FDA 510(k) clearances — page 659
clearances on record, most recent first.
Clearances — page 659
65,801–65,900 of 176,637- K051429 — CLARIS NON-STICK BIPOLAR FORCEPS
- K051590 — T2 ANKLE ARTHRODESIS NAIL
- K051610 — HANS HERMANN LAPAROSCOPES AND ACCESSORIES
- K051767 — LTV 1000 VENTILATOR
- K042125 — AFT
- K042579 — BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
- K042726 — QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
- K050635 — ALLFIM IMPLANT SYSTEMS
- K050687 — AXIOM EPS8000
- K050808 — CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
- K050857 — BIB PTA BALLOON CATHETER
- K051224 — BOSWORTH SEAL
- K051343 — MINI GHOST PTA CATHETER, MODEL 507
- K051375 — VITAL SIGNS MONITOR
- K051527 — SPI EASY TEMPORARY CAP
- K051739 — POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.
- K051773 — MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
- K051780 — JETLITE 5000
- K050436 — MS 9/5 HEMATOLOGY ANALYZER
- K050461 — XIA 4.5 SPINAL SYSTEM
- K050463 — CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
- K050651 — MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
- K050681 — OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
- K050979 — S4 SPINAL SYSTEM
- K051393 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
- K051454 — ALEUTIAN SPACER SYSTEM
- K051478 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN
- K051488 — MEDICINELODGE ZIPKNOT
- K051506 — MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
- K051509 — ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
- K051516 — TRABECULAR METAL REVISION SHELL LINERS
- K051581 — SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
- K051600 — SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
- K051631 — EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
- K051681 — DERMILLUME RED, MODEL HR1000
- K051756 — MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
- K051845 — THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM
- K051867 — GRANDIO
- K051868 — GRANDIO FLOW
- K051921 — THE EDGE DETECTOR, MODEL 1118
- K051942 — MALIBU SPINAL SYSTEM
- K050542 — MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
- K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
- K051141 — WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
- K051150 — TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
- K051310 — PLC SCREW
- K051778 — NITRILE POWDERED EXAMINATION GLOVES (BLUE)
- K051919 — MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
- K043055 — TERRAQUANT MQ2000 LASER THERAPY DEVICE
- K050570 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM
- K050862 — 3TP WORKSPACE
- K050891 — TOX A/B QUICK CHEK
- K051019 — SAFETY NEEDLE
- K051194 — BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669
- K051261 — DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE
- K051350 — SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
- K051457 — SENTINEL PLASMAPROTEINS CAL 3X
- K051687 — ELECSYS PRECICONTROL UNIVERSAL
- K051720 — SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
- K051743 — R2 BREAST IMAGING WORKSTATION
- K051746 — ELEKTA ESARTE FRAME SYSTEM
- K051790 — 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
- K033028 — ANEFIN, MODEL 100
- K040283 — BIOPAD
- K050574 — AFINION HBALC
- K051180 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051249 — ZIROX
- K051333 — NITRILE EXAMINATION GLOVES, POWDER FREE
- K051365 — COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
- K051443 — CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
- K051627 — VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT
- K051652 — ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT
- K051662 — VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
- K051751 — EQUA-PULL SAFETY RELEASE MODULE
- K041849 — TURBO-FLO PICC
- K043322 — MIRAMATIC SAFE SYRINGE SYSTEM
- K050391 — PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
- K051053 — OSCAR, MODEL OE3000DB
- K051215 — CELL-DYN SAPPHIRE SYSTEM
- K051256 — SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
- K051410 — ACUMED RIB CONGRIENT BONE PLATE SYSTEM
- K051538 — AVANTICARE, MODEL SA4022
- K051674 — CD HORIZON SPINAL SYSTEM
- K051797 — FUTURE WASH/YPS
- K042648 — REPROCESSED COLD BIOPSY FORCEPS
- K050136 — REPROCESSED HOT BIOPSY FORCEPS
- K051229 — PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
- K051523 — REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION
- K051528 — MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE
- K051628 — INFINITY MONITORS WITH SCIO MODIFICATIONS
- K051664 — SCAN300FP / RETROPAN (VDC)
- K051728 — MODIFICATION TO SHOULDER FIXATION SYSTEM
- K051784 — OSTEOVATION CMF BONE VOID FILLER
- K051837 — MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100
- K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
- K042583 — CALC-I-OSS
- K043032 — DEALIGHT IPL
- K043528 — SPIROTEL
- K050210 — DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
- K050417 — ELITE IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.