FDA 510(k) clearances — page 1307

176,637 clearances on record, most recent first.

Clearances — page 1307

130,601–130,700 of 176,637

K894761 — TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KITHybritech, Inc.·Product code CGJ·1989-09-13
K894787 — MEL-PAK GENERAL DRUG DELIVERY SYSTEM KITNew York Blood Center, Inc.·Product code FPA·1989-09-13
K894975 — IMMUNODOT INFECTIOUS MONONUCLEOSIS TESTGeneral Biometrics, Inc.·Product code KTN·1989-09-13
K895079 — ACE BEADED K-WIRES ACE OLIVE WIRESBuckman Co., Inc.·Product code HTY·1989-09-13
K884692 — THE SAFEGARD PERSONAL PROTECTION KITThe Safegard Protection Corp.·Product code HIS·1989-09-12
K890400 — MODIFIED URINARY CATHETER INTRODUCER (UCI)Go Medical Industries Pty. , Ltd.·Product code KOD·1989-09-12
K890959 — GUIDEWIREGuidewire Technologies, Inc.·Product code DQX·1989-09-12
K891231 — OPTIMA MPT AND SPT PACEMAKERSTelectronics, Inc.·Product code DXY·1989-09-12
K891575 — COMPAT ENTERAL FEED PUMP 199235 & 199240Sandoz Nutrition·Product code LZH·1989-09-12
K891582 — MODIFIED OSTEOANALYZER (# SPSHA110/220)Osteon, Inc.·Product code KGI·1989-09-12
K892035 — PATIENT EXAMINATION GLOVE (LATEX)Fine Spring Ent. Co., Ltd.·Product code LYY·1989-09-12
K892386 — DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250AToshiba America Medical Systems, In.C·Product code IYO·1989-09-12
K892501 — WRIGHT MEDICAL FETASAFEWright Medical Corp.·Product code HGM·1989-09-12
K893235 — LATEX EXAMINATION GLOVESQuingdao Latex Factory·Product code LYY·1989-09-12
K893339 — LATEX EXAMINATION GLOVESKenmark Industrial Co., Ltd.·Product code LYY·1989-09-12
K893796 — DISPOSABLE VINYL (PVC) EXAMINATION GLOVESAnmei Plastic & Rubber Products Co. , Ltd.·Product code LYZ·1989-09-12
K894018 — RELIANCE(R) 6200 EXAMINATION CHAIRReliance Medical Products, Inc.·Product code HME·1989-09-12
K894054 — 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.·Product code IYN·1989-09-12
K894163 — PHASE 2 TRANSCRANIAL PROBEBiosound, Inc.·Product code IYN·1989-09-12
K894177 — NEEDLE*LESS DRUG VIAL ADAPTERBaxter Healthcare Corp·Product code FMF·1989-09-12
K894186 — SURGIFLEX LASER CONTACT TIPSCabot Medical Corp.·Product code GEX·1989-09-12
K894217 — SYRINGE TIP ADAPTORAcacia, Inc.·Product code FMF·1989-09-12
K894330 — DAIG VESSEL DILATORDaig Corp.·Product code DRE·1989-09-12
K894335 — MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STRMidmark Corp.·Product code FMF·1989-09-12
K894383 — DISPOSABLE SHOE COVERAmerican Threshold Industries, Inc.·Product code FXP·1989-09-12
K894479 — 30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SEBennett X-Ray Corp.·Product code IZO·1989-09-12
K894516 — VISOSHIELD(TM), SURGICAL EYE PROTECTORPolamedco, Inc.·Product code FXX·1989-09-12
K894682 — USCI UNCOATED GUIDING CATHETERSC.R. Bard, Inc.·Product code DQY·1989-09-12
K894842 — IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADMImed Corp.·Product code FPA·1989-09-12
K894905 — FACE PROTECTION PAK(TM)Protech Products·Product code FXX·1989-09-12
K894972 — UNICARE LATEX EXAMINATION GLOVESPt. Indorub Nusaraya·Product code LYY·1989-09-12
K894974 — MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEMResonex, Inc.·Product code LNH·1989-09-12
K894979 — LATEX PATIENT EXAMINATION GLOVESTower Rubber Industries Sdn. Bhd.·Product code LYY·1989-09-12
K894995 — LATEX PATIENT EXAMINATION GLOVESOrient Commercial Co., Ltd.·Product code LYY·1989-09-12
K895172 — KRONNER SACRAL PIN GUIDEKronner Medical·Product code LXH·1989-09-12
K895173 — SKELETAL FIXATION PINKronner Medical·Product code JDW·1989-09-12
K895217 — CORTICAL SCREWOrthopedic Systems, Inc.·Product code HWC·1989-09-12
K895218 — CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MMOrthopedic Systems, Inc.·Product code HWC·1989-09-12
K895219 — CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MMOrthopedic Systems, Inc.·Product code HWC·1989-09-12
K890178 — WHEELCHAIR STUMP SUPPORTGerber Chair Mates, Inc.·Product code KNN·1989-09-11
K891509 — PATIENT EXAMINATION GLOVES (LATEX)Delaware Industries, Inc.·Product code LYY·1989-09-11
K892182 — PATIENT EXAM GLOVES (MFG. SHANGHAI - CHANGZHENG)Grand Monde Trading Co., Inc.·Product code LYY·1989-09-11
K892620 — PATIENT EXAMINATION GLOVES (LATEX)Permark Sdn. Bhd.·Product code LYY·1989-09-11
K892623 — PATIENT EXAMINATION GLOVES (LATEX)Globe Ent., Inc.·Product code LYY·1989-09-11
K892684 — PATIENT EXAMINATION GLOVES (LATEX)Baldur Systems Corp.·Product code LYY·1989-09-11
K893095 — STERILE PATIENT EXAMINATION GLOVES (LATEX)Asia Way Trading, Inc.·Product code LYY·1989-09-11
K893100 — VINYL EXAMINATION GLOVESTong Shiung Plastics Industry·Product code LYZ·1989-09-11
K893159 — GLOBE PATIENT EXAMINATION GLOVESLucky and Happy, Inc.·Product code LYY·1989-09-11
K893279 — LATEX EXAMINATION GLOVESSafetytech Sdn. Bhd.·Product code LYY·1989-09-11
K893280 — PROFECT EXAMINATION GLOVESShanghai Latex Factory·Product code LYY·1989-09-11
K893294 — POWDER FREE VINYL (PVC) EXAM GLOVESKing Handy Five Corp.·Product code LYZ·1989-09-11
K893833 — AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLERAcoustic Imaging·Product code IYN·1989-09-11
K893872 — P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENTJohnson & Johnson Professionals, Inc.·Product code KWY·1989-09-11
K893932 — LATEX EXAMINATION GLOVESNgai Hing Latex Gloves Mfg. Co.·Product code LYY·1989-09-11
K893968 — VKG 2000 VIDEO KERATOMETERTechnitex, Inc.·Product code HJA·1989-09-11
K894025 — VINYL EXAMINATION GLOVES (NON-STERILE)Good Glove Corp.·Product code LYZ·1989-09-11
K894124 — OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWSOsteonics Corp.·Product code HWC·1989-09-11
K894398 — STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDEPymah Corp.·Product code FRC·1989-09-11
K894399 — STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.Pymah Corp.·Product code FRC·1989-09-11
K894427 — DISPOSABLE IV INDUCTION COVERCentral Plastic, Inc.·Product code FMK·1989-09-11
K894770 — PERSONAL BACK WITH FIP KITCanadian Posture and Seating Centre, Inc.·Product code KNN·1989-09-11
K894927 — SURGI SQUEEZEthox Corp.·Product code KZD·1989-09-11
K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPEMentor O & O, Inc.·Product code HLI·1989-09-11
K895015 — ARTROMOT(TM) CPM DEVICESBuckman Co., Inc.·Product code BXB·1989-09-11
K895016 — MODEL #510/515 GENERAL TRANSPORT STRETCHERMidmark Corp.·Product code INW·1989-09-11
K895107 — ACE ORTHOPAEDIC WASHERSBuckman Co., Inc.·Product code HTN·1989-09-11
K895121 — INTERMEDICS POWER BROACH IMPACTORIntermedics Orthopedics·Product code HSZ·1989-09-11
K895165 — ZIGGY MEDICHAIRLaszlo Corp.·Product code INM·1989-09-11
K875317 — ELECTRICAL MUSCLE STIMULATOR MODEL MYOAIDElectro Therapeutic Devices, Inc.·Product code IPF·1989-09-08
K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)Primrose Medical, Inc.·Product code ODD·1989-09-08
K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORSPrimrose Medical, Inc.·Product code KNQ·1989-09-08
K885168 — RUBENSTEIN URETERAL STONE FRAGMENT BRUSHBoston Scientific Corp·Product code FGO·1989-09-08
K892108 — STERILE NATURAL LATEX SURGICAL GLOVESRuhn Chang Industrial Co., Ltd.·Product code KGO·1989-09-08
K892191 — PATIENT EXAMINATION GLOVES (VINYL)Hsing YI Plastics Processing Co, Ltd.·Product code LYZ·1989-09-08
K893050 — PATIENT EXAMINATION GLOVESParatex Product Co., Ltd.·Product code LYY·1989-09-08
K893263 — LATEX EXAMINATION GLOVESRegent Group Co., Ltd.·Product code LYY·1989-09-08
K893553 — BIPOLAR ELECTROSURGICAL SNAREEverest Medical Corp.·Product code FDI·1989-09-08
K893721 — LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENTLori Medical Laboratories, Inc.·Product code ESD·1989-09-08
K893722 — LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENTLori Medical Laboratories, Inc.·Product code ESD·1989-09-08
K893723 — LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENTLori Medical Laboratories, Inc.·Product code ESD·1989-09-08
K893836 — EPLAB (ELECTROCARDIOGRAPHIC MONITOR)Quinton Electrophysiology Corp.·Product code DSH·1989-09-08
K893965 — PROLONG INTRAVASCULAR CATHETERBaxter Healthcare Corp·Product code FOZ·1989-09-08
K893992 — NOETIX, BIOPSY NEEDLENoetix, Inc.·Product code KNW·1989-09-08
K894049 — IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KITPantex, Div. Bio-Analysis, Inc.·Product code JLS·1989-09-08
K894419 — GASTRO ENTEROLOGICAL BIOPTOMESymbiosis Corp.·Product code KNW·1989-09-08
K894592 — LAMANO DIRECTORSMarlo Surgical Technology·Product code GCM·1989-09-08
K894612 — INTERTECH NEWBORN HYPERINFLATION BAG SYSTEMIntertech Resources, Inc.·Product code NHK·1989-09-08
K894690 — CPAP MASKDevilbiss Health Care, Inc.·Product code BYE·1989-09-08
K894788 — DMI SERIES 90 EXAMINATION TABLEM.D. Intl., Inc.·Product code KMN·1989-09-08
K894829 — CEFIXIME 5 MCG SENSITIVITY DISKSDifco Laboratories, Inc.·Product code JTN·1989-09-08
K894845 — (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEMeridian Diagnostics, Inc.·Product code GMD·1989-09-08
K884970 — PINSETSafety Diagnostics, Inc.·Product code JKA·1989-09-07
K890087 — ACUDATA INDICATENS MODEL 5MAcudata Software·Product code GZJ·1989-09-07
K892622 — PATIENT EXAMINATION GLOVES (LATEX)Latexon Co., Ltd.·Product code LYY·1989-09-07
K893390 — MODIFIED PRISTINE CULTURE CATHETERHml Medical, Inc.·Product code KOD·1989-09-07
K893811 — SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEMSakura Finetek U.S.A., Inc.·Product code JQW·1989-09-07
K894059 — ISOLIGHTEurodent, Inc.·Product code EAZ·1989-09-07
K894060 — ESSE QUATTRO/ESSE UNOEurodent, Inc.·Product code KLC·1989-09-07
K894063 — TRIGLYCERIDE (GPO) TRINDER REAGENTSigma Diagnostics, Inc.·Product code JGY·1989-09-07
K894170 — DEVON DISPOSABLE HEAD POSITIONER COVERDevon Industries, Inc.·Product code KME·1989-09-07

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