FDA 510(k) clearances — page 1218
clearances on record, most recent first.
Clearances — page 1218
121,701–121,800 of 175,890- K910769 — SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
- K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
- K911298 — PRESSURE LIMITING ELBOW WITH MANOMETER PORT
- K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
- K911460 — .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
- K911721 — KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
- K911808 — GEMINI OPHTHALMIC SURGERY SYSTEM
- K912026 — DELFIA(R) 17 -OH-PROGESTERON KIT
- K912366 — MAINSTER HIGH MAGNIFICATION LASER LENS
- K895363 — BIOVISION EMERALD LASER PHOTOCOAGULATOR
- K901552 — (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
- K903418 — LATERALASE TM
- K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC
- K904583 — SONO-VU US(TM)
- K904600 — L582 TRANSDUCER
- K904890 — BARD ALFENTANIL INFUSER
- K905024 — TMP MANDIBULAR COMPRESSION SYSTEM
- K905613 — MTS KNEE SYSTEM
- K910177 — SEAL-RITE SILICONE EAR PLUG
- K910462 — POCKET DOP 3
- K910487 — VISUWELL SYPHILIS ANTIGEN
- K910602 — HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
- K910833 — COLOR VUE TM- MYCOPLASMA PNEUMONIAE
- K910910 — MOSS- ANCHOR SET
- K910916 — CATHLAB SILICONE OCCLUSION BALLOON CATHETER
- K910934 — FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
- K911045 — OBA(TM) READER
- K911047 — OBA(TM) SERUM HCG ASSAY
- K911324 — IRRIGATION/ASPIRATION TUBING SET
- K911341 — HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO
- K911353 — EMC MODEL NO. STATOME 900
- K911421 — CATHETER MOUNTS
- K911425 — ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
- K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
- K911449 — VITAL-PORT VASCULAR ACCESS SYSTEM
- K911496 — FASTTECH SYSTEM 1
- K911506 — MODEL 2100 PORTABLE FIELD UNIT
- K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
- K911753 — INTERVASCULAR ADMINSTRATION SET
- K911760 — MONARCH STERILIZATION CONTAINER SYST, MODIFICATION
- K911780 — INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
- K911868 — INTERLINK(TM) BLUNT CANNULA, MODIFICATION
- K912044 — MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
- K912149 — HARDCOATED PLASTIC FILLING INSTRUMENT
- K912348 — SX90 (TM),MODEL 4800S
- K912458 — MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
- K912544 — BIPOLAR FORCEPS
- K903013 — LYME IGM ELISA TEST
- K904239 — SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
- K904298 — EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR
- K904519 — AGFA DIAGNOSTIC CENTER (ADC)
- K904676 — NDI MODEL IRS-TD
- K905074 — MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
- K905083 — 4.5F IMAGECATH ANGIOSCOPE
- K905518 — BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
- K905526 — AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
- K910175 — FIXATION DEVICES AND BONE PLATE
- K910235 — PCA MTK II TOTAL KNEE SYSTEM
- K910419 — BIOCLONE'S ELEGANCE IGE ELISA KIT
- K910592 — ABUSCREEN FP FOR CANNABINOIDS (15-50)
- K911100 — MEHIGAN-PILLING PHLEBETOME TM
- K911348 — RIGID ENDOSCOPE
- K911394 — ISOLA(TM) SPINE SYSTEM--EYE ROD
- K911495 — MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
- K911638 — SYRINGE TIP CAP
- K911990 — ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
- K905575 — MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
- K910089 — MEGA LUMBAR PUNCTURE KIT
- K910580 — MICROSTIM 100 MODEL 2C
- K910734 — MEDISYSTEMS HEMODIALYSIS FISTULA SET
- K910963 — THOROCENTESIS KIT
- K911262 — DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
- K911274 — UNIPOLAR COAGULATOR PROBE SYSTEM
- K911453 — OBTRASOUND STETHOSCOPE FETAL CALC
- K911480 — FLEXIBLE CHOLEDOCHOSCOPE
- K911635 — MEADOX(R) SURGIMED(R) BIOPSY GUN II
- K911796 — IMMULITE(TM) HCG
- K911892 — RX-5000 MRI SYSTEM
- K912204 — TELEX MODEL TLP, IN-THE-EAR
- K912241 — STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
- K912324 — NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY
- K912601 — BIPROBE(TM)
- K903966 — EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
- K904863 — MGA-IR SIDESTREAM PCO2 MODULE
- K905154 — GASTROSCAN
- K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
- K905563 — INTRAN PLUS
- K905573 — XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
- K910238 — PORTABLE AUTO TRANSFUSION SYSTEM 500
- K910247 — ZODIAC 901 MIDDLE-EAR ANALYZER
- K910990 — OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
- K911243 — CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP
- K911695 — VARIOUS X-RAY TUBES
- K912469 — BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
- K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM
- K904631 — CENTAURI YAG LASER SYST, NEUROSURGERY
- K905383 — 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY
- K910128 — LEVTECH TITANIUM BONE WIRE
- K910699 — LIFE-02 (NON-REFILLABLE CYLINDER)
- K910856 — MANUAL RESUSCITATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.