FDA 510(k) clearances — page 1347
clearances on record, most recent first.
Clearances — page 1347
134,601–134,700 of 175,890- K883613 — OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.
- K883614 — CYTOGUARD(R)
- K883657 — SKID RESISTANT, LONG LASTING SHOE COVERS
- K883771 — SUNGLASSES, IMPORTED
- K870722 — LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
- K881478 — MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
- K881697 — BREAST LESION LOCALIZATION NEEDLE
- K882052 — OMEGA NV(TM) BALLOON DILATATION CATHETER
- K882311 — SHIMADZU LATERAL C-ARM MH-31
- K882394 — MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
- K882557 — COULTER CLONE B1 MONOCLONAL ANTIBODY
- K883072 — DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM
- K883087 — PROLOG MP 658M PULSE GENERATOR
- K883434 — AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
- K883622 — INSTRUMENTARIUM ULF MR IMAGING SYSTEM
- K875280 — STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
- K882089 — MRM GASTROSTOMY BELT
- K882218 — COMPAT (R) ENTERAL DELIVERY SYSTEM
- K882295 — FILLING VOLUME OPTION
- K882689 — PUNCH MYRINGOTOMY SYSTEM
- K883195 — FRESENIUS F8 DIALYZER
- K883209 — TECHNICON RA-100(TM) SYSTEM
- K883247 — LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
- K883269 — PRL-QUANT
- K883302 — EMAX PRECISION MICROPLATE READER
- K883342 — VENTREX COATED TUBE TSH
- K883353 — IQ HDL CHOLESTEROL
- K883396 — HANDSWITCHING MONOPOLAR PENCIL
- K883404 — URIC ACID REAGENT (PRODUCT #88219)
- K883405 — TRIGLYCERIDES REAGENT (PRODUCT #88218)
- K883428 — BIOTROL URIC ACID ENZYMATIQUE TRINDER
- K883441 — VISION(R) PROTHROMBIN TIME
- K883474 — THORACIC CATHETERS
- K883485 — STRYKER PRESSURE MONITOR SYSTEM
- K883504 — DURAZYME(R) CPK
- K883578 — S 21 INSTRUMENT STAND
- K883581 — OPMI CS
- K883671 — 805 POWER CHAIR CONVERSION SYSTEM
- K883672 — PARALYZED VETERANS OF AMERICA POWER RECLINER
- K883673 — POWER MECHANICAL RECLINER
- K883674 — MANUAL SWING ARM
- K883678 — 4007 MODEL RECLINER CONTROLLER
- K883679 — WHEELS-OFF QUICK RELEASE AXLE SYSTEM
- K880287 — TRU-TRAC COILED GUIDEWIRE
- K880288 — TRU-TRAC TORQUE GUIDEWIRE
- K881049 — BRADBURY INTRAOCULAR RETINAL KIT CAT #200
- K881469 — ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
- K882474 — OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
- K882476 — OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
- K882762 — COLLAGEN SHIELD
- K882879 — PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)
- K883095 — MX860, REUSABLE PRESSURE TRANSDUCER
- K883254 — MULTINEX MONITOR (MODIFICATION)
- K883341 — HEARTSTART 1000
- K883344 — HEARTSTART 1000S
- K883431 — RAYMAX 2100 MODELS 2130 & 2136
- K883575 — MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
- K881320 — URINE TOXICOLOGY STANDARD
- K881616 — PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
- K881631 — BIODYNAMICS AUTOTRANSFUSION RESERVOIR
- K882002 — PREGNAGEN(TM)
- K882379 — MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
- K882403 — OPHTHALMIC FLUID INJECTOR
- K882506 — MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
- K882536 — OPHTHALMIC PAO VALVE
- K882647 — GESCO CATHETERIZATION TRAY
- K882734 — KTP/YAG(TM) SURGICAL LASER
- K882926 — MODEL AU-1 ACCESSORY UNIT
- K882938 — STAT FAX(TM)
- K882941 — BLOOD GAS MIXTURE
- K883012 — A.QC CHEMISTRY CONTROL LEVEL 2
- K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
- K883190 — DADE TDM CONTROL
- K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT
- K883206 — LACTATE DEHYDROGENASE LDH
- K883279 — PHASE II FSH KIT
- K883459 — DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
- K881412 — MYOCARD BIOPSY FORCEP
- K881519 — VAC-G (GUILLOTINE VITRECTOR)
- K881701 — RADKOR SFC-21
- K882015 — TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM
- K882451 — OLYMPUS REPLY CHEMISTRY ANALYZER
- K882477 — ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL
- K882552 — METATECH ROBINSON BOLT ACCESSORY
- K882737 — ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER
- K883096 — TRACHEAL TUBE LASER SHIELD KIT
- K883160 — CATAPULT BUCKY (KATAPULT BLENDA)
- K880973 — MICROLYTE 7
- K881520 — VAC (OSCILLATING VITRECTOR)
- K882579 — HEMATRAK(R) MODEL 590
- K882612 — SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER
- K882998 — ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
- K883076 — GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
- K883232 — HISTONE REACTIVE ANA
- K883273 — DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
- K883349 — QLIA IMMUNOCHEMISTRY SYSTEM
- K883355 — UBI MAGIWEL RF-IGM QUANTITATIVE
- K883385 — RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
- K883394 — GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
- K883491 — TECHNICON DPA-1 APOLIPOPROTEIN B
Data sourced from openFDA. This site is unofficial and independent of the FDA.