FDA 510(k) clearances — page 649
clearances on record, most recent first.
Clearances — page 649
64,801–64,900 of 176,637- K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
- K052381 — GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
- K052702 — MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY
- K052837 — SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
- K053000 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
- K053045 — MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K050398 — EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
- K051144 — ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
- K051149 — MEDITECH MODEL ABPM-04
- K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
- K051330 — UVBIOTEK MODELS 3200B AND 4000B
- K051578 — IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
- K051620 — MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
- K051713 — JBAIDS ANTHRAC DETECTION SYSTEM
- K051722 — TRICOS T
- K051826 — BETACONE HIP PROSTHESIS SYSTEM
- K052033 — VINTAGE ZR
- K052502 — NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
- K052530 — SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
- K052679 — CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E
- K052851 — VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
- K052905 — MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
- K052961 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
- K053043 — ENCOMPASS SOFTWARE PACKAGE
- K053151 — RUBICOR MAGIC BREAST BIOPSY DEVICE
- K043367 — GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
- K050024 — ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
- K051111 — SENTINEL UIBC LIQUID
- K051226 — AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
- K051568 — CADD-MS 3 AMBULATORY INFUSION PUMP
- K051572 — KOKO LEGEND
- K051759 — FLEXI-LITE, MODEL FL-V1.2
- K051929 — GIARDIA/CRYPTOSPORIDIUM CHEK
- K052169 — IMC SURGICAL DRAPES
- K052313 — STIMUPLEX HNS-12, MODEL 4892098
- K052377 — PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
- K052408 — EZ-IO
- K052413 — TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
- K052550 — IMC SURGICAL GOWNS
- K052565 — ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
- K052618 — IMAGECAST PACS
- K052853 — TIGECYCLINE 15UG BBL SENSI-DISC
- K052899 — ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
- K052938 — CR-PRO
- K053009 — GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
- K053042 — MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
- K051658 — INFINITY ALPHA
- K052252 — CONTRAST MEDIA TRANSFER SETS
- K052405 — STERLING INTERFERENC SCREW HT
- K052414 — REPROCESSED ELECTROPHYSIOLOGY CATHETER
- K052518 — PIEZOSURGERY
- K052537 — CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
- K052603 — REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
- K052624 — INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
- K052699 — VERSA-LINK PORCELAIN BONDING SYSTEM
- K052931 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K052950 — THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
- K052958 — COLOR NIO 2MP, E-2320 C
- K052969 — SLENDERTONE GYMBODY, MODEL 512-01
- K052971 — STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
- K053017 — MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
- K053053 — PACP SYSTEM
- K053069 — SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
- K053084 — SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
- K051023 — TOPEZ TOTAL ANKLE REPLACEMENT
- K051711 — PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
- K052526 — NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
- K052596 — MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
- K052861 — MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
- K053014 — POLY SILOXANE IMPRESSION MATERIAL
- K053114 — SILVERFIL
- K050473 — RBK PATELLA FEMORAL KNEE
- K051492 — AESKULISA ASCA A
- K051886 — OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
- K052852 — SUPERDIMENSION/BRONCHUS PREMIUM
- K052876 — TELITHROMYCIN 15UG BBL SENSI-DISC
- K040832 — C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050
- K051450 — EXTENDED MEASUREMENTS SYSTEM
- K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
- K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
- K052201 — SOLANAS POSTERIOR STABILIZATION SYSTEM
- K052256 — ANGIOJET XPEEDIOR 120 CATHETER
- K052331 — ACUSON CYPRESS ULTRASOUND SYSTEM
- K052474 — NIPRO HYPODERMIC NEEDLE
- K052605 — EXTERNAL FIXATION
- K052636 — TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
- K052703 — ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
- K052763 — STELLA CERVICAL PLATE
- K052829 — WRISTOX MODEL 3100 PULSE OXIMETER
- K052860 — CG FUTURE ANNULOPLASTY BAND
- K053025 — JOSTRA HLM TUBING SET
- K053026 — KOWA NONMYD 7, KOWA NONMYD A-D
- K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
- K050609 — AQUADEX SYSTEM
- K052075 — PROCEDUR-10
- K052148 — TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
- K052228 — SMIT SLEEVE
- K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
- K052393 — B. BRAUN MODIFIED BICARBONATE DIALYSATE
- K052647 — CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.
Data sourced from openFDA. This site is unofficial and independent of the FDA.