KNT·1988-03-02
K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONICF.M. Wiest USA, Inc.·Product code HES·1988-03-02
K875166 — PHARMASEAL STERILE UMBILICAL CORD CLAMPBaxter Healthcare Corp·Product code HWI·1988-03-02

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