FDA 510(k) clearances — page 583
clearances on record, most recent first.
Clearances — page 583
58,201–58,300 of 176,542- K072599 — PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
- K072605 — MALIBU SPINAL SYSTEM
- K072631 — JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
- K072642 — BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
- K072697 — 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
- K072764 — KLS MARTIN XTERNAL FIXATOR
- K072976 — MODEL 250CX SERIES MATERNAL/FETAL MONITOR
- K072980 — NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
- K073127 — BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
- K073175 — JOURNEY UNICONDYLAR FEMORAL IMPLANT
- K073193 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
- K073259 — XIDF-100A/B1 IMAGE PROCESSOR
- K073304 — CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
- K073325 — LEGION POROUS PRIMARY
- K073397 — MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)
- K073398 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)
- K073400 — VARICATH PERIPHERAL INFUSION CATHETER
- K073448 — MEDICAL DISPLAY, MD205MG
- K073456 — T-QUEST SYSTEM
- K073518 — FLASHLITE REBEL*
- K070873 — AMSURE BLADDER IRRIGATION SET
- K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
- K071616 — ARC SURGICAL BIOTRAK PIN SYSTEM
- K071691 — DUAL SHOT ALPHA
- K071781 — PF4 IGG
- K072078 — QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
- K072168 — OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
- K072466 — STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
- K072478 — BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD
- K072547 — JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
- K072592 — PERFORMAX TOTAL FACE MASK
- K072707 — PATIENT CONTOURED MESH-PEEK (PCM-P)
- K072756 — NON-IV ADAPTER FOR INFANT NG TUBE
- K072810 — PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
- K072951 — PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
- K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
- K072997 — NEOMED URINARY CATHETER
- K073020 — ECLIPSE TREATMENT PLANNING SYSTEM
- K073117 — DENTIN DESENSITIZER AGENT
- K073196 — MASTER-VU
- K073205 — NIO 5MP, MODEL MDNG-5121
- K073220 — THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT
- K073340 — COLOR LCD MONITOR, FLEXSCAN MX300W
- K073350 — SCANORA 3D
- K073360 — PROPLATE
- K073408 — GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
- K073423 — MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
- K070060 — WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
- K070356 — MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
- K071537 — STERRAD 100NX TEST PACK
- K071930 — ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
- K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
- K072146 — EMS PIEZON MASTER SURGERY
- K072180 — VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
- K072271 — STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
- K072537 — CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
- K072588 — PERFORMAX SE TOTAL FACE MASK
- K072676 — ACUSON X300 ULTRASOUND SYSTEM
- K072758 — SYNTHES (USA) 2.0MM TITANIUM T-PLATE
- K072796 — MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
- K072995 — TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER
- K073001 — IDRIVES, IDRIVEC, IDRIVEF
- K073045 — SAPPHIRE CERAMIC BRACKET
- K073297 — GE LOGIQ P6
- K073373 — SYNGO VOLUME PERFUSION-CT BODY
- K071679 — METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
- K071876 — CROSS.BONE
- K073186 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
- K063243 — VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
- K070722 — PLASMAIR, MODEL T2006
- K071353 — FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
- K071400 — SMARTSITE STOPCOCK
- K071613 — AMIGO INSULIN PUMP
- K072009 — WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340
- K072154 — FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
- K072377 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
- K072476 — THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
- K072552 — MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
- K072553 — SYSTEM-ARMS, MODEL 390,E60
- K072654 — PATIENT SAFE SYRINGE
- K072657 — POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
- K072823 — MERILAS 532A
- K072832 — ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
- K073043 — SET PP
- K073251 — HYALOMATRIX PA
- K073284 — AIR-FLOW MASTER STANDARD
- K073409 — OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
- K063642 — FD EMS, MODEL # D-FJ30E
- K070225 — SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
- K070783 — SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
- K070899 — PURITAN BENNETT LEGENDAIR XL2
- K071746 — DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
- K072375 — SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
- K072511 — SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
- K072555 — EDTA PLUS
- K072594 — GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
- K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
- K072625 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
- K072670 — MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.