FDA 510(k) clearances — page 1371
clearances on record, most recent first.
Clearances — page 1371
137,001–137,100 of 175,890- K880224 — MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID
- K880349 — MODEL 759 CUSTOM IN-THE-EAR HEARING AID
- K880551 — MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
- K872996 — NATURAL-TOUCH (TM) SURGEON'S GLOVE
- K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
- K874825 — DISPOSABLE CAUTERIES
- K875225 — UMBILICAL ARTERY OXYGEN SENSOR
- K875227 — STERILE EMPTY VIALS
- K875290 — LUMBAR IMPACTION SET
- K880035 — DAEWOO LATEX SURGICAL GLOVE
- K880048 — BLADE, SURGICAL PREP RAZOR STRAIGHT
- K880150 — PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
- K880161 — ACKRAD PEDIATRIC C.P.A.P. SYSTEM
- K880211 — TSRH H/M HOOK HOLDER
- K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER
- K880216 — MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.
- K880304 — INSPIRON NEBULO BASIC EXTERNAL HEATER
- K880413 — PATELLAR TENDON GRAFT GUIDE
- K880450 — RESUSCI PATIENT FACE SHIELD
- K880571 — CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
- K880613 — ACCO(R) FACE MASK
- K880649 — TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
- K872482 — GAMBRO-ENGSTROM ERICA IV RESPIRATOR
- K874481 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290
- K874833 — ARC ADAPTER ASSEMBLY
- K874846 — GLUCOSE (HEXOKINASE)
- K874916 — TECHNICON CHEM 1(TM) SYSTEM
- K874946 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60
- K875038 — MENTOR UNISTENT URETERAL STENT SET
- K875098 — CIBA CORNING MODEL 644
- K875213 — SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE
- K880232 — NH REPLACEMENT GASTROSTOMY KIT
- K880240 — INSTANT EOSIN-ALCOHOLIC
- K880276 — AST (SGOT) REAGENT SET
- K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
- K880460 — TARGET STREP A
- K880494 — LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
- K880529 — CEILING MOUNTED TILTING TABLE TANGENT III
- K880530 — CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
- K880680 — KING SYSTEMS, BREATHING BAG
- K880716 — SLIDE CULTURE PLATE-POTATO FLAKE AGAR
- K880717 — SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR
- K871313 — ULTRA-FRESH DEODORANT
- K871555 — RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
- K872588 — CLEARFIL PHOTO POSTERIOR
- K873521 — BRONCHODILATOR TEE - 9056 SERIES
- K873989 — DOPPLEX ULTRASONIC DOPPLER SYSTEM
- K874400 — NON-ROTATING GOLD CYLINDER AND SCREW
- K874674 — AIK-100 ANESTHESIA INDUCTION KIT/TRAY
- K875119 — BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
- K875126 — MIC (SPECIFIC LINE) INSERTION KIT
- K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC
- K875166 — PHARMASEAL STERILE UMBILICAL CORD CLAMP
- K875188 — LUER LOCK CONNECTORS / RIDIG P.V.C.
- K880022 — TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON
- K880023 — TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON
- K880034 — CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT
- K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH
- K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP
- K880098 — VAN-TEC AUTO BIOPSY NEEDLE
- K880099 — VAN-TEC BLADDER EVACUATOR
- K880402 — CODMAN SURGICAL PATTIE
- K880590 — DISPOSABLE DENTAL PROBE/EXPLORER
- K870816 — KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
- K873159 — COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER
- K874620 — GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE
- K874694 — ADAP-TEMP, MODEL: AT-100
- K875101 — VIROGEN CMV ANTIBODY TEST
- K875131 — (SKD) CHOLESTEROL TEST KIT
- K875133 — CAVIT-W
- K880012 — REVISED LABELING FOR ADX BARBITURATES
- K880013 — REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
- K880015 — REVISED LABELING FOR ADX CANNABINOIDS
- K880175 — DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
- K880188 — SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
- K880218 — BINAX PROLACTIN IRMA DIAGNOSTIC KIT
- K880270 — MSI-DIFF PLUS
- K880275 — ALT (SGPT) REAGENT SET
- K880311 — WAKO(TM) AUTOKIT CHOLESTEROL
- K880344 — IQ ALKALINE PHOSPHATASE
- K880665 — MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
- K872573 — PHARMACLUSIVE (TM)
- K873100 — OLYMPUS ANGIOSCOPY SHEATH
- K873526 — PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM
- K874047 — ASTHMAKIT
- K874450 — SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
- K874567 — RESUSCITATOR
- K874733 — GUARDIAN, EEG BRAIN MONITORING SYSTEM
- K875016 — BIOSURGE MODEL ILVC-1
- K875064 — SCIMED INFLATION DEVICE, MODEL SM 2000
- K875073 — BREATHE-FREE
- K875080 — AIR VENT LINE CAT. NO. AVL-36
- K875090 — AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
- K875091 — ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT
- K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
- K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
- K875117 — CIBA CORNING BALANCED HEPARIN FOR CA++
- K875142 — PHASE II
- K875265 — NON-INVASIVE BLOOD PRESSURE MODULE
- K875352 — HI FLOW PORTABLE LIQUID OXYGEN UNIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.